Effects of Resistant Potato Starch on the Gut Microbiota

Not Applicable

Completed

• Conditions: Microbiota
• Interventions: Dietary Supplement: Resistant Potato Starch; Dietary Supplement: Placebo

• Registration Number: NCT05242913
• Lead Sponsor: Manitoba Starch Products

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-30
• Primary Completion: 2020-01-06
• Study Completion: 2020-01-06
• Study First Submitted: 2022-01-27
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-07
• Last Update Submitted: 2022-02-07
• Study First Posted: 2022-02-16
• Last Update Posted: 2022-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Dose SolnulTM	Resistant Potato Starch	7.0 g of Resistant Potato Starch administered daily for 4 weeks
Low Dose SolnulTM	Resistant Potato Starch	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
Placebo	Placebo	7.0 g digestible corn starch administered daily for 4 weeks

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Nutrasource Pharmaceutical and Nutraceutical Services; 🇨🇦 Guelph, Ontario, Canada