Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
84 participants
INTERVENTIONAL
2013-09-30
2016-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Elderly adults with MSPrebiotic
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.
MSPrebiotic
Potato Resistant Starch
Elderly adults with Placebo
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.
Placebo
Placebo - Corn Starch
General adult population with MSPrebiotic
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.
MSPrebiotic
Potato Resistant Starch
General adult population with Placebo
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.
Placebo
Placebo - Corn Starch
Interventions
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MSPrebiotic
Potato Resistant Starch
Placebo
Placebo - Corn Starch
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
30 Years
ALL
Yes
Sponsors
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National Microbiology Laboratory, Canada
OTHER
MSP Starch Products Inc.
INDUSTRY
St. Boniface Hospital
OTHER
Responsible Party
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Principal Investigators
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Michelle J Alfa, PhD
Role: PRINCIPAL_INVESTIGATOR
St. Boniface Hospital Research Centre
Locations
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St. Boniface Hosptial Research Centre
Winnipeg, Manitoba, Canada
Deer Lodge Centre
Winnipeg, Manitoba, Canada
Countries
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References
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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.
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.
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.
Other Identifiers
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B2013:016
Identifier Type: OTHER
Identifier Source: secondary_id
RRC/2013/1285
Identifier Type: -
Identifier Source: org_study_id
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