Clinical trial NCT03910153: Effect of MSPrebiotic on Gastrointestinal Function and Blood Glucose Levels
Official title: Effect of MSPrebiotic Digestion Resistant Starch on Gastrointestinal Function and Blood Glucose Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Function
Keywords: Prebiotic
Potato Starch
Resistant Starch
MSPrebiotic
Gut Health
Microbiome
Glucose
Lead sponsor: MSP Starch Products Inc.
Sponsor class: INDUSTRY
Collaborators: name: Source Nutraceutical, Inc.
First posted: 2019-04-10
Enrollment: 110
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Changes from baseline in gut microbiome
timeFrame: 0 and 14 weeks
measure: Changes from baseline in concentration of short chain fatty acids in stool samples
timeFrame: 0 and 14 weeks
measure: Changes from baseline in bowel movements with respect to number of bowel movements and stool consistency
timeFrame: 0, 2, 6,10 and 14 weeks
measure: Changes from baseline in blood glucose concentrations
timeFrame: 0, 2, 6,10 and 14 weeks
measure: Changes from baseline in blood insulin concentrations
timeFrame: 0 and 14 weeks
Secondary outcomes:
measure: Changes from baseline in tolerability in terms of excessive flatulence, abdominal pain, and bloating: questionnaires
timeFrame: 0, 2, 6,10 and 14 weeks
measure: Changes from baseline in overall health in terms of outpatient visits and hospitalizations
timeFrame: 0, 2, 6,10 and 14 weeks
measure: Changes from baseline in concentration of blood lipids and C-reactive protein Inflammatory marker C-reactive protein. Metabolomic changes
timeFrame: 0 and14 weeks
measure: Changes from baseline in concentration of blood and fecal Metabolomics
timeFrame: 0 and 14 weeks
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Hill Top Research
state: Manitoba
Study officials:
affiliation: Source Nutraceutical, Inc.
name: Nalini Kaul, PhD
role: PRINCIPAL_INVESTIGATOR
References: