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Completed

NCT Number: NCT05242913

Effects of Resistant Potato Starch on the Gut Microbiota

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.

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Key information

Conditions

Microbiota Abdominal Pain Carbohydrate Metabolism, Inborn Errors Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Constipation Diarrhea Genetic Diseases, Inborn Lysosomal Storage Diseases Metabolic Diseases Metabolism, Inborn Errors Mucinoses Mucopolysaccharidoses Mucopolysaccharidosis IV Neurologic Manifestations Nutritional and Metabolic Diseases Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Skin and Connective Tissue Diseases

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nutrasource Pharmaceutical and Nutraceutical Services

Guelph, Ontario, N1G 0B4, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Resistant Potato Starch

Dietary Supplement

Unmodified potato starch containing >60% resistant starch Type 2

Other names: Solnul, MSPrebiotic

Placebo

Dietary Supplement

Fully digestible corn starch

Other names: AmiocaTM

Primary outcomes

  1. 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

  1. Changes in relative abundance (% of gut microbiome) of Bifidobacterium from stool between treatment groups

    Time frame: One week

    Changes in relative abundance of Bifidobacterium after 1 week of consumption in High Dose, Low Dose, and placebo arms are compared.

  2. Changes in relative abundance (% of gut microbiome) of Bifidobacterium from stool within treatment groups

    Time frame: 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.

  3. Fecal SCFA (mmol/kg stool) changes from baseline

    Time frame: One week, four weeks

    Between and within group comparisons of SCFA levels in stool for High Dose, Low Dose, and Placebo arms

  4. Changes from baseline in stool consistency using self-reported Bristol Stool Chart scores

    Time frame: One week, four weeks

    Changes in constipation and diarrhea frequency in High Dose, Low Dose, and Placebo arms.

  5. Changes from baseline in gastrointestinal symptoms using the a modified Gastrointestinal Quality of Life Index scale

    Time frame: One week, four weeks

    Changes in bloating, belching, abdominal pain, gas, and overall well-being in High Dose, Low Dose, and Placebo arms.

Sponsors and collaborators

Lead sponsor

MSP Starch Products Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 16, 2022
Registry last updated
Feb 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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