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Dose-ranging Efficacy of Polydextrose Supplement on Colonic Transit Time and Symptoms in Adults With Functional Constipation

Sponsor
KGK Science Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02314936
Collaborator
DuPont Nutrition and Health (Industry)
192
Enrollment
1
Location
4
Arms
13
Duration (Months)
14.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will investigate the effectiveness of Polydextrose, a dietary fiber, at decreasing Colonic Transit Time and the gastrointestinal symptoms of Functional Constipation. One quarter of the subjects will receive 12 g of Polydextrose daily, one quarter will receive 8 g of Polydextrose daily, one quarter will receive 4 g of Polydextrose daily and one quarter will receive a placebo daily.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Litesse powder containing 12 g polydextrose
  • Dietary Supplement: Litesse powder containing 8 g polydextrose
  • Dietary Supplement: Litesse powder containing 4 g polydextrose
  • Dietary Supplement: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
192 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Dose-ranging Efficacy of Supplementation With Polydextrose, a Dietary Fibre, on Colonic Transit Time and Gastrointestinal Symptoms in Adults With Functional Constipation: A Double-blind, Randomized, Placebo-controlled Trial
Study Start Date :
Apr 1, 2015
Actual Primary Completion Date :
Apr 1, 2016
Actual Study Completion Date :
May 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Litesse powder containing 12 g polydextrose

12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks

Dietary Supplement: Litesse powder containing 12 g polydextrose
12 g polydextrose
Other Names:
  • Litesse powder

    		•
    Experimental: Litesse powder containing 8 g polydextrose

    8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks

    Dietary Supplement: Litesse powder containing 8 g polydextrose
    8 g polydextrose, 4 g maltodextrin
    Other Names:
  • Litesse powder

    		•
    Experimental: Litesse powder containing 4 g polydextrose

    4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks

    Dietary Supplement: Litesse powder containing 4 g polydextrose
    4 g polydextrose, 8 g maltodextrin
    Other Names:
  • Litesse powder

    		•
    Placebo Comparator: Placebo

    Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks

    Dietary Supplement: Placebo
    12 g Maltodextrin

    Outcome Measures

    Primary Outcome Measures

    1. Change in Colonic Transit Time From Baseline to Day 15 [Baseline and Day 15]

      Assessed using abdominal x-ray. Subjects will take 24 radiopaque markers for 6 consecutive days (144 radiopaque markers in total) immediately preceding the x-ray dates.

    Secondary Outcome Measures

    1. Change in Participant Assessment of Constipation Symptoms (PAC-SYM) From Baseline to Day 15 [Baseline and Day 15]

      Assessed using the PAC-SYM questionnaire (overall score, abdominal symptoms score, rectal symptoms score, and stool symptoms score). The PAC-SYM was developed as a brief, easily administered tool to assess symptom frequency and severity of chronic constipation. The authors used a definition for constipation was based on the Rome II criteria. This 12-item self-report measure is divided into the 3 symptom subscales of: abdominal, rectal and stool subscales. All items (sub-scores and the total score) are scored on a five-point Likert scale ranging from 0 (absence of symptom) to 4 (very severe) where lower scores are better. Scores for the total number of non-missing items within the subscale or total score are summed and divided by the total number of non-missing items for that subscale or total score.

    2. Change in Participant Assessment of Constipation Quality of Life (PAC-QoL) From Baseline to Day 15 [Baseline and Day 15]

      Assessed using the PAC-QoL questionnaire (Overall Score, Worries and Concerns Score, Physical Discomfort Score, Psychosocial Discomfort Score, and Satisfaction Score) The Patient Assessment of Constipation (PAC) was developed to address the need for a disease-specific patient-reported outcomes measure. It includes components from complementary symptom and quality of life questionnaires. The PAC-QOL contains 28 items grouped into 4 subscales covering: worries and concerns (11 items), physical discomfort (4 items), psychosocial discomfort (8 items), and satisfaction (5 items). A 5-point Likert response scale, ranging from 0 (not at all / none of the time) to 4 (extremely / all of the time), where lower scores are better. Scores are computed as the average non-missing item response within the subscale where each score is given equal weight; the global score is calculated as the mean of the 28-items.

    3. Change in Bowel Function Index From Baseline to Day 15 [Baseline and Day 15]

      Assessed using the Bowel Function Index questionnaire (total score, ease of defecation, feeling of incomplete bowel evacuation, and personal judgement of constipation). Each of the three questions used a numerical analog scale (0 = easy/no difficulty/not at all, 100 = very strong/very difficult) for grading purposes. The three questions were calculated as single scores as well as by a total score defined as the average of the three questions.

    4. Change in Adequate Relief of Constipation Symptoms From Baseline to Day 15 [Baseline and Day 15]

      Assessed using single question dichotomous tool. Adequate relief quantified the difference in the number of participants experiencing relief from constipation between participants supplemented with Litesse and those supplemented with a placebo at baseline and day 14. The units of analysis for the relief questionnaire were the number of participants who reported relief from constipation.

    5. Change in Stool Frequency From Baseline to Day 15 [14 day run-in and Week 2 of the 14-day supplementation period]

      Participants will record the number of defecations per day in a daily diary

    6. Change in Stool Consistency From Baseline to Day 15 [14 day run-in and Week 2 of the 14-day supplementation period]

      Stool consistency will be rated each day in a diary by using the Bristol Stool Scale Form. Bristol Stool Scale: The BSS is a categorical scale ranging from 1 to 7 that interprets the consistency of a single bowel movement; a single score is recorded and used for analysis. Lower scores are associated with hard and lumpy consistencies while higher scores are associated with soft or liquid consistencies. Generally, an optimal BSS scores ranges from 3 to 5.

    7. Change in the Degree of Straining During Defecation From Baseline to Day 15 [14 day run-in and Week 2 of the 14-day supplementation period]

      Degree of straining for each bowel movement will be recorded in a daily diary using a 5-point scale. The degree of straining is a rating scale ranging from 1 (not at al) to 5 (an extreme amount) that interprets the degree to which an individual must strain during a unique defecation; a single core is recorded and used for analysis. Scores were calculated as the weekly average of the daily degree of straining (1-5) where a lower score represented less straining.

    8. Change in the Sensation of Complete Bowel Emptying From Baseline to Day 15 [14 day run-in and Week 2 of the 14-day supplementation period]

      Sensation of complete bowel emptying for each bowel movement will be recorded in a daily diary on a dichotomous "yes" or "no" scale. The change in the sensation was defined as the change from baseline to week 2 in the percentage of complete bowel movements (CBMs) between participants supplemented with Litesse and those supplemented with a placebo. It assessed whether the participant felt as though their bowel movement was complete. The units of analysis for the sensation of complete bowel emptying was the weekly percentage of complete bowel movements, for each participant at run-in (week -1), week 1 and week 2.

    9. Change in the Severity of Abdominal Discomfort From Baseline to Day 15 [14 day run-in and Week 2 of the 14-day supplementation period]

      Severity of abdominal discomfort will be recorded each day in a daily diary on a 5-point scale. The severity of abdominal discomfort was calculated from a rating scale ranging from 1 (not at all) to 5 very severe); a single score was recorded and used for analysis. Scores were calculated as the weekly average of the daily degree of discomfort where a lower score represented less straining.

