Effects of MSPrebiotic on Gut Health in the Elderly

January 4, 2023 updated by: St. Boniface Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3J 0L3
        • Deer Lodge Centre
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • St. Boniface Hosptial Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Dietary supplement: MSPrebiotic
Potato Resistant Starch
Other Names:
  • Potato Resistant Starch
Placebo Comparator: 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.
Dietary supplement: Placebo
Placebo - Corn Starch
Experimental: 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.
Dietary supplement: MSPrebiotic
Potato Resistant Starch
Other Names:
  • Potato Resistant Starch
Placebo Comparator: 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.
Dietary supplement: Placebo
Placebo - Corn Starch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerability of 30g dose of MSPrebiotic
Time Frame: 2, 6, 10 and 14 weeks
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
Time Frame: 2, 6, 10 and 14 weeks
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
Time Frame: 2, 4, 6, 10 and 14 weeks
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
Time Frame: 2, 6, 10 and 14 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from baseline in overall health at 2, 6, 10 and 14 weeks
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Boniface Hospital

Collaborators

Manitoba Starch Products
National Microbiology Laboratory, Canada

Investigators

  • Principal Investigator: Michelle J Alfa, PhD, St. Boniface Hospital Research Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

October 11, 2013

First Submitted That Met QC Criteria

October 30, 2013

First Posted (Estimate)

November 6, 2013

Study Record Updates

Last Update Posted (Estimate)

January 6, 2023

Last Update Submitted That Met QC Criteria

January 4, 2023

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RRC/2013/1285
  • B2013:016 (Other Identifier: University of Manitoba Biomedical Reserach Ethics Board)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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