Effects of Resistant Potato Starch on the Gut Microbiota

February 7, 2022 updated by: Manitoba Starch Products

A Randomized Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Effects of Resistant Potato Starch (SolnulTM) on Intestinal Flora

This was a randomized, double-blind, three-arm, parallel group clinical trial, which assessed the shifts that occur in microbial populations after four weeks of supplementation with resistant potato starch (SolnulTM) at two different dosages, in comparison to a placebo in healthy adults.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

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
    • Ontario
      • Guelph, Ontario, Canada, N1G 0B4
        • Nutrasource Pharmaceutical and Nutraceutical Services

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

14 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI between 18.0 and 34.9 kg/square meter (inclusive) that were generally healthy as determined by medical history and screening blood work.

Exclusion Criteria:

  • Diagnosis of Irritable Bowel Syndrome (IBS), dyspepsia, significant gastrointestinal disorders, or other major diseases.

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: High Dose SolnulTM
7.0 g of Resistant Potato Starch administered daily for 4 weeks
Dietary supplement: Resistant Potato Starch
Unmodified potato starch containing >60% resistant starch Type 2
Other Names:
  • Solnul
  • MSPrebiotic
Active Comparator: Low Dose SolnulTM
3.5 g of Resistant Potato Starch (plus 3.5 g digestible corn starch for 7.0 g total carbohydrate) administered daily for 4 weeks
Dietary supplement: Resistant Potato Starch
Unmodified potato starch containing >60% resistant starch Type 2
Other Names:
  • Solnul
  • MSPrebiotic
Placebo Comparator: Placebo
7.0 g digestible corn starch administered daily for 4 weeks
Dietary supplement: Placebo
Fully digestible corn starch
Other Names:
  • AmiocaTM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in relative abundance (% of gut microbiome) of Bifidobacterium from stool between treatment groups
Time Frame: Four weeks
Changes in relative abundance of Bifidobacterium after 4 weeks of consumption in High Dose, Low Dose, and placebo arms are compared.
Four weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in relative abundance (% of gut microbiome) of Bifidobacterium from stool between treatment groups
Time Frame: One week
Changes in relative abundance of Bifidobacterium after 1 week of consumption in High Dose, Low Dose, and placebo arms are compared.
One week
Changes in relative abundance (% of gut microbiome) of Bifidobacterium from stool within treatment groups
Time Frame: One week, four weeks
Changes in relative abundance of Bifidobacterium between baseline and one or four week timepoints for High Dose, Low Dose, and Placebo arms.
One week, four weeks
Fecal SCFA (mmol/kg stool) changes from baseline
Time Frame: One week, four weeks
Between and within group comparisons of SCFA levels in stool for High Dose, Low Dose, and Placebo arms
One week, four weeks
Changes from baseline in stool consistency using self-reported Bristol Stool Chart scores
Time Frame: One week, four weeks
Changes in constipation and diarrhea frequency in High Dose, Low Dose, and Placebo arms.
One week, four weeks
Changes from baseline in gastrointestinal symptoms using the a modified Gastrointestinal Quality of Life Index scale
Time Frame: One week, four weeks
Changes in bloating, belching, abdominal pain, gas, and overall well-being in High Dose, Low Dose, and Placebo arms.
One week, four weeks

Collaborators and Investigators

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

Sponsor

Manitoba Starch Products

Investigators

  • Principal Investigator: Anthony Beir, MD, Nutrasource Pharmaceutical and Nutraceutical Services

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 (Actual)

October 30, 2019

Primary Completion (Actual)

January 6, 2020

Study Completion (Actual)

January 6, 2020

Study Registration Dates

First Submitted

January 27, 2022

First Submitted That Met QC Criteria

February 7, 2022

First Posted (Actual)

February 16, 2022

Study Record Updates

Last Update Posted (Actual)

February 16, 2022

Last Update Submitted That Met QC Criteria

February 7, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R10356

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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