    10. Change in the Bloating Severity From Baseline to Day 15 [14 day run-in and Week 2 of the 14-day supplementation period]

      Severity of bloating will be recorded each day in a daily diary on a 5-point scale. The severity of abdominal bloating was calculated from a rating scale ranging from 1 (not at all) to 5 very severe); a single score was recorded and used for analysis. Scores were calculated as the weekly average of the daily degree of bloating where a lower score represented less straining.

    11. Overall Product Satisfaction [Assessed at Day 15 (end of study)]

      Participants will be asked to rate their overall satisfaction with the study product's ability to relieve their constipation symptoms on a 5-point ordinal scale. The overall product satisfaction questionnaire consists of a single question that provides insight regarding the participants satisfaction on the product's ability to relieve constipation symptoms. The score that the participant indicates is considered the total score and no sub-scores are calculated. It is a rating scale that ranges from 1 (not at all satisfied) to 5 (very satisfied) where a higher score at the end-of-study indicates an improvement.

    Other Outcome Measures

    1. Change in Hemoglobin Levels From Baseline to Day 15 [Screening and Day 15 (end of study)]

      Safety will be evaluated by measuring whole blood hematology (specifically hemoglobin in this outcome).

    2. Change in Hematocrit Levels From Screening to Day 15 [Screening and Day 15 (end of study)]

      Safety will be evaluated by measuring the change in whole blood hematology (specifically hematocrit levels in this outcome).

    3. Change in White Blood Cell Count From Baseline to Day 15 [Screening and Day 15 (end of study)]

      Safety will be evaluated by measuring whole blood hematology (specifically white blood cell count in this outcome measure).

    4. Change in Red Blood Cell Count From Baseline to Day 15 [Screening and Day 15 (end of study)]

      Safety will be evaluated by measuring whole blood hematology (specifically red blood cell count in this outcome measure).

    5. Change in Mean Corpuscular Volume From Baseline to Day 15 [Screening and Day 15 (end of study)]

      Safety will be evaluated by measuring whole blood hematology (specifically mean corpuscular volume in this outcome measure).

    6. Change in Mean Corpuscular Hemoglobin From Baseline to Day 15 [Screening and Day 15 (end of study)]

      Safety will be evaluated by measuring whole blood hematology (specifically mean corpuscular hemoglobin in this outcome measure).

    7. Change in Mean Corpuscular Hemoglobin Concentration From Baseline to Day 15 [Screening and Day 15 (end of study)]

      Safety will be evaluated by measuring whole blood hematology (specifically mean corpuscular hemoglobin concentration in this outcome measure).

    8. Change in Red Cell Distribution Width From Baseline to Day 15 [Screening and Day 15 (end of study)]

      Safety will be evaluated by measuring whole blood hematology (specifically red cell distribution width in this outcome measure).

    9. Change in Platelet Count From Baseline to Day 15 [Screening and Day 15 (end of study)]

      Safety will be evaluated by measuring whole blood hematology (specifically platelet count in this outcome measure).

    10. Change in Neutrophil Count From Baseline to Day 15 [Screening and Day 15 (end of study)]

      Safety will be evaluated by measuring whole blood hematology (specifically neutrophil count in this outcome measure).

    11. Change in Lymphocyte Count From Baseline to Day 15 [Screening and Day 15 (end of study)]

      Safety will be evaluated by measuring whole blood hematology (specifically lymphocyte count in this outcome measure).

    12. Change in Monocyte Count From Baseline to Day 15 [Screening and Day 15 (end of study)]

      Safety will be evaluated by measuring whole blood hematology (specifically monocyte count in this outcome measure).

    13. Change in Eosinophil Count From Baseline to Day 15 [Screening and Day 15 (end of study)]

      Safety will be evaluated by measuring whole blood hematology (specifically eosinophil count in this outcome measure).

    14. Change in Basophil Count From Baseline to Day 15 [Screening and Day 15 (end of study)]

      Safety will be evaluated by measuring whole blood hematology (specifically basophil count in this outcome measure).

    15. Change in Serum Glucose Concentration From Baseline to Day 15 [Screening and Day 15 (end of study)]

      Safety will be evaluated by measuring blood serum variables (specifically glucose concentration in this outcome measure).

    16. Change in Creatinine Levels in Blood From Baseline to Day 15 [Screening and Day 15 (end of study)]

      Safety will be evaluated by measuring blood serum variables (specifically creatinine concentration in this outcome measure).

    17. Change in Serum Urea Concentration From Baseline to Day 15 [Screening and Day 15 (end of study)]

      Safety will be evaluated by measuring blood serum variables (specifically urea concentration in this outcome measure).

    18. Change in Serum Estimated Globular Filtration Rate From Baseline to Day 15 [Screening and Day 15 (end of study)]

      Safety will be evaluated by measuring blood serum variables (specifically estimated glomerular filtration rate in this outcome measure).

    19. Change in Serum Sodium Concentration From Baseline to Day 15 [Screening and Day 15 (end of study)]

      Safety will be evaluated by measuring blood serum variables (specifically sodium concentration in this outcome measure).

    20. Change in Serum Potassium Concentration From Baseline to Day 15 [Screening and Day 15 (end of study)]

      Safety will be evaluated by measuring blood serum variables (specifically potassium concentration in this outcome measure).

    21. Change in Serum Chloride Concentration From Baseline to Day 15 [Screening and Day 15 (end of study)]

      Safety will be evaluated by measuring blood serum variables (specifically chloride concentration in this outcome measure).

    22. Change in Serum Calcium Concentration From Baseline to Day 15 [Screening and Day 15 (end of study)]

      Safety will be evaluated by measuring blood serum variables (specifically calcium concentration in this outcome measure).

    23. Change in Serum Carbon Dioxide Concentration From Baseline to Day 15 [Screening and Day 15 (end of study)]

      Safety will be evaluated by measuring blood serum variables (specifically carbon dioxide concentration in this outcome measure).

    24. Change in Serum Phosphate Concentration From Baseline to Day 15 [Screening and Day 15 (end of study)]

      Safety will be evaluated by measuring blood serum variables (specifically phosphate concentration in this outcome measure).

    25. Change in Serum Bilirubin Concentration From Baseline to Day 15 [Screening and Day 15 (end of study)]

      Safety will be evaluated by measuring blood serum variables (specifically bilirubin concentration in this outcome measure).

    26. Change in Serum Aspartate Transaminase Concentration From Baseline to Day 15 [Screening and Day 15 (end of study)]

      Safety will be evaluated by measuring blood serum variables (specifically aspartate transaminase concentration in this outcome measure).

    27. Change in Serum Alanine Transaminase Concentration From Baseline to Day 15 [Screening and Day 15 (end of study)]

      Safety will be evaluated by measuring blood serum variables (specifically alanine transaminase concentration in this outcome measure).

    28. Change in Serum Alkaline Phosphate Concentration From Baseline to Day 15 [Screening and Day 15 (end of study)]

      Safety will be evaluated by measuring blood serum variables (specifically alkaline phosphate concentration in this outcome measure).

