Effect of MSPrebiotic on Gastrointestinal Function and Blood Glucose Levels

NCT ID: NCT03910153

Last Updated: 2022-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-08
• Study Completion Date: 2019-10-07

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo - (Age 30-50 years)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

MSPrebiotic - (Age 30-50 years)

Group Type: EXPERIMENTAL

MSPrebiotic

Intervention Type: 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.

Placebo - (Aged 70 years and above)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

MSPrebiotic - (Aged 70 years and above)

Group Type: EXPERIMENTAL

MSPrebiotic

Intervention Type: 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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Source Nutraceutical, Inc.

INDUSTRY

Sponsor Role: collaborator

MSP Starch Products Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nalini Kaul, PhD

Role: PRINCIPAL_INVESTIGATOR

Source Nutraceutical, Inc.

Locations

Hill Top Research

Winnipeg, Manitoba, Canada

Countries

Canada

Other Identifiers

MSPCT2

Identifier Type: -

Identifier Source: org_study_id