Effects of Resistant Potato Starch on the Gut Microbiota

Microbiota Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05242913
• Other study ID #: R10356
• Status: Completed
• Phase: N/A
• Start date: October 30, 2019
• Est. completion date: January 6, 2020

Study information

• Verified date: February 2022
• Source: Manitoba Starch Products
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: January 6, 2020
• Est. primary completion date: January 6, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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.

Related Conditions & MeSH terms

• Microbiota

Intervention

Dietary Supplement:
• Resistant Potato Starch
Unmodified potato starch containing >60% resistant starch Type 2
• Placebo
Fully digestible corn starch

Locations

Country	Name	City	State
Canada	Nutrasource Pharmaceutical and Nutraceutical Services	Guelph	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Manitoba Starch Products

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in relative abundance (% of gut microbiome) of Bifidobacterium from stool between treatment groups	Changes in relative abundance of Bifidobacterium after 4 weeks of consumption in High Dose, Low Dose, and placebo arms are compared.	Four weeks
Secondary	Changes in relative abundance (% of gut microbiome) of Bifidobacterium from stool between treatment groups	Changes in relative abundance of Bifidobacterium after 1 week of consumption in High Dose, Low Dose, and placebo arms are compared.	One week
Secondary	Changes in relative abundance (% of gut microbiome) of Bifidobacterium from stool within treatment groups	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
Secondary	Fecal SCFA (mmol/kg stool) changes from baseline	Between and within group comparisons of SCFA levels in stool for High Dose, Low Dose, and Placebo arms	One week, four weeks
Secondary	Changes from baseline in stool consistency using self-reported Bristol Stool Chart scores	Changes in constipation and diarrhea frequency in High Dose, Low Dose, and Placebo arms.	One week, four weeks
Secondary	Changes from baseline in gastrointestinal symptoms using the a modified Gastrointestinal Quality of Life Index scale	Changes in bloating, belching, abdominal pain, gas, and overall well-being in High Dose, Low Dose, and Placebo arms.	One week, four weeks