    29. Change in Serum Gamma-Glutamyltransferase Concentration From Baseline to Day 15 [Screening and Day 15 (end of study)]

      Safety will be evaluated by measuring blood serum variables (specifically gamma-glutamyltransferase concentration in this outcome measure).

    30. Change in Serum C-Reactive Protein Concentration From Baseline to Day 15 [Screening and Day 15 (end of study)]

      Safety will be evaluated by measuring blood serum variables (specifically C-reactive protein concentration in this outcome measure).

    31. Change in Specific Gravity Urinalysis Parameter From Screening to Day 15 [Screening and Day 15 (end of study)]

      Safety will be evaluated by measuring urine analyses (specifically specific gravity in this outcome measure). The reference range for specific gravity are 1.001 - 1.030 mmol/L, with no alerting or critical values.

    32. Change in pH Urinalysis Parameter From Baseline to Day 15 [Screening and Day 15 (end of study)]

      Safety will be evaluated by measuring urine analyses (specifically urine pH in this outcome measure). Urine pH reference range is between 5.0 - 8.0, with no alerting or critical values.

    33. Number of Subjects With Adverse Events [14 days run-in and 14 days treatment]

      Adverse events were recorded in a daily diary during the 14-day run-in period and the 14-day treatment period. All types of adverse events as well as the total number of all adverse events reported were used in this outcome measure.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Age between 18 and 70 years.

    2. Body mass index between 18.5 and 29.9 kg/m2 (encompasses normal weight and overweight).

    3. If female, subject is not of child bearing potential. Defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation).

    OR

    Female subject of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include:

    Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System), Intrauterine devices, Double barrier method, Vasectomy of partner (shown successful as per appropriate follow-up), Tubal ligation, and Non-heterosexual lifestyle (same sex partner).

    1. Meets the Rome III criteria for functional constipation as follows: (Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis):
    Must meet 2 or more of the following criteria:

    Straining during at least 25% of defecations, Lumpy or hard stools in at least 25% of defecations, Sensation of incomplete evacuation for at least 25% of defecations, Sensation of anorectal obstruction/blockage for at least 25% of defecations, Manual maneuvers to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor)

    Fewer than three defecations per week

    Loose stools are rarely present without the use of laxatives

    Insufficient criteria for irritable bowel syndrome

    1. Ability of the participant (in the investigator's opinion) to comprehend the full nature and purpose of the study including possible risks and side effects.

    2. Consent to the study and willing to comply with study product and methods.

    3. Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research.

    Exclusion Criteria:

    1. Major gastrointestinal complication (e.g. Crohn's disease, colitis, celiac disease)

    2. Prior abdominal surgery that in the opinion of the investigator may present a risk for the subject or confound study results.

    3. Clinically significant underlying systemic illness that may preclude the participant's ability to complete the trial or that may confound the study outcomes (e.g. bowel cancer, prostate cancer, terminal illness).

    4. Daily consumption of probiotics, prebiotics, fermented milk, and/or yogurt within 2 weeks of screening and throughout the trial other than the provided study products.

    5. Laxative use within 48 hours of screening (rescue medication allowed for intolerable symptoms during study).

    6. Regular use of any drug or dietary supplement known to cause constipation (e.g. iron, opioids, sucralfate, misoprostol, 5-HT#-antagonists, antacids with magnesium, calcium or aluminum, antidiarrheal medication, anticholinergic agents, calcium supplements, calcium channel blockers, tricyclic antidepressants or NSAIDs), within 1 month before screening.

    7. Anticipated major dietary or exercise changes during the study.

    8. Systemic steroid use, within 1 month before screening.

    9. Eating disorder.

    10. Contraindication to dairy products (e.g., intolerance to lactose or any substance in the study product).

    11. History of alcohol, drug, or medication abuse.

    12. Pregnant or lactating female, or pregnancy planned during study period.

    13. Participation in another study with any investigational product within 60 days of screening.

    14. Investigator believes that the participant may be uncooperative and/or noncompliant and should therefore not participate in the study.

    15. Subject under administrative or legal supervision.

    16. Subject who would receive more than 4500 Euros as indemnities for his participation in biomedical research within the 12 last months, including the indemnities for the present study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 KGK Synergize Inc. London Ontario Canada N6A 5R8

    Sponsors and Collaborators

    • KGK Science Inc.
    • DuPont Nutrition and Health

    Investigators

    • Principal Investigator: Tetyana Pelipyagina, MD, KGK Science Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    KGK Science Inc.
    ClinicalTrials.gov Identifier:
    NCT02314936
    Other Study ID Numbers:
    • 01-2014
    First Posted:
    Dec 11, 2014
    Last Update Posted:
    Nov 9, 2018
    Last Verified:
    Apr 1, 2018
    Keywords provided by KGK Science Inc.
    Constipation
    Polydextrose
    Dietary Fiber
    PAC-QoL
    Colonic Transit Time
    PAC-SYM
    Additional relevant MeSH terms:
    Constipation

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo
    Arm/Group Description 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin
    Period Title: Overall Study
    STARTED 48 48 48 48
    COMPLETED 48 48 46 48
    NOT COMPLETED 0 0 2 0

    Baseline Characteristics

    Arm/Group Title Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo Total
    Arm/Group Description 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin Total of all reporting groups
    Overall Participants 48 48 48 48 192
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    42.9
    (16.3)
    42.9
    (12.5)
    41.5
    (17.1)
    43.6
    (13.4)
    42.7
    (14.8)
    Sex: Female, Male (Count of Participants)
    Female
    34
    70.8%
    34
    70.8%
    32
    66.7%
    33
    68.8%
    133
    69.3%
    Male
    14
    29.2%
    14
    29.2%
    16
    33.3%
    15
    31.3%
    59
    30.7%
    Race/Ethnicity, Customized (Count of Participants)
    Black or African American
    2
    4.2%
    0
    0%
    0
    0%
    0
    0%
    2
    1%
    Central American
    2
    4.2%
    1
    2.1%
    0
    0%
    1
    2.1%
    4
    2.1%
    East Asian
    1
    2.1%
    0
    0%
    1
    2.1%
    2
    4.2%
    4
    2.1%
    Eastern European White
    0
    0%
    3
    6.3%
    0
    0%
    5
    10.4%
    8
    4.2%
    Middle Eastern
    2
    4.2%
    1
    2.1%
    2
    4.2%
    1
    2.1%
    6
    3.1%
    North American Indian
    0
    0%
    0
    0%
    2
    4.2%
    0
    0%
    2
    1%
    South American
    0
    0%
    6
    12.5%
    3
    6.3%
    3
    6.3%
    12
    6.3%
    South Asian
    3
    6.3%
    1
    2.1%
    0
    0%
    1
    2.1%
    5
    2.6%
    South East Asian
    2
    4.2%
    0
    0%
    0
    0%
    0
    0%
    2
    1%
    Western European White
    36
    75%
    36
    75%
    40
    83.3%
    35
    72.9%
    147
    76.6%
    Body Mass Index (kg/m^2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg/m^2]
    25.27
    (3.06)
    25.31
    (3.09)
    25.32
    (2.82)
    25.23
    (2.48)
    25.28
    (2.85)
    Smoking Status (Count of Participants)
    Ex-Smoker
    7
    14.6%
    8
    16.7%
    3
    6.3%
    7
    14.6%
    25
    13%
    Non-Smoker
    34
    70.8%
    36
    75%
    40
    83.3%
    35
    72.9%
    145
    75.5%
    Current Smoker
    7
    14.6%
    4
    8.3%
    5
    10.4%
    6
    12.5%
    22
    11.5%
    Alcohol Use (Count of Participants)
    Daily
    0
    0%
    2
    4.2%
    2
    4.2%
    1
    2.1%
    5
    2.6%
    None
    9
    18.8%
    5
    10.4%
    9
    18.8%
    9
    18.8%
    32
    16.7%
    Occasionally
    27
    56.3%
    25
    52.1%
    21
    43.8%
    27
    56.3%
    100
    52.1%
    Weekly
    12
    25%
    16
    33.3%
    16
    33.3%
    11
    22.9%
    55
    28.6%

