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

This study tests if eating resistant potato starch can change the gut bacteria in healthy adults.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 74 (estimated)
• Ages: 18 Years to 69 Years
• Sex: All
• Sponsor: MSP Starch Products Inc. (Industry-sponsored)
• Locations: 1 site (Guelph, Ontario/ON)
• Trial ID: NCT06949631 on ClinicalTrials.gov

What this trial studies

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Who should consider this trial

Good fit: Unknown

Not a fit: Unknown

Why it matters

Potential benefit: Unknown

How similar studies have performed: Unknown

Eligibility criteria

Inclusion Criteria:

1. Adults who are 18 to 69 years of age (inclusive).
2. Have a BMI between 18.0 to 34.9 kg/m2 (inclusive).
3. 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.
4. 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
5. Agree to follow the restrictions on concomitant treatments
6. Agree to follow the restrictions on lifestyle
7. Agree to use acceptable contraceptive methods
8. 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.

Exclusion Criteria:

1. Individuals who are lactating, pregnant or planning to become pregnant during the study or demonstrate a positive pregnancy test at Visit 2.
2. Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients.
3. Individuals who have taken the TP at any time in the past, including having consumed products that list the TP as an ingredient.
4. Have a family history of peptic ulcer, colorectal cancer, or IBD.
5. Have structural or metabolic diseases/conditions that affect the GI system.
6. 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.
7. Self-report of current or recovering acute GI problems at baseline (Visit 2).
8. Current diagnosis of IBS, dyspepsia, and/or significant GI disorders.
9. 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.
10. On an unstable dose of medication (i.e., less than 90 days at the same dose level)
11. 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).
12. 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).
13. 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).
14. 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.
15. Are receiving treatments for or have been hospitalized in the last 12 months for psychiatric disorders (e.g., depression, bipolar disorder, schizophrenia, etc.).
16. Reports a clinically significant illness during the 28 days before the first dose of study product.
17. Major surgery in 3 months prior to screening or planned major surgery during the study.
18. Have a history of alcohol or substance abuse in the 12 months prior to screening (including having been hospitalized for such in an in-patient or out-patient intervention program) or use that in the opinion of the investigator may be of a concern for the study.
19. Current enrollment or past participation in another study with any product(s) with at least one active ingredient within 28 days before screening or longer, if the previous test product is deemed by the investigator to have lasting effects that might influence the eligibility criteria or outcomes of current study.
20. Any other medical condition/situation or use of medications/supplements/ therapies that, in the opinion of the investigator, may adversely affect the participant's ability to participate in the study or its measures or pose a significant risk to the participant.

Where this trial is running

Guelph, Ontario/ON

• Apex Trials — Guelph, Ontario/ON, Canada (Recruiting)

Study contacts

• Study coordinator: Bisma Sharif, MD

Conditions Gastrointestinal Microbiota; Gastrointestinal; Microbiota; Gut; healthy adults