Focus of Study; Impact of MSPrebiotic on Gastrointestinal Microbiota Clinical Trial
Official title:
Effects of MSPrebiotic on Gut Health in the Elderly
| Verified date | July 2015 |
| Source | St. Boniface Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this clinical trial is to study the effects of potato resistant starch on the microbiota (microorganisms or bacteria) and short chain fatty acids levels of the gut. Levels will be measured and compared between elderly adults and in pre-elderly, adults from the general public. A correlation between the use of potato resistant starch and specific clinical and quality of life endpoints between elderly adults and in pre-elderly, adults from the general public will be studied. Hypothesis 1: The investigator hypothesizes that the microbiome in elderly adults (≥70 years) is less diverse and more prone to imbalance compared to adults (30-50 years) from the general population and that this imbalance of the gut microflora in the elderly adults is partially related to inadequate RS in their diet. Hypothesis 2: The investigator hypothesizes that ingestion of potato resistant starch of food grade quality (MSPrebiotic) will stabilize the gut microbiome (i.e. high Firmicutes/Bacteroides ratio)in LTC residents (i.e. similar to that of adults from the general population), thereby improving gut health and reducing the risk of diarrhea and/or gut infection.
| Status | Completed |
| Enrollment | 84 |
| Est. completion date | June 2016 |
| Est. primary completion date | January 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 30 Years and older |
| Eligibility | Inclusion Criteria: - Ability to provide written informed consent - Willing to provide stool and blood specimens 5 times over the 14 week study period - Subjects = 70 years of age - Subjects 30-50 years of age Exclusion Criteria: - Pregnancy - 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 - 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. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Deer Lodge Centre | Winnipeg | Manitoba |
| Canada | St. Boniface Hosptial Research Centre | Winnipeg | Manitoba |
| Lead Sponsor | Collaborator |
|---|---|
| St. Boniface Hospital | Manitoba Starch Products, National Microbiology Laboratory, Canada |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Tolerability of 30g dose of MSPrebiotic | Changes from baseline in the tolerability of ingestion of 30 g once/day of MSPrebiotic with respect to gastrointestinal side effects (excessive flatulence, changes in bowel movements, abdominal pain and bloating) at 2, 6, 10 and 14 weeks. | 2, 6, 10 and 14 weeks | |
| Primary | Gut health improvements | Changes from baseline in gut health improvements including: reduced constipation (i.e. improved ease of bowel movements without stool softeners), microbiome composition (i.e. favourable Firmicutes to Bacteroides ratio) at 2, 6, 10 and 14 weeks. | 2, 6, 10 and 14 weeks | |
| Primary | Levels of short chain fatty acids in stool and lipid level in blood | Changes from baseline of short chain fatty acid levels in stool including; acetate, propionate, butyrate, isobutyrate, valerate, isovalerate at 2, 4, 6, 10 and 14 weeks. | 2, 4, 6, 10 and 14 weeks | |
| Primary | Inflammatory marker | Changes from baseline of Inflammatory marker (IL-10, C-reactive protein, TNFa) levels in blood at 2, 6, 10 and 14 weeks. | 2, 6, 10 and 14 weeks | |
| Secondary | Changes from baseline in overall health at 2, 6, 10 and 14 weeks | This will be assessed based on completion of a daily health log that assesses a wide variety of parameters. | 2, 6, 10 and 14 weeks |