Effect of MSPrebiotic on Gastrointestinal Function and Blood Glucose Levels

Manitoba Starch Products

Status: Completed

Conditions: Gastrointestinal Function

Treatments: Dietary Supplement: MSPrebiotic; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03910153

MSPCT2

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: All

Ages: 30+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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110 participants in 4 patient groups, including a placebo group

Placebo - (Age 30-50 years)

Placebo Comparator group

Treatment:

Other: Placebo

MSPrebiotic - (Age 30-50 years)

Experimental group

Treatment:

Dietary Supplement: MSPrebiotic

Placebo - (Aged 70 years and above)

Placebo Comparator group

Treatment:

Other: Placebo

MSPrebiotic - (Aged 70 years and above)

Experimental group

Treatment:

Dietary Supplement: MSPrebiotic