    Outcome Measures

    1. Primary Outcome
    Title Change in Colonic Transit Time From Baseline to Day 15
    Description Assessed using abdominal x-ray. Subjects will take 24 radiopaque markers for 6 consecutive days (144 radiopaque markers in total) immediately preceding the x-ray dates.
    Time Frame Baseline and Day 15

    Outcome Measure Data

    Analysis Population Description
    The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).
    Arm/Group Title Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo
    Arm/Group Description 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin
    Measure Participants 45 43 43 42
    Mean (Standard Deviation) [Hours]
    -1.7
    (23.6)
    4.0
    (23.4)
    2.5
    (23.7)
    2.6
    (25.9)
    2. Secondary Outcome
    Title Change in Participant Assessment of Constipation Symptoms (PAC-SYM) From Baseline to Day 15
    Description Assessed using the PAC-SYM questionnaire (overall score, abdominal symptoms score, rectal symptoms score, and stool symptoms score). The PAC-SYM was developed as a brief, easily administered tool to assess symptom frequency and severity of chronic constipation. The authors used a definition for constipation was based on the Rome II criteria. This 12-item self-report measure is divided into the 3 symptom subscales of: abdominal, rectal and stool subscales. All items (sub-scores and the total score) are scored on a five-point Likert scale ranging from 0 (absence of symptom) to 4 (very severe) where lower scores are better. Scores for the total number of non-missing items within the subscale or total score are summed and divided by the total number of non-missing items for that subscale or total score.
    Time Frame Baseline and Day 15

    Outcome Measure Data

    Analysis Population Description
    The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).
    Arm/Group Title Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo
    Arm/Group Description 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin
    Measure Participants 45 43 43 42
    Overall Score
    -0.24
    (0.59)
    -0.13
    (0.39)
    -0.04
    (0.44)
    -0.21
    (0.56)
    Abdominal Symptoms Score
    -0.13
    (0.69)
    -0.06
    (0.51)
    -0.01
    (0.56)
    -0.15
    (0.60)
    Rectal Symptoms Score
    -0.28
    (0.71)
    -0.16
    (0.46)
    0.06
    (0.60)
    -0.21
    (0.59)
    Stool Symptoms Score
    -0.31
    (0.82)
    -0.16
    (0.68)
    -0.18
    (0.62)
    -0.28
    (0.82)
    3. Secondary Outcome
    Title Change in Participant Assessment of Constipation Quality of Life (PAC-QoL) From Baseline to Day 15
    Description Assessed using the PAC-QoL questionnaire (Overall Score, Worries and Concerns Score, Physical Discomfort Score, Psychosocial Discomfort Score, and Satisfaction Score) The Patient Assessment of Constipation (PAC) was developed to address the need for a disease-specific patient-reported outcomes measure. It includes components from complementary symptom and quality of life questionnaires. The PAC-QOL contains 28 items grouped into 4 subscales covering: worries and concerns (11 items), physical discomfort (4 items), psychosocial discomfort (8 items), and satisfaction (5 items). A 5-point Likert response scale, ranging from 0 (not at all / none of the time) to 4 (extremely / all of the time), where lower scores are better. Scores are computed as the average non-missing item response within the subscale where each score is given equal weight; the global score is calculated as the mean of the 28-items.
    Time Frame Baseline and Day 15

    Outcome Measure Data

    Analysis Population Description
    The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).
    Arm/Group Title Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo
    Arm/Group Description 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin
    Measure Participants 45 43 43 42
    Overall Score
    -0.05
    (0.36)
    -0.04
    (0.45)
    -0.08
    (0.33)
    -0.11
    (0.33)
    Worries and Concerns Score
    -0.27
    (0.59)
    -0.17
    (0.54)
    -0.15
    (0.46)
    -0.13
    (0.60)
    Physical Discomfort Score
    -0.24
    (0.74)
    -0.23
    (0.73)
    -0.13
    (0.58)
    -0.20
    (0.75)
    Psychosocial Discomfort Score
    -0.12
    (0.53)
    -0.11
    (0.58)
    -0.17
    (0.52)
    -0.09
    (0.53)
    Satisfaction Score
    0.44
    (0.98)
    0.37
    (0.75)
    0.12
    (0.67)
    -0.02
    (0.69)
    4. Secondary Outcome
    Title Change in Bowel Function Index From Baseline to Day 15
    Description Assessed using the Bowel Function Index questionnaire (total score, ease of defecation, feeling of incomplete bowel evacuation, and personal judgement of constipation). Each of the three questions used a numerical analog scale (0 = easy/no difficulty/not at all, 100 = very strong/very difficult) for grading purposes. The three questions were calculated as single scores as well as by a total score defined as the average of the three questions.
    Time Frame Baseline and Day 15

    Outcome Measure Data

    Analysis Population Description
    The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).
    Arm/Group Title Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo
    Arm/Group Description 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin
    Measure Participants 45 43 43 42
    Overall Score
    -9.3
    (23.6)
    -8.2
    (20.8)
    -8.9
    (20.1)
    -10.2
    (23.4)
    Ease of Defecation
    -6.2
    (32.8)
    -6.2
    (26.1)
    -5.9
    (26.2)
    -8.8
    (25.8)
    Feeling of Incomplete Bowel Evacuation
    -11.6
    (30.1)
    -10.9
    (31.5)
    -15.1
    (23.3)
    -9.5
    (34.0)
    Personal Judgement of Constipation
    -10.1
    (27.3)
    -7.5
    (24.3)
    -5.7
    (20.9)
    -12.4
    (27.6)
    5. Secondary Outcome
    Title Change in Adequate Relief of Constipation Symptoms From Baseline to Day 15
    Description Assessed using single question dichotomous tool. Adequate relief quantified the difference in the number of participants experiencing relief from constipation between participants supplemented with Litesse and those supplemented with a placebo at baseline and day 14. The units of analysis for the relief questionnaire were the number of participants who reported relief from constipation.
    Time Frame Baseline and Day 15

