A Study to Assess the Gut Health Effects of Oil Compound on Healthy Adults
Study Details
Study Description
Brief Summary
The present study is a randomized, placebo-controlled, double-blind, parallel group study to assess the gut health effects of IP as compared to a placebo in normal, overweight and obese individuals experiencing gut issues. Approximately 94 will be randomized into 1:1 ratio to either receive IP or Placebo.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: C8-C12 5-15mL (one teaspoon to one tablespoon) once or twice a day. The participants will be dispensed a 5 ml pipette for consuming the IP |
Other: C8-C12
5-15mL (one teaspoon to one tablespoon) once or twice a day. The participants will be dispensed a 5 ml pipette for consuming the IP.
|
| Placebo Comparator: Placebo 5-15mL (one teaspoon to one tablespoon) once or twice a day. The participants will be dispensed a 5 ml pipette for consuming the IP |
Other: Placebo
5-15mL (one teaspoon to one tablespoon) once or twice a day. The participants will be dispensed a 5 ml pipette for consuming the IP.
|
Outcome Measures
Primary Outcome Measures
- To assess efficacy of the Investigational Product (IP) on [Day 56]
Gut permeability by assessing the levels of Lipopolysaccharide Binding Protein at day 56 from baseline.
Secondary Outcome Measures
- To assess the effect of the of IP on: [Day 0,1,2,3,4,5,28 and 56]
Daily energy levels using Visual Analogue Scale - Fatigue
- To assess the effect of the of IP on: [Day 0, 28 and 56]
Fatigue Severity Scale (FSS)
- To assess the effect of the of IP on: [Day 0, 28 and 56]
Immunomodulation using IFN-γ
- To assess the effect of the of IP on: [Day 0, 28 and 56]
Inflammation using TNF-α, IL-6 and IL-10
- To assess the effect of the of IP on: [Day 0, 28 and 56]
Stress as assessed by the change in the Perceived Stress Scale
- To assess the effect of the of IP on: [Day 0, 28 and 56]
Quality of life using Digestive Associated Quality of Life Questionnaire (DQLQ)
- To assess the effect of the of IP on: [Day 0, 28 and 56]
Satiety as assessed by the change in the Three-Factor Eating Questionnaire-R18 (TFEQ-R18)
- To assess the effect of the of IP on: [Day 0, 28 and 56]
Mood states using Mood and Feelings Questionnaire (MFQ)
- To assess the effect of the of IP on: [Day 0 and 56]
Clinical Responders as assessed by the number of participants achieving normal stool consistency using Bristol stool form scale (BSFS).
- To assess the effect of the of IP on: [Day 0 and 56]
Gut microbiome diversity using 16s RNA sequencing
Eligibility Criteria
Criteria
Inclusion Criteria:
- Male and female subjects with the age ≥18 and ≤60 years with active lifestyle, moderate physical activity level as per International Physical Activity Questionnaire
- Short Form (IPAQ-SF)
-
BMI of ≥ 18 - ≤ 34.9 kg/m2
-
Having at least three of the following five metabolic risk factors:
-
Waist circumference > 102 cm (40 inches) for men and > 88 cm (35 inches) for women;
-
Fasting triglycerides >150 mg/dL
-
Blood pressure ≥130 mm Hg (Systolic Blood Pressure) and/or ≥85 mm Hg (Diastolic Blood Pressure);
-
Fasting blood glucose ≥ 100 mg/ dl
-
Fasting HDL cholesterol level less than 40 mg/dl (men) or 50 mg/dl (women)
-
SGOT, SGPT ≤ 2 times the upper normal limit.
-
Creatinine levels ≤ 1.5 times the upper normal limit.
-
Willing to complete all study procedures including study related questionnaires and comply with study requirements.
-
Willing to abstain from other supplements or medication.
-
Ready to give voluntary, written, informed consent to participate in the study.
-
Evidence of abnormal stool consistency (at least one day every week indicating constipation or diarrhoea) as determined by Bristol Stool Scale in the last 3 months.
-
No self-reported physical/mental disabilities or gastrointestinal conditions.
-
No antibiotic usage within the last 30 days.
-
History of stable weight over the last 6 months (<10% change).
-
Willing to maintain current dietary and exercise habits, aside from any changes to be made per the study exercise protocol.
Exclusion Criteria:
-
Pure vegetarians who do not consume chicken, fish and/or egg.
-
Smokers
-
Presence of unstable, acutely symptomatic, or life-limiting illness.
-
Subjects with uncontrolled hypertension with systolic blood pressure ≥160 and diastolic blood pressure ≥100 mm Hg.
-
Subjects with uncontrolled Type II Diabetes Mellitus with FBG ≥ 126 mg/ dl
-
Neurological conditions causing functional or cognitive impairments.
-
Unwillingness or inability to be randomized to one of two intervention groups.
-
Bilateral hip replacements.
-
History or presence of clinically significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic or neurologic disorders that, in the judgment of the Investigator, would interfere with the participant's ability to provide informed consent, comply with the study protocol (which might confound the interpretation of the study results), or put the participant at undue risk.
-
History or presence of Irritable Bowel Syndrome as per Rome IV criteria. [Diagnostic criteria*
Recurrent abdominal pain on average at least 1 day/week in the last 3 months, associated with two or more of the following criteria:
- Related to defecation. 2. Associated with a change in frequency of stool. 3. Associated with a change in form (appearance) of stool.
- Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis]
-
Use of any psychotropic medication within four weeks of screening and throughout the study.
-
Use of antibiotics or signs of active systemic infection at the time of screening. Treatment visits will be rescheduled to the subject to wash off the antibiotic for at least five days prior to any test visit.
-
Subject states they regularly consume supplemental enzymes and are unwilling to stop at least one week prior to screening and throughout the study. Supplemental enzymes may include standalone enzyme supplements, probiotic supplements with enzymes, and any medications containing enzymes.
-
Subject states they regularly consume probiotic, prebiotic, energy and mood enhancing supplements supplements and are unwilling to stop at least one week prior to screening and throughout the study. Supplemental probiotics may include standalone probiotic supplements, vitamins with probiotics, and any foods supplemented with probiotics
-
Subject states they are currently being prescribed (by primary care physician or other health professional) medication or using an over-the-counter product that in the opinion of the study physician will have an effect on food digestion or nutrient absorption during the study.
-
Exposure to any non-registered drug product within 3 months prior to the screening visit.
-
Unable/unwillingness to complete study specific diaries (digital/paper-based).
-
Current use of the following medications: monoamine oxidase inhibitors, prescription or herbal weight loss medications/ dietary supplement.
-
Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
-
Heavy alcohol drinkers defined as follows: For men, consuming more than 4 drinks on any day or more than 14 drinks/week For women, consuming more than 3 drinks on any day or more than 7 drinks/week
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Apex Hospital | Ahmedabad | Gujarat | India | 380013 |
| 2 | Aman Hospital and Research Centre | Vadodara | Gujarat | India | 390021 |
| 3 | Hira Mongi Navneet Hospital | Mulund | Maharashtra | India | 400080 |
| 4 | Lifepoint Multispeciality Hospital | Pune | Maharashtra | India | 411057 |
Sponsors and Collaborators
- Vedic Lifesciences Pvt. Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- JR/220801/OC/GH