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

Manitoba Starch Products1 site in 1 country75 target enrollmentOctober 30, 2019

ConditionsMicrobiota

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Microbiota
Sponsor: Manitoba Starch Products
Enrollment: 75
Locations: 1
Primary Endpoint: Changes in relative abundance (% of gut microbiome) of Bifidobacterium from stool between treatment groups
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

October 30, 2019

End Date

January 6, 2020

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Manitoba Starch Products

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

Changes in relative abundance (% of gut microbiome) of Bifidobacterium from stool between treatment groups(One week)
Changes in relative abundance (% of gut microbiome) of Bifidobacterium from stool within treatment groups(One week, four weeks)
Fecal SCFA (mmol/kg stool) changes from baseline(One week, four weeks)
Changes from baseline in stool consistency using self-reported Bristol Stool Chart scores(One week, four weeks)
Changes from baseline in gastrointestinal symptoms using the a modified Gastrointestinal Quality of Life Index scale(One week, four weeks)