    Outcome Measure Data

    Analysis Population Description
    The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).
    Arm/Group Title Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo
    Arm/Group Description 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin
    Measure Participants 45 43 43 42
    Relief at Baseline
    24
    50%
    25
    52.1%
    19
    39.6%
    16
    33.3%
    Relief at Day 14 End-of-Study
    36
    75%
    31
    64.6%
    20
    41.7%
    26
    54.2%
    6. Secondary Outcome
    Title Change in Stool Frequency From Baseline to Day 15
    Description Participants will record the number of defecations per day in a daily diary
    Time Frame 14 day run-in and Week 2 of the 14-day supplementation period

    Outcome Measure Data

    Analysis Population Description
    The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).
    Arm/Group Title Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo
    Arm/Group Description 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin
    Measure Participants 45 43 43 42
    Mean (Standard Deviation) [Number of Bowel Movements Per Day]
    1.2
    (3.3)
    -0.2
    (3.3)
    -0.4
    (2.2)
    -0.9
    (3.7)
    7. Secondary Outcome
    Title Change in Stool Consistency From Baseline to Day 15
    Description Stool consistency will be rated each day in a diary by using the Bristol Stool Scale Form. Bristol Stool Scale: The BSS is a categorical scale ranging from 1 to 7 that interprets the consistency of a single bowel movement; a single score is recorded and used for analysis. Lower scores are associated with hard and lumpy consistencies while higher scores are associated with soft or liquid consistencies. Generally, an optimal BSS scores ranges from 3 to 5.
    Time Frame 14 day run-in and Week 2 of the 14-day supplementation period

    Outcome Measure Data

    Analysis Population Description
    The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).
    Arm/Group Title Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo
    Arm/Group Description 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin
    Measure Participants 45 43 43 42
    Mean (Standard Deviation) [scores on a scale]
    0.33
    (0.99)
    -0.11
    (0.95)
    0.30
    (0.99)
    0.13
    (0.93)
    8. Secondary Outcome
    Title Change in the Degree of Straining During Defecation From Baseline to Day 15
    Description Degree of straining for each bowel movement will be recorded in a daily diary using a 5-point scale. The degree of straining is a rating scale ranging from 1 (not at al) to 5 (an extreme amount) that interprets the degree to which an individual must strain during a unique defecation; a single core is recorded and used for analysis. Scores were calculated as the weekly average of the daily degree of straining (1-5) where a lower score represented less straining.
    Time Frame 14 day run-in and Week 2 of the 14-day supplementation period

    Outcome Measure Data

    Analysis Population Description
    The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).
    Arm/Group Title Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo
    Arm/Group Description 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin
    Measure Participants 45 43 43 42
    Mean (Standard Deviation) [scores on a scale]
    -0.07
    (0.82)
    -0.26
    (0.87)
    -0.15
    (0.81)
    -0.09
    (0.46)
    9. Secondary Outcome
    Title Change in the Sensation of Complete Bowel Emptying From Baseline to Day 15
    Description Sensation of complete bowel emptying for each bowel movement will be recorded in a daily diary on a dichotomous "yes" or "no" scale. The change in the sensation was defined as the change from baseline to week 2 in the percentage of complete bowel movements (CBMs) between participants supplemented with Litesse and those supplemented with a placebo. It assessed whether the participant felt as though their bowel movement was complete. The units of analysis for the sensation of complete bowel emptying was the weekly percentage of complete bowel movements, for each participant at run-in (week -1), week 1 and week 2.
    Time Frame 14 day run-in and Week 2 of the 14-day supplementation period

    Outcome Measure Data

    Analysis Population Description
    The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).
    Arm/Group Title Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo
    Arm/Group Description 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin
    Measure Participants 45 43 43 42
    Mean (Standard Deviation) [Percentage of CBMs per week]
    10.8
    (27.5)
    10.2
    (25.1)
    7.3
    (31.3)
    -3.4
    (33.2)
    10. Secondary Outcome
    Title Change in the Severity of Abdominal Discomfort From Baseline to Day 15
    Description Severity of abdominal discomfort will be recorded each day in a daily diary on a 5-point scale. The severity of abdominal discomfort was calculated from a rating scale ranging from 1 (not at all) to 5 very severe); a single score was recorded and used for analysis. Scores were calculated as the weekly average of the daily degree of discomfort where a lower score represented less straining.
    Time Frame 14 day run-in and Week 2 of the 14-day supplementation period

    Outcome Measure Data

    Analysis Population Description
    The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).
    Arm/Group Title Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo
    Arm/Group Description 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin
    Measure Participants 45 43 43 42
    Mean (Standard Deviation) [scores on a scale]
    0.06
    (0.57)
    -0.05
    (0.61)
    -0.10
    (0.58)
    -0.01
    (0.44)
    11. Secondary Outcome
    Title Change in the Bloating Severity From Baseline to Day 15
    Description Severity of bloating will be recorded each day in a daily diary on a 5-point scale. The severity of abdominal bloating was calculated from a rating scale ranging from 1 (not at all) to 5 very severe); a single score was recorded and used for analysis. Scores were calculated as the weekly average of the daily degree of bloating where a lower score represented less straining.
    Time Frame 14 day run-in and Week 2 of the 14-day supplementation period

    Outcome Measure Data

    Analysis Population Description
    The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).
    Arm/Group Title Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo
    Arm/Group Description 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin
    Measure Participants 45 43 43 42
    Mean (Standard Deviation) [scores on a scale]
    -0.13
    (0.58)
    -0.23
    (0.47)
    -0.12
    (0.49)
    -0.03
    (0.58)
    12. Secondary Outcome
    Title Overall Product Satisfaction
    Description Participants will be asked to rate their overall satisfaction with the study product's ability to relieve their constipation symptoms on a 5-point ordinal scale. The overall product satisfaction questionnaire consists of a single question that provides insight regarding the participants satisfaction on the product's ability to relieve constipation symptoms. The score that the participant indicates is considered the total score and no sub-scores are calculated. It is a rating scale that ranges from 1 (not at all satisfied) to 5 (very satisfied) where a higher score at the end-of-study indicates an improvement.
    Time Frame Assessed at Day 15 (end of study)

    Outcome Measure Data

    Analysis Population Description
    The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).
    Arm/Group Title Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo
    Arm/Group Description 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin
    Measure Participants 45 43 43 42
    Mean (Standard Deviation) [scores on a scale]
    3.26
    (1.20)
    3.09
    (1.23)
    2.54
    (1.14)
    2.62
    (1.15)
    13. Other Pre-specified Outcome
    Title Change in Hemoglobin Levels From Baseline to Day 15
    Description Safety will be evaluated by measuring whole blood hematology (specifically hemoglobin in this outcome).
    Time Frame Screening and Day 15 (end of study)

    Outcome Measure Data

    Analysis Population Description
    Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose).
    Arm/Group Title Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo
    Arm/Group Description 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin
    Measure Participants 47 48 47 48
    Mean (Standard Deviation) [g/dL]
    -1.0
    (5.1)
    -0.9
    (5.5)
    -1.4
    (5.1)
    0.3
    (5.7)
    14. Other Pre-specified Outcome
    Title Change in Hematocrit Levels From Screening to Day 15
    Description Safety will be evaluated by measuring the change in whole blood hematology (specifically hematocrit levels in this outcome).
    Time Frame Screening and Day 15 (end of study)

