Effects of MSPrebiotic on Gut Health in the Elderly

NCT01977183 | Completed DMC

• 2 other identifiers: RRC/2013/1285B2013:016
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Focus of Study; Impact of MSPrebiotic on Gastrointestinal Microbiota

Keywords

gastrointestinal; microbiome; prebiotic; starch

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (1)

• Changes from baseline in overall health at 2, 6, 10 and 14 weeks

  2, 6, 10 and 14 weeks

Study Arms (4)

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.

Dietary Supplement: MSPrebiotic

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.

Dietary Supplement: Placebo

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.

Dietary Supplement: MSPrebiotic

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.

Dietary Supplement: Placebo

Interventions

MSPrebiotic DIETARY_SUPPLEMENT

Potato Resistant Starch

Also known as: Potato Resistant Starch

Elderly adults with MSPrebiotic; General adult population with MSPrebiotic

Placebo DIETARY_SUPPLEMENT

Placebo - Corn Starch

Elderly adults with Placebo; General adult population with Placebo

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Boniface Hospital: lead
• National Microbiology Laboratory, Canada: collaborator
• MSP Starch Products Inc.: collaborator

Study Sites (2)

St. Boniface Hosptial Research Centre

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Deer Lodge Centre

Winnipeg, Manitoba, R3J 0L3, Canada

Location

Related Publications (3)

• 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.

  PMID: 33303023 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.

  PMID: 29410955 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.

  PMID: 28410921 DERIVED

Study Officials

• Michelle J Alfa, PhD

  St. Boniface Hospital Research Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2013
• First Posted: November 6, 2013
• Study Start: September 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: June 1, 2016
• Last Updated: January 6, 2023

Record last verified: 2015-07

Locations

CA (2)