Effects of Resistant Potato Starch on the Gut Microbiota

MSP Starch Products Inc.75 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Microbiota

Interventions

Resistant Potato StarchDIETARY_SUPPLEMENT

Unmodified potato starch containing \>60% resistant starch Type 2

PlaceboDIETARY_SUPPLEMENT

Fully digestible corn starch

Eligibility

Sex: ALLMin age: 18 YearsMax age: 69 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Nutrasource Pharmaceutical and Nutraceutical Services

Guelph, Ontario, Canada

Outcomes

Primary Outcomes

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.

Time frame: Four weeks

Secondary Outcomes

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.

Time frame: One week

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.

Time frame: One week, four weeks

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

Time frame: One week, four weeks

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.

Time frame: One week, four weeks

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.

Time frame: One week, four weeks

Data from ClinicalTrials.gov

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