Gastrointestinal MicrobiotaNCT06949631
Study on the Effects of Resistant Potato Starch on Gut Bacteria in Healthy Adults
A study testing Resistant Potato Starch in people with Gastrointestinal Microbiota, run by MSP Starch Products Inc. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Microbiota
- What is being tested?
- Resistant Potato Starch
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteCanada
- Study dates
- 29 May 2025to 3 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.).
- Reports a clinically significant illness during the 28 days before the first dose of study product.
- Major surgery in 3 months prior to screening or planned major surgery during the study.
- 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.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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
- Being tested
- Resistant Potato Starch, Placebo
- Keywords
- Gastrointestinal, Microbiota, Gut, healthy adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistant Potato StarchDietary supplement
Active Ingredients: 3.5 g potato starch Inactive ingredients: 3.5 g corn starch
PlaceboOther
Active Ingredients: N/A Inactive Ingredients: 7 g corn starch
| Study group | Role | What they receive |
|---|---|---|
| Resistant Potato Starch | Experimental | Active: 1 sachet per day oral Receives: Dietary Supplement: Resistant Potato Starch |
| Placebo | Placebo comparator | Placebo: 1 Sachet per day oral Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Change from baseline to Week 4 in the relative abundance of Bifidobacterium genus, as assessed via 16S rRNA sequencing of fecal samples
Measured: Week 4
To assess the effect of RPS on stool form (consistency) after 3 weeks of supplementation, compared to a placebo
Change from baseline to Week 4 in consistency score and the incidence of the following stool types, as assessed by Bristol Stool Form Scale (BSFS) in daily diaries: Constipated stools (type 1 or 2)
Measured: Week 4
To assess the effect of RPS on stool form (consistency) after 3 weeks of supplementation, compared to a placebo
Change from baseline to Week 4 in consistency score and the incidence of the following stool types, as assessed by Bristol Stool Form Scale (BSFS) in daily diaries:Diarrheal stools (type 6 or 7)
Measured: 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
Change from baseline to Week 4 in the average number of daily BMs, as assessed by daily diaries
Measured: Week 4
To assess the effect of RPS on gastrointestinal (GI) symptoms after 4 weeks of supplementation, compared to a placebo
Change from baseline to Week 4 in GI symptoms, as assessed by Gastrointestinal Symptoms Rating Scale (GSRS)
Measured: Week 4
To assess the effect of RPS on general well-being after 4 weeks of supplementation, compared to a placebo
Change from baseline to Week 4 in general well-being, as assessed by The World Health Organization Quality of Life - BREF (WHOQOL-BREF)
Measured: Week 4
To assess the effect of RPS on health-related quality of life (QOL) after 4 weeks of supplementation, compared to a placebo
Change from baseline to Week 4 in health-related QOL, as assessed by RAND 36-Item Health Survey 1.0 (RAND-36)
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start29 May 2025
- Primary completion3 Oct 2025
- Study completion3 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal MicrobiotaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- MSP Starch Products Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Responsible party
- Sponsor
- Investigators
- Jason Bush, Chief Scientific Officer, Study director, MSP Starch Products Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06949631
- Sponsor's protocol ID
- M03-25-01-T0081
- Status last verified
- Nov 2025
- First submitted
- 22 Apr 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06949631
- Acronym / sponsor ID
- M03-25-01-T0081
- Conditions
- Gastrointestinal Microbiota
- Keywords
- Gastrointestinal, Microbiota, Gut, healthy adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- MSP Starch Products Inc.Industry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Study start
- 29 May 2025 (actual)
- Primary completion
- 3 Oct 2025 (actual)
- Study completion
- 3 Oct 2025 (actual)
- First posted
- 29 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistant Potato Starch | Experimental | Dietary Supplement: Resistant Potato StarchActive: 1 sachet per day oral |
| Placebo | Placebo comparator | Other: PlaceboPlacebo: 1 Sachet per day oral |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistant Potato StarchActive Ingredients: 3.5 g potato starch Inactive ingredients: 3.5 g corn starch | Dietary supplement | Resistant Potato Starch |
| PlaceboActive Ingredients: N/A Inactive Ingredients: 7 g corn starch | Other | Placebo |
Primary outcome
To assess the shifts in Akkermansia genus in gut microbiota after 4 weeks of resistant potato starch (RPS) supplementation, compared to a placebo
Time frame: Week 4
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
7 secondary outcomes
To assess the shifts in Bifidobacterium genus in gut microbiota after 4 weeks of RPS supplementation, compared to a placebo
Time frame: Week 4
To assess the effect of RPS on stool form (consistency) after 3 weeks of supplementation, compared to a placebo
Time frame: Week 4
To assess the effect of RPS on stool form (consistency) after 3 weeks of supplementation, compared to a placebo
Time frame: 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
Time frame: Week 4
To assess the effect of RPS on gastrointestinal (GI) symptoms after 4 weeks of supplementation, compared to a placebo
Time frame: Week 4
To assess the effect of RPS on general well-being after 4 weeks of supplementation, compared to a placebo
Time frame: Week 4
To assess the effect of RPS on health-related quality of life (QOL) after 4 weeks of supplementation, compared to a placebo
Time frame: Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Bush, Chief Scientific Officer study director
MSP Starch Products Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistant Potato Starch in people with Gastrointestinal Microbiota, run by MSP Starch Products Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the shifts in Akkermansia genus in gut microbiota after 4 weeks of resistant potato starch (RPS) supplementation, compared to a placebo (time frame: Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.