NCT06949631

Study on the Effects of Resistant Potato Starch on Gut Bacteria in Healthy Adults

A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Effects of Resistant Potato Starch on the Gut Microbiota Composition in Healthy Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: MSP Starch Products Inc. · Industry
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to evaluate how taking Resistant Potato Starch affects the gut microbiota compared to a placebo, in healthy adults. Over a 4-week period, participants will provide stool samples for analysis to detect any changes in gut bacteria. They will also record daily information in a diary about their stool consistency, frequency, digestive symptoms, and overall quality of life.

Detailed description

This is a randomized, double-blind, placebo-controlled study designed to evaluate the effects of a low dose of Resistant Potato Starch on the gut microbiome in healthy adults. The test product is a type of resistant starch derived from potatoes, which may help strengthen the gut barrier and improve microbiome balance by acting as a prebiotic that supports healthy gut bacteria. The main goal of the study is to measure changes in the gut microbiota after 4 weeks of taking the resistant starch compared to a placebo. Secondary goals include assessing changes in stool consistency, bowel movement frequency, digestive symptoms, and overall quality of life, also after 4 weeks of supplementation. Before starting the study, participants will go through a short run-in period where they will complete a daily diary to track their stool form and frequency, general health changes, and any other medications they are taking. The study will enroll generally healthy adults to specifically examine the effect of the resistant starch on levels of \*Akkermansia\*, a beneficial type of gut bacteria. People will be excluded from the study if they have taken the test product before, have a family history of gastrointestinal diseases, have used antibiotics within 5 weeks before or during the study, have existing gastrointestinal conditions, or have lactose and/or gluten intolerance. Anyone who, in the opinion of the Principal Investigator, may not be a good fit for the study or whose participation may pose a risk to their health will also be excluded.

Conditions

• Gastrointestinal Microbiota

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Resistant Potato Starch	Active Ingredients: 3.5 g potato starch Inactive ingredients: 3.5 g corn starch
OTHER	Placebo	Active Ingredients: N/A Inactive Ingredients: 7 g corn starch

Timeline

• Start date: 2025-05-29
• Primary completion: 2025-10-03
• Completion: 2025-10-03
• First posted: 2025-04-29
• Last updated: 2025-11-20

Locations

1 site across 1 country: Canada