    Outcome Measure Data

    Analysis Population Description
    Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose).
    Arm/Group Title Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo
    Arm/Group Description 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin
    Measure Participants 47 48 47 48
    Mean (Standard Deviation) [Percentage of red blood cells]
    -0.0045
    (0.0156)
    -0.0008
    (0.0166)
    -0.0057
    (0.0141)
    0.0031
    (0.0146)
    15. Other Pre-specified Outcome
    Title Change in White Blood Cell Count From Baseline to Day 15
    Description Safety will be evaluated by measuring whole blood hematology (specifically white blood cell count in this outcome measure).
    Time Frame Screening and Day 15 (end of study)

    Outcome Measure Data

    Analysis Population Description
    Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose).
    Arm/Group Title Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo
    Arm/Group Description 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin
    Measure Participants 47 48 47 48
    Mean (Standard Deviation) [10^9 cells/L]
    0.13
    (1.56)
    -0.34
    (1.19)
    -0.19
    (1.24)
    0.06
    (1.33)
    16. Other Pre-specified Outcome
    Title Change in Red Blood Cell Count From Baseline to Day 15
    Description Safety will be evaluated by measuring whole blood hematology (specifically red blood cell count in this outcome measure).
    Time Frame Screening and Day 15 (end of study)

    Outcome Measure Data

    Analysis Population Description
    Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose).
    Arm/Group Title Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo
    Arm/Group Description 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin
    Measure Participants 47 48 47 48
    Mean (Standard Deviation) [10^12 cells/L]
    -0.052
    (0.157)
    -0.030
    (0.171)
    -0.053
    (0.163)
    0.034
    (0.159)
    17. Other Pre-specified Outcome
    Title Change in Mean Corpuscular Volume From Baseline to Day 15
    Description Safety will be evaluated by measuring whole blood hematology (specifically mean corpuscular volume in this outcome measure).
    Time Frame Screening and Day 15 (end of study)

    Outcome Measure Data

    Analysis Population Description
    Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose).
    Arm/Group Title Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo
    Arm/Group Description 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin
    Measure Participants 47 48 47 48
    Mean (Standard Deviation) [fL]
    0.10
    (1.13)
    0.23
    (1.09)
    -0.19
    (1.21)
    -0.09
    (1.05)
    18. Other Pre-specified Outcome
    Title Change in Mean Corpuscular Hemoglobin From Baseline to Day 15
    Description Safety will be evaluated by measuring whole blood hematology (specifically mean corpuscular hemoglobin in this outcome measure).
    Time Frame Screening and Day 15 (end of study)

    Outcome Measure Data

    Analysis Population Description
    Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose).
    Arm/Group Title Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo
    Arm/Group Description 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin
    Measure Participants 47 48 47 48
    Mean (Standard Deviation) [pg]
    0.16
    (0.75)
    -0.02
    (0.63)
    0.04
    (0.46)
    -0.15
    (0.54)
    19. Other Pre-specified Outcome
    Title Change in Mean Corpuscular Hemoglobin Concentration From Baseline to Day 15
    Description Safety will be evaluated by measuring whole blood hematology (specifically mean corpuscular hemoglobin concentration in this outcome measure).
    Time Frame Screening and Day 15 (end of study)

    Outcome Measure Data

    Analysis Population Description
    Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose).
    Arm/Group Title Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo
    Arm/Group Description 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin
    Measure Participants 47 48 47 48
    Mean (Standard Deviation) [g/dL]
    0.8
    (5.2)
    -0.9
    (5.9)
    1.4
    (4.7)
    -1.5
    (5.5)
    20. Other Pre-specified Outcome
    Title Change in Red Cell Distribution Width From Baseline to Day 15
    Description Safety will be evaluated by measuring whole blood hematology (specifically red cell distribution width in this outcome measure).
    Time Frame Screening and Day 15 (end of study)

    Outcome Measure Data

    Analysis Population Description
    Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose).
    Arm/Group Title Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo
    Arm/Group Description 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin
    Measure Participants 47 48 47 48
    Mean (Standard Deviation) [percent of mean red blood cell volume]
    -0.03
    (0.35)
    0.06
    (0.33)
    -0.03
    (0.62)
    -0.08
    (0.43)
    21. Other Pre-specified Outcome
    Title Change in Platelet Count From Baseline to Day 15
    Description Safety will be evaluated by measuring whole blood hematology (specifically platelet count in this outcome measure).
    Time Frame Screening and Day 15 (end of study)

    Outcome Measure Data

    Analysis Population Description
    Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose).
    Arm/Group Title Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo
    Arm/Group Description 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin
    Measure Participants 47 48 47 48
    Mean (Standard Deviation) [10^9 cells/L]
    -3.7
    (20.4)
    6.0
    (27.0)
    -5.9
    (25.9)
    1.6
    (29.5)
    22. Other Pre-specified Outcome
    Title Change in Neutrophil Count From Baseline to Day 15
    Description Safety will be evaluated by measuring whole blood hematology (specifically neutrophil count in this outcome measure).
    Time Frame Screening and Day 15 (end of study)

    Outcome Measure Data

    Analysis Population Description
    Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose).
    Arm/Group Title Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo
    Arm/Group Description 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin
    Measure Participants 47 48 47 48
    Mean (Standard Deviation) [10^9 cells/L]
    0.10
    (1.43)
    -0.19
    (1.00)
    -0.19
    (1.00)
    0.10
    (1.05)
    23. Other Pre-specified Outcome
    Title Change in Lymphocyte Count From Baseline to Day 15
    Description Safety will be evaluated by measuring whole blood hematology (specifically lymphocyte count in this outcome measure).
    Time Frame Screening and Day 15 (end of study)

    Outcome Measure Data

    Analysis Population Description
    Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose).
    Arm/Group Title Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo
    Arm/Group Description 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin
    Measure Participants 47 48 47 48
    Mean (Standard Deviation) [10^9 cells/L]
    0.04
    (0.44)
    -0.10
    (0.36)
    -0.01
    (0.39)
    -0.06
    (0.48)
    24. Other Pre-specified Outcome
    Title Change in Monocyte Count From Baseline to Day 15
    Description Safety will be evaluated by measuring whole blood hematology (specifically monocyte count in this outcome measure).
    Time Frame Screening and Day 15 (end of study)

    Outcome Measure Data

    Analysis Population Description
    Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose).
    Arm/Group Title Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo
    Arm/Group Description 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin
    Measure Participants 47 48 47 48
    Mean (Standard Deviation) [10^9 cells/L]
    -0.002
    (0.39)
    -0.012
    (0.13)
    -0.006
    (0.139)
    0.021
    (0.160)
    25. Other Pre-specified Outcome
    Title Change in Eosinophil Count From Baseline to Day 15
    Description Safety will be evaluated by measuring whole blood hematology (specifically eosinophil count in this outcome measure).
    Time Frame Screening and Day 15 (end of study)

