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| ID | Type | Description | Link |
|---|---|---|---|
| B2013:016 | Other Identifier | University of Manitoba Biomedical Reserach Ethics Board |
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| Name | Class |
|---|---|
| National Microbiology Laboratory, Canada | OTHER |
| MSP Starch Products Inc. | INDUSTRY |
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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.
To assess the impact on the potato resistant starch on the microbiota, pyrosequencing will be performed on stool samples to determine the original composition and assess any changes over the study period. In addition the impact of the potato resistant starch on inflammatory markers will be assess through blood samples collected over the study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elderly adults with MSPrebiotic | Experimental | 30 g of MSPrebiotic (potato resistant starch) per day taken with 1 glass (approximately 250 mL) of non-heated fluid or non-heated semi-solid food. If the participant is taking any medications, they will be advised to either take the product 2 hours before or 2 hours after any medications. |
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| Elderly adults with Placebo | Placebo Comparator | 30 g of corn starch per day taken with 1 glass (approximately 250 mL) of non-heated fluid or or non-heated semi-solid food. If the participant is taking any medications, they will be advised to either take the product 2 hours before or 2 hours after any medications. |
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| General adult population with MSPrebiotic | Experimental | 30 g of MSPrebiotic (potato resistant starch) per day taken with 1 glass (approximately 250 mL) of non-heated fluid. If the participant is taking any medications, they will be advised to either take the product 2 hours before or 2 hours after any medications. |
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| General adult population with Placebo | Placebo Comparator | 30 g of corn starch per day taken with 1 glass (approximately 250 mL) of non-heated fluid. If the participant is taking any medications, they will be advised to either take the product 2 hours before or 2 hours after any medications. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MSPrebiotic | Dietary Supplement | Potato Resistant Starch |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Inflammatory marker | Changes from baseline of Inflammatory marker (IL-10, C-reactive protein, TNFα) levels in blood at 2, 6, 10 and 14 weeks. | 2, 6, 10 and 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle J Alfa, PhD | St. Boniface Hospital Research Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Boniface Hosptial Research Centre | Winnipeg | Manitoba | R2H 2A6 | Canada | ||
| Deer Lodge Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33303023 | Derived | Bush JR, Alfa MJ. Increasing levels of Parasutterella in the gut microbiome correlate with improving low-density lipoprotein levels in healthy adults consuming resistant potato starch during a randomised trial. BMC Nutr. 2020 Dec 11;6(1):72. doi: 10.1186/s40795-020-00398-9. | |
| 29410955 | Derived | Alfa MJ, Strang D, Tappia PS, Olson N, DeGagne P, Bray D, Murray BL, Hiebert B. A Randomized Placebo Controlled Clinical Trial to Determine the Impact of Digestion Resistant Starch MSPrebiotic(R) on Glucose, Insulin, and Insulin Resistance in Elderly and Mid-Age Adults. Front Med (Lausanne). 2018 Jan 22;4:260. doi: 10.3389/fmed.2017.00260. eCollection 2017. |
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| Placebo | Dietary Supplement | Placebo - Corn Starch |
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| Winnipeg |
| Manitoba |
| R3J 0L3 |
| Canada |
| 28410921 | Derived | Alfa MJ, Strang D, Tappia PS, Graham M, Van Domselaar G, Forbes JD, Laminman V, Olson N, DeGagne P, Bray D, Murray BL, Dufault B, Lix LM. A randomized trial to determine the impact of a digestion resistant starch composition on the gut microbiome in older and mid-age adults. Clin Nutr. 2018 Jun;37(3):797-807. doi: 10.1016/j.clnu.2017.03.025. Epub 2017 Mar 31. |