Effect of MSPrebiotic on Gastrointestinal Function and Blood Glucose Levels

NCT03910153 | Completed

• 1 other identifier: MSPCT2
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Function

Keywords

Prebiotic; Potato Starch; Resistant Starch; MSPrebiotic; Gut Health; Microbiome; Glucose

Outcome Measures

Primary Outcomes (5)

• Changes from baseline in gut microbiome

  Gut microbiome composition (ratio between number of Firmicutes and Bacteroides) will be measured using 16S ribosomal ribonucleic acid (rRNA) gene sequencing in stool samples

  0 and 14 weeks

• Changes from baseline in concentration of short chain fatty acids in stool samples

  Concentration of short chain fatty acids (acetate, propionate, butyrate, isobutyrate, valerate,isovalerate) in feces will be measured using gas chromatographic method

  0 and 14 weeks

• Changes from baseline in bowel movements with respect to number of bowel movements and stool consistency

  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.

  0, 2, 6,10 and 14 weeks

• Changes from baseline in blood glucose concentrations

  Blood glucose levels concentrations will be measured using standard laboratory methods

  0, 2, 6,10 and 14 weeks

• Changes from baseline in blood insulin concentrations

  Blood insulin concentrations will be measured using standard laboratory methods

  0 and 14 weeks

Secondary Outcomes (4)

• Changes from baseline in tolerability in terms of excessive flatulence, abdominal pain, and bloating: questionnaires

  0, 2, 6,10 and 14 weeks

• Changes from baseline in overall health in terms of outpatient visits and hospitalizations

  0, 2, 6,10 and 14 weeks

• Changes from baseline in concentration of blood lipids and C-reactive protein Inflammatory marker C-reactive protein. Metabolomic changes

  0 and14 weeks

• Changes from baseline in concentration of blood and fecal Metabolomics

  0 and 14 weeks

Study Arms (4)

Placebo - (Age 30-50 years)

PLACEBO COMPARATOR

Other: Placebo

MSPrebiotic - (Age 30-50 years)

EXPERIMENTAL

Dietary Supplement: MSPrebiotic

Placebo - (Aged 70 years and above)

PLACEBO COMPARATOR

Other: Placebo

MSPrebiotic - (Aged 70 years and above)

EXPERIMENTAL

Dietary Supplement: MSPrebiotic

Interventions

MSPrebiotic DIETARY_SUPPLEMENT

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.

MSPrebiotic - (Age 30-50 years); MSPrebiotic - (Aged 70 years and above)

Placebo OTHER

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.

Placebo - (Age 30-50 years); Placebo - (Aged 70 years and above)

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MSP Starch Products Inc.: lead
• Source Nutraceutical, Inc.: collaborator

Study Sites (1)

Hill Top Research

Winnipeg, Manitoba, R3L 2W2, Canada

Location

Study Officials

• Nalini Kaul, PhD

  Source Nutraceutical, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: April 10, 2019
• Study Start: April 8, 2019
• Primary Completion: October 7, 2019
• Study Completion: October 7, 2019
• Last Updated: January 25, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)