    Outcome Measure Data

    Analysis Population Description
    Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose).
    Arm/Group Title Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo
    Arm/Group Description 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin
    Measure Participants 47 48 47 48
    Mean (Standard Deviation) [10^9 cells/L]
    -0.002
    (0.090)
    -0.025
    (0.076)
    0.030
    (0.197)
    0.029
    (0.153)
    26. Other Pre-specified Outcome
    Title Change in Basophil Count From Baseline to Day 15
    Description Safety will be evaluated by measuring whole blood hematology (specifically basophil count in this outcome measure).
    Time Frame Screening and Day 15 (end of study)

    Outcome Measure Data

    Analysis Population Description
    Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose).
    Arm/Group Title Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo
    Arm/Group Description 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin
    Measure Participants 47 48 47 48
    Mean (Standard Deviation) [10^9 cells/L]
    0.000
    (0.042)
    0.008
    (0.050)
    0.002
    (0.033)
    0.010
    (0.037)
    27. Other Pre-specified Outcome
    Title Change in Serum Glucose Concentration From Baseline to Day 15
    Description Safety will be evaluated by measuring blood serum variables (specifically glucose concentration in this outcome measure).
    Time Frame Screening and Day 15 (end of study)

    Outcome Measure Data

    Analysis Population Description
    The number analyzed from the Litesse powder 4g arm is only 47 due to laboratory analysis error.
    Arm/Group Title Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo
    Arm/Group Description 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin
    Measure Participants 48 48 47 48
    Mean (Standard Deviation) [mmol/L]
    -0.12
    (0.42)
    0.04
    (0.46)
    -0.15
    (0.44)
    -0.10
    (0.57)
    28. Other Pre-specified Outcome
    Title Change in Creatinine Levels in Blood From Baseline to Day 15
    Description Safety will be evaluated by measuring blood serum variables (specifically creatinine concentration in this outcome measure).
    Time Frame Screening and Day 15 (end of study)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo
    Arm/Group Description 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin
    Measure Participants 48 48 48 48
    Mean (Standard Deviation) [μmol]
    0.8
    (8.4)
    -0.1
    (5.9)
    0.6
    (4.8)
    0.8
    (5.4)
    29. Other Pre-specified Outcome
    Title Change in Serum Urea Concentration From Baseline to Day 15
    Description Safety will be evaluated by measuring blood serum variables (specifically urea concentration in this outcome measure).
    Time Frame Screening and Day 15 (end of study)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo
    Arm/Group Description 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin
    Measure Participants 48 48 48 48
    Mean (Standard Deviation) [mmol/L]
    0.18
    (1.11)
    -0.31
    (1.00)
    -0.10
    (1.03)
    0.08
    (1.20)
    30. Other Pre-specified Outcome
    Title Change in Serum Estimated Globular Filtration Rate From Baseline to Day 15
    Description Safety will be evaluated by measuring blood serum variables (specifically estimated glomerular filtration rate in this outcome measure).
    Time Frame Screening and Day 15 (end of study)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo
    Arm/Group Description 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin
    Measure Participants 48 48 48 48
    Mean (Standard Deviation) [mL/min/1.73m^2]
    -1.9
    (10.8)
    1.4
    (7.8)
    -0.1
    (5.6)
    -1.9
    (6.3)
    31. Other Pre-specified Outcome
    Title Change in Serum Sodium Concentration From Baseline to Day 15
    Description Safety will be evaluated by measuring blood serum variables (specifically sodium concentration in this outcome measure).
    Time Frame Screening and Day 15 (end of study)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo
    Arm/Group Description 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin
    Measure Participants 48 48 48 48
    Mean (Standard Deviation) [mmol/L]
    -0.90
    (2.94)
    -0.27
    (2.30)
    -0.83
    (2.60)
    -0.19
    (2.50)
    32. Other Pre-specified Outcome
    Title Change in Serum Potassium Concentration From Baseline to Day 15
    Description Safety will be evaluated by measuring blood serum variables (specifically potassium concentration in this outcome measure).
    Time Frame Screening and Day 15 (end of study)

    Outcome Measure Data

    Analysis Population Description
    One participant in the Litesse powder containing 4 g polydextrose arm did not have this blood serum variable analysed due to laboratory analysis error.
    Arm/Group Title Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo
    Arm/Group Description 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin
    Measure Participants 48 48 47 48
    Mean (Standard Deviation) [mmol/L]
    -0.21
    (0.53)
    -0.01
    (0.61)
    -0.21
    (0.50)
    -0.01
    (0.46)
    33. Other Pre-specified Outcome
    Title Change in Serum Chloride Concentration From Baseline to Day 15
    Description Safety will be evaluated by measuring blood serum variables (specifically chloride concentration in this outcome measure).
    Time Frame Screening and Day 15 (end of study)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo
    Arm/Group Description 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin
    Measure Participants 48 48 48 48
    Mean (Standard Deviation) [mmol/L]
    -0.21
    (2.32)
    -0.004
    (2.40)
    -0.71
    (2.08)
    -0.29
    (2.28)
    34. Other Pre-specified Outcome
    Title Change in Serum Calcium Concentration From Baseline to Day 15
    Description Safety will be evaluated by measuring blood serum variables (specifically calcium concentration in this outcome measure).
    Time Frame Screening and Day 15 (end of study)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo
    Arm/Group Description 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin
    Measure Participants 48 48 48 48
    Mean (Standard Deviation) [mmol/L]
    -0.019
    (0.101)
    0.016
    (0.092)
    -0.004
    (0.085)
    0.028
    (0.098)
    35. Other Pre-specified Outcome
    Title Change in Serum Carbon Dioxide Concentration From Baseline to Day 15
    Description Safety will be evaluated by measuring blood serum variables (specifically carbon dioxide concentration in this outcome measure).
    Time Frame Screening and Day 15 (end of study)

