Effect of MSPrebiotic on Gastrointestinal Function and Blood Glucose Levels

Sponsor

Manitoba Starch Products (Industry)

Overall Status

Completed

CT.gov ID

NCT03910153

Collaborator

Source Nutraceutical, Inc. (Industry)

110

Enrollment

Location

Arms

Actual Duration (Months)

18.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of the study is to investigate the impact of daily consumption of MSPrebiotic at a dosage level of 30 g per day for 12 weeks on gastrointestinal microbiota in the elderly (> 70 years age) and another age group (30 to 50 years). In addition, impact of MSPrebiotic on short chain fatty acids, glucose and insulin levels as well as metabolomic changes will also be studied. A randomized, double-blinded study will be conducted to assess the health benefits of MSPrebiotic and compared with a placebo. This study will provide substantiation for a beneficial effect of MSPrebiotic resistant starch on gut microbiome.

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Function	Dietary Supplement: MSPrebiotic Other: Placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

110 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effect of MSPrebiotic Digestion Resistant Starch on Gastrointestinal Function and Blood Glucose Levels

Actual Study Start Date :

Apr 8, 2019

Actual Primary Completion Date :

Oct 7, 2019

Actual Study Completion Date :

Oct 7, 2019

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo - (Age 30-50 years)	Other: Placebo Corn starch (30 g) will be mixed in 1 glass (approximately 250 mL) of non-heated fluid or non-heated semi solid food and consumed. If the subject is on any medications, the corn starch will be administered either 2 hours before medications or 2 hours after participants have taken their medications.
Experimental: MSPrebiotic - (Age 30-50 years)	Dietary Supplement: MSPrebiotic MSPrebiotic digestion resistant starch from potatoes (30 g) will be mixed in 1 glass (approximately 250 mL) of non-heated fluid or non-heated semi solid food and consumed. If the subject is on any medications, the potato resistant starch will be administered either 2 hours before medications or 2 hours after participants have taken their medications.
Placebo Comparator: Placebo - (Aged 70 years and above)	Other: Placebo Corn starch (30 g) will be mixed in 1 glass (approximately 250 mL) of non-heated fluid or non-heated semi solid food and consumed. If the subject is on any medications, the corn starch will be administered either 2 hours before medications or 2 hours after participants have taken their medications.
Experimental: MSPrebiotic - (Aged 70 years and above)	Dietary Supplement: MSPrebiotic MSPrebiotic digestion resistant starch from potatoes (30 g) will be mixed in 1 glass (approximately 250 mL) of non-heated fluid or non-heated semi solid food and consumed. If the subject is on any medications, the potato resistant starch will be administered either 2 hours before medications or 2 hours after participants have taken their medications.

Outcome Measures

Primary Outcome Measures

Changes from baseline in gut microbiome [0 and 14 weeks]
Gut microbiome composition (ratio between number of Firmicutes and Bacteroides) will be measured using 16S ribosomal ribonucleic acid (rRNA) gene sequencing in stool samples
Changes from baseline in concentration of short chain fatty acids in stool samples [0 and 14 weeks]
Concentration of short chain fatty acids (acetate, propionate, butyrate, isobutyrate, valerate,isovalerate) in feces will be measured using gas chromatographic method
Changes from baseline in bowel movements with respect to number of bowel movements and stool consistency [0, 2, 6,10 and 14 weeks]
Number of bowel movements will be measured using questionnaire. Stool consistency will be measured using questionnaires recording Bristol score. Bristol stool chart indicates the following types: Type 1-Separate hard lumps, like nuts; Type 2-Sausage-shaped but lumpy; Type 3-Like a sausage but with cracks on its surface; Type 4-Like a sausage or snake, smooth and soft; Type 5-Soft blobs with clear-cut edges (passed easily); Type 6-Fluffy pieces with ragged edges, a mushy stool; Type 7-Watery, no solid pieces. Entirely liquid.
Changes from baseline in blood glucose concentrations [0, 2, 6,10 and 14 weeks]
Blood glucose levels concentrations will be measured using standard laboratory methods
Changes from baseline in blood insulin concentrations [0 and 14 weeks]
Blood insulin concentrations will be measured using standard laboratory methods

Secondary Outcome Measures

Changes from baseline in tolerability in terms of excessive flatulence, abdominal pain, and bloating: questionnaires [0, 2, 6,10 and 14 weeks]
Tolerability of consuming MSPrebiotic in terms of excessive flatulence, abdominal pain, and bloating will be measured using questionnaires. The questionnaire will record the severity of flatulence, abdominal pain and bloating on a scale of 1 to 5 where 1=none and 5=extreme.
Changes from baseline in overall health in terms of outpatient visits and hospitalizations [0, 2, 6,10 and 14 weeks]
Overall health will be measured using questionnaires on outpatient visits and hospitalizations. The questionnaire contains Yes/No question to record if the subject had any outpatient visits or hospitalizations.
Changes from baseline in concentration of blood lipids and C-reactive protein Inflammatory marker C-reactive protein. Metabolomic changes [0 and14 weeks]
Concentration of blood lipids and C-reactive protein will be measured using standard laboratory methods.
Changes from baseline in concentration of blood and fecal Metabolomics [0 and 14 weeks]
Concentration of blood and fecal metabolomics will be measured using reverse phase liquid chromatography quadrupole time of flight tandem mass spectroscopy (RPLC-QTOF-MS/MS)

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Ability to provide written informed consent (or by the authorized 3rd party).
Willing to provide stool (2 times) and blood (6 times) samples over the 14 week study period
Subjects between 30-50 and above 70 years of age
Subjects willing to provide fasting blood during Screening and weeks 0, 2, 6, 10 and 14 visits
Female subjects not pregnant or breast feeding
Female subjects not planning for pregnancy during the study period

Exclusion Criteria:

Crohn's disease or any other inflammatory bowel disease
Individuals with Lupus, or on cancer chemotherapy
Pre-diabetes or Diabetes
Thyroid disease
Renal disease
Hepatic disease
Previous gastrointestinal surgery (intestinal resection, gastric bypass, colorectal surgery)
Subjects on probiotic (e.g. yoghurt),
Subjects on antibiotics at time of recruitment or on antibiotics within the previous five weeks
Individuals experiencing dysphagia
Subjects using additional fiber supplements
Subjects on digestants, emetics and antiemetics, medications for acid peptic disease and antacids.
Subjects allergic to potato or corn
Have conditions, factors, medication (other than those listed above) that the Investigator believes may affect the response of the gut or the interpretation of the test results