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

NCT06949631 | Completed

• 1 other identifier: M03-25-01-T0081
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastrointestinal Microbiota

Keywords

Gastrointestinal; Microbiota; Gut; healthy adults

Outcome Measures

Primary Outcomes (1)

• To assess the shifts in Akkermansia genus in gut microbiota after 4 weeks of resistant potato starch (RPS) supplementation, compared to a placebo

  Change from baseline to Week 4 in the relative abundance of Akkermansia genus, as assessed via 16S ribosomal ribonucleic acid (rRNA) sequencing of fecal samples

  Week 4

Secondary Outcomes (7)

• To assess the shifts in Bifidobacterium genus in gut microbiota after 4 weeks of RPS supplementation, compared to a placebo

  Week 4

• To assess the effect of RPS on stool form (consistency) after 3 weeks of supplementation, compared to a placebo

  Week 4

• To assess the effect of RPS on stool form (consistency) after 3 weeks of supplementation, compared to a placebo

  Week 4

• To assess the effect of RPS on the number of bowel movements (BM) (stool frequency) after 3 weeks of supplementation, compared to a placebo

  Week 4

• To assess the effect of RPS on gastrointestinal (GI) symptoms after 4 weeks of supplementation, compared to a placebo

  Week 4

Other Outcomes (4)

• To assess the effect of RPS on leaky gut after 4 weeks of supplementation, compared to a placebo

  Week 4

• To assess the effect of RPS on systemic and gut microbial metabolomic biomarkers through metabolomic analyses of stool and serum samples after 4 weeks of supplementation, compared to a placebo

  Week 4

• To assess the effect of RPS on gut microbiota composition and determine the underlying genetic mechanisms through metagenomic analyses of stool samples after 4 weeks of supplementation, compared to a placebo

  Week 4

Study Arms (2)

Resistant Potato Starch

EXPERIMENTAL

Active: 1 sachet per day oral

Dietary Supplement: Resistant Potato Starch

Placebo

PLACEBO COMPARATOR

Placebo: 1 Sachet per day oral

Other: Placebo

Interventions

Resistant Potato Starch DIETARY_SUPPLEMENT

Active Ingredients: 3.5 g potato starch Inactive ingredients: 3.5 g corn starch

Resistant Potato Starch

Placebo OTHER

Active Ingredients: N/A Inactive Ingredients: 7 g corn starch

Placebo

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults who are 18 to 69 years of age (inclusive).
• Have a BMI between 18.0 to 34.9 kg/m2 (inclusive).
• In good general health (i.e., no uncontrolled diseases or conditions) as deemed by the investigator, medical history, screening bloodwork, and are able to consume the study product.
• Have maintained consistent dietary habits, including medication and supplement intake, and lifestyle for the last 3 months before screening and agree to maintain them throughout the study
• Agree to follow the restrictions on concomitant treatments
• Agree to follow the restrictions on lifestyle
• Agree to use acceptable contraceptive methods
• Willing and able to agree to the requirements of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures.

You may not qualify if:

• Individuals who are lactating, pregnant or planning to become pregnant during the study or demonstrate a positive pregnancy test at Visit 2.
• Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients.
• Individuals who have taken the TP at any time in the past, including having consumed products that list the TP as an ingredient.
• Have a family history of peptic ulcer, colorectal cancer, or IBD.
• Have structural or metabolic diseases/conditions that affect the GI system.
• Presence of concomitant conditions such as organic GI disease, lactose and/or gluten intolerance, proneness to rectal bleeding due to hemorrhoids, or persistent GI problems (e.g., chronic constipation or diarrhea) which, in the opinion of the investigator, may interfere with study outcomes or participant safety.
• Self-report of current or recovering acute GI problems at baseline (Visit 2).
• Current diagnosis of IBS, dyspepsia, and/or significant GI disorders.
• Screening alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP) results that are ≥ 2 times the upper limit of normal or any other clinically significant abnormal safety laboratory values as per the Investigator's discretion.
• On an unstable dose of medication (i.e., less than 90 days at the same dose level)
• Have Type I diabetes, uncontrolled Type II diabetes, uncontrolled high blood pressure (≥140 systolic or ≥90 diastolic mmHg), or uncontrolled thyroid disease ("uncontrolled" defined as being unmedicated, have an unstable use of medication within 3 months prior to screening, or have a stable use of medication for 3 months but still have uncontrolled conditions).
• Have medical condition(s) known to interfere with absorption, distribution, metabolism, or excretion of the study product (e.g., Crohn's disease, short bowel, acute or chronic pancreatitis, or pancreatic insufficiency).
• Have a history of heart/cardiovascular disease, renal disease (dialysis or renal failure), hepatic impairment/disease, immune disorders and/or immunocompromised (i.e., HIV/AIDS).
• Have a history of cancer (except localized skin cancer without metastases or in situ cervical cancer), unless recovery occurred more than 5 years before the screening visit.
• Are receiving treatments for or have been hospitalized in the last 12 months for psychiatric disorders (e.g., depression, bipolar disorder, schizophrenia, etc.).

Sponsors & Collaborators

• MSP Starch Products Inc.: lead
• Nutrasource Pharmaceutical and Nutraceutical Services, Inc.: collaborator

Study Sites (1)

Apex Trials

Guelph, Ontario/ON, N1G 0B4, Canada

Location

Study Officials

• Jason Bush, Chief Scientific Officer

  MSP Starch Products Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: April 29, 2025
• Study Start: May 29, 2025
• Primary Completion: October 3, 2025
• Study Completion: October 3, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)