    Outcome Measure Data

    Analysis Population Description
    One participant in the Litesse powder containing 4 g polydextrose arm did not have this blood serum variable analysed due to laboratory analysis error.
    Arm/Group Title Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo
    Arm/Group Description 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin
    Measure Participants 48 48 47 48
    Mean (Standard Deviation) [mmol/L]
    -0.60
    (2.73)
    0.31
    (2.49)
    -0.13
    (2.65)
    -0.50
    (2.26)
    36. Other Pre-specified Outcome
    Title Change in Serum Phosphate Concentration From Baseline to Day 15
    Description Safety will be evaluated by measuring blood serum variables (specifically phosphate concentration in this outcome measure).
    Time Frame Screening and Day 15 (end of study)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo
    Arm/Group Description 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin
    Measure Participants 48 48 48 48
    Mean (Standard Deviation) [mmol/L]
    0.011
    (0.147)
    -0.034
    (0.165)
    0.012
    (0.168)
    -0.003
    (0.244)
    37. Other Pre-specified Outcome
    Title Change in Serum Bilirubin Concentration From Baseline to Day 15
    Description Safety will be evaluated by measuring blood serum variables (specifically bilirubin concentration in this outcome measure).
    Time Frame Screening and Day 15 (end of study)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo
    Arm/Group Description 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin
    Measure Participants 48 48 48 48
    Mean (Standard Deviation) [μmol/L]
    -0.5
    (4.0)
    0.6
    (3.3)
    0.1
    (3.4)
    0.6
    (5.0)
    38. Other Pre-specified Outcome
    Title Change in Serum Aspartate Transaminase Concentration From Baseline to Day 15
    Description Safety will be evaluated by measuring blood serum variables (specifically aspartate transaminase concentration in this outcome measure).
    Time Frame Screening and Day 15 (end of study)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo
    Arm/Group Description 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin
    Measure Participants 48 48 48 48
    Mean (Standard Deviation) [U/L]
    0.7
    (4.5)
    3.2
    (16.2)
    -0.1
    (7.8)
    0.2
    (4.9)
    39. Other Pre-specified Outcome
    Title Change in Serum Alanine Transaminase Concentration From Baseline to Day 15
    Description Safety will be evaluated by measuring blood serum variables (specifically alanine transaminase concentration in this outcome measure).
    Time Frame Screening and Day 15 (end of study)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo
    Arm/Group Description 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin
    Measure Participants 48 48 48 48
    Mean (Standard Deviation) [U/L]
    1.6
    (7.0)
    -0.1
    (7.7)
    -1.0
    (9.5)
    -0.6
    (8.2)
    40. Other Pre-specified Outcome
    Title Change in Serum Alkaline Phosphate Concentration From Baseline to Day 15
    Description Safety will be evaluated by measuring blood serum variables (specifically alkaline phosphate concentration in this outcome measure).
    Time Frame Screening and Day 15 (end of study)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo
    Arm/Group Description 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin
    Measure Participants 48 48 48 48
    Mean (Standard Deviation) [U/L]
    1.0
    (6.7)
    -0.7
    (7.7)
    -1.0
    (7.0)
    1.9
    (9.8)
    41. Other Pre-specified Outcome
    Title Change in Serum Gamma-Glutamyltransferase Concentration From Baseline to Day 15
    Description Safety will be evaluated by measuring blood serum variables (specifically gamma-glutamyltransferase concentration in this outcome measure).
    Time Frame Screening and Day 15 (end of study)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo
    Arm/Group Description 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin
    Measure Participants 48 48 48 48
    Mean (Standard Deviation) [U/L]
    0.6
    (4.0)
    -1.6
    (6.1)
    0.3
    (6.2)
    -2.8
    (15.3)
    42. Other Pre-specified Outcome
    Title Change in Serum C-Reactive Protein Concentration From Baseline to Day 15
    Description Safety will be evaluated by measuring blood serum variables (specifically C-reactive protein concentration in this outcome measure).
    Time Frame Screening and Day 15 (end of study)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo
    Arm/Group Description 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin
    Measure Participants 48 48 48 48
    Mean (Standard Deviation) [mg/L]
    0.6
    (2.6)
    0.1
    (4.4)
    -0.2
    (2.4)
    0.4
    (2.6)
    43. Other Pre-specified Outcome
    Title Change in Specific Gravity Urinalysis Parameter From Screening to Day 15
    Description Safety will be evaluated by measuring urine analyses (specifically specific gravity in this outcome measure). The reference range for specific gravity are 1.001 - 1.030 mmol/L, with no alerting or critical values.
    Time Frame Screening and Day 15 (end of study)

    Outcome Measure Data

    Analysis Population Description
    One participant from the 12 g polydextrose arm, one participant from the 8 g polydextrose arm, and three participants from the 4 g polydextrose arm were unable to have urinalysis parameters analysed.
    Arm/Group Title Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo
    Arm/Group Description 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin
    Measure Participants 47 47 45 48
    Mean (Standard Deviation) [mmol/L]
    0.0010
    (0.0072)
    0.0007
    (0.0071)
    0.0005
    (0.0135)
    0.0029
    (0.0096)
    44. Other Pre-specified Outcome
    Title Change in pH Urinalysis Parameter From Baseline to Day 15
    Description Safety will be evaluated by measuring urine analyses (specifically urine pH in this outcome measure). Urine pH reference range is between 5.0 - 8.0, with no alerting or critical values.
    Time Frame Screening and Day 15 (end of study)

    Outcome Measure Data

    Analysis Population Description
    One participant from the 12 g polydextrose arm, one participant from the 8 g polydextrose arm, and three participants from the 4 g polydextrose arm were unable to have urinalysis parameters analysed.
    Arm/Group Title Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo
    Arm/Group Description 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin
    Measure Participants 47 47 45 48
    Mean (Standard Deviation) [pH]
    -0.05
    (0.97)
    0.20
    (1.10)
    0.02
    (1.02)
    0.06
    (1.07)
    45. Other Pre-specified Outcome
    Title Number of Subjects With Adverse Events
    Description Adverse events were recorded in a daily diary during the 14-day run-in period and the 14-day treatment period. All types of adverse events as well as the total number of all adverse events reported were used in this outcome measure.
    Time Frame 14 days run-in and 14 days treatment

    Outcome Measure Data

    Analysis Population Description
    The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).
    Arm/Group Title Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo
    Arm/Group Description 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin
    Measure Participants 45 43 43 42
    Number [Number of Adverse Events]
    30
    23
    11
    29

    Adverse Events

    Time Frame Adverse events were reported between Day -14 to Day 14 (run-in and intervention periods).
    Adverse Event Reporting Description
    Arm/Group Title Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo
    Arm/Group Description 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin
    All Cause Mortality
    Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/48 (0%) 0/48 (0%) 0/48 (0%) 0/48 (0%)
    Other (Not Including Serious) Adverse Events
    Litesse Powder Containing 12 g Polydextrose Litesse Powder Containing 8 g Polydextrose Litesse Powder Containing 4 g Polydextrose Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 11/48 (22.9%) 10/48 (20.8%) 1/48 (2.1%) 11/48 (22.9%)
    Gastrointestinal disorders
    Nausea 1/48 (2.1%) 1 3/48 (6.3%) 3 0/48 (0%) 0 1/48 (2.1%) 2
    Abdominal Pain Upper 3/48 (6.3%) 3 2/48 (4.2%) 2 0/48 (0%) 0 1/48 (2.1%) 3
    Abdominal Distension 3/48 (6.3%) 3 1/48 (2.1%) 1 1/48 (2.1%) 1 3/48 (6.3%) 3
    Frequent Bowel Movements 0/48 (0%) 0 4/48 (8.3%) 4 0/48 (0%) 0 2/48 (4.2%) 2
    Nervous system disorders
    Headache 4/48 (8.3%) 4 3/48 (6.3%) 3 0/48 (0%) 0 4/48 (8.3%) 4

    Limitations/Caveats

    The study population was not sufficiently constipated at baseline.

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Tetyana Pelipyagina
    Organization KGK Synergize Inc.
    Phone 5194389374
    Email drtetyana@kgksynergize.com
    Responsible Party:
    KGK Science Inc.
    ClinicalTrials.gov Identifier:
    NCT02314936
    Other Study ID Numbers:
    • 01-2014
    First Posted:
    Dec 11, 2014
    Last Update Posted:
    Nov 9, 2018
    Last Verified:
    Apr 1, 2018