Resistant Potato Starch for Gut Bacteria

Overseen By Stephanie Recker

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: MSP Starch Products Inc.

Disqualifiers: Pregnancy, GI disorders, Diabetes, Cancer, others

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how Resistant Potato Starch affects gut bacteria in healthy adults. Participants will take a daily sachet of either the starch or a placebo for four weeks, while maintaining a diary of their digestive habits and quality of life. It suits adults with stable dietary habits and no serious digestive issues. The goal is to determine if this starch can positively change gut bacteria compared to not taking it. As a Phase 4 trial, this research aims to understand how this FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

The trial requires participants to maintain consistent medication and supplement intake throughout the study, so you should not stop taking your current medications if they have been stable for at least 90 days.

What is the safety track record for Resistant Potato Starch?

Research shows that resistant potato starch is generally safe and easy for most people to handle. Studies indicate that it can improve gut health by producing important fatty acids during digestion. These studies have reported no serious side effects.

Resistant starch occurs in common foods like potatoes and grains, which many people consume without issues, suggesting its safety for most individuals.

The trial's later phase indicates strong evidence of its safety in humans. Participants can feel confident that the risks are low while exploring its potential benefits for gut health. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Resistant Potato Starch is unique because it aims to improve gut health by serving as a prebiotic, which helps beneficial bacteria thrive in the digestive system. Unlike other treatments that may rely on probiotics or dietary changes to boost gut bacteria, this starch works by providing a specific type of fiber that resists digestion in the small intestine, reaching the colon intact. Researchers are excited about its potential to naturally enhance the gut microbiome, offering a simple, daily oral supplement as a novel approach to supporting digestive health.

What evidence suggests that Resistant Potato Starch might be an effective treatment for gut bacteria?

Research shows that resistant potato starch, which participants in this trial may receive, benefits gut health. Studies have found that it can alter the microorganisms in the digestive system, improving bowel symptoms. Consuming resistant potato starch produces important substances that enhance gut function. Some research also suggests it can change the balance and variety of gut bacteria, although results may vary among individuals. Overall, resistant potato starch is recognized for its potential benefits to gut health. ^{5 6 7 8 9}

Who Is on the Research Team?

Jason Bush, Chief Scientific Officer

Principal Investigator

MSP Starch Products Inc.

Are You a Good Fit for This Trial?

This trial is for healthy adults interested in how a dietary supplement, Resistant Potato Starch, might change their gut bacteria. Participants should be willing to provide stool samples and keep a daily diary of their digestive health.

Inclusion Criteria

Agree to use acceptable contraceptive methods

Have a BMI between 18.0 to 34.9 kg/m2 (inclusive)

In good general health as deemed by the investigator, medical history, and screening bloodwork

Exclusion Criteria

Individuals who are lactating, pregnant, or planning to become pregnant during the study

Have a known sensitivity, intolerability, or allergy to any study products or their excipients

Abnormal safety laboratory values as per the Investigator's discretion

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Run-in

Participants complete a daily diary to track stool form and frequency, general health changes, and any other medications they are taking

1 week

Treatment

Participants receive either Resistant Potato Starch or placebo for 4 weeks, providing stool samples and recording daily information in a diary

4 weeks

Weekly visits for sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Resistant Potato Starch

Trial Overview The study tests the effects of Resistant Potato Starch on gut microbiota over four weeks against a placebo. Participants will take either the starch or placebo and track changes through stool samples and daily records.

How Is the Trial Designed?

Group I: Resistant Potato Starch Experimental Treatment 1 Intervention

Active: 1 sachet per day oral

Group II: Placebo Placebo Group 1 Intervention

Placebo: 1 Sachet per day oral

Who Is Running the Clinical Trial?

MSP Starch Products Inc.

Lead Sponsor

Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

Collaborator

Trials

40

Recruited

2,400+

Published Research Related to This Trial

Resistant starch (both RS2 and RS3) significantly improved the colon flora in mice by increasing beneficial bifidobacteria and decreasing harmful enterobacteria, indicating a positive effect on gut health.

The intake of RS2, particularly at higher concentrations, led to increased production of short-chain fatty acids (SCFAs) and a reduction in the pH of feces and cecum content, suggesting enhanced fermentation and overall digestive health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Influence of resistant starch on colon flora of rats]. He, M., Hong, J., Yang, YX., et al.[2005]

Mice fed a diet high in resistant potato starch (RPS) showed increased susceptibility to bacterial-induced colitis, with higher levels of infection and colonization by the pathogen Citrobacter rodentium compared to those not fed RPS.

The study revealed that high RPS consumption altered the microbiome composition and gene expression in the colon, potentially leading to immunosuppressive effects that could increase vulnerability to gastrointestinal infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Raw potato starch alters the microbiome, colon and cecal gene expression, and resistance to Citrobacter rodentium infection in mice fed a Western diet. Smith, AD., Chen, C., Cheung, L., et al.[2023]

Rats fed raw potato powder (RP) showed significantly higher levels of resistant starch and beneficial lactic acid bacteria compared to those on a control diet, indicating that RP may enhance gut health.

The RP group also had lower cecal pH and higher concentrations of short-chain fatty acids (SCFAs), suggesting that raw potato powder can positively influence intestinal fermentation and microbial activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potato powders prepared by successive cooking-process depending on resistant starch content affect the intestinal fermentation in rats. Kawakami, S., Han, KH., Araki, T., et al.[2018]

A clinical trial with varying doses of a novel resistant starch blend (RSB) showed that consuming around 5 g of resistant starch daily can improve gastrointestinal symptoms over a period of 6 weeks, particularly reducing diarrhea scores.

Higher doses of the RSB blend were linked to reduced sleep disturbances and changes in gut microbiome composition, specifically increasing beneficial bacteria like Faecalibacterium and Akkermansia, which are associated with better human health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The gastrointestinal and microbiome impact of a resistant starch blend from potato, banana, and apple fibers: A randomized clinical trial using smart caps. Hanes, D., Nowinski, B., Lamb, JJ., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9559413/

A randomized clinical trial using smart caps Results confirmed that while resistant starch of approximately 5 g per day improves GI symptoms at 2, 4, and 6 weeks, it did not demonstrate a ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2590157524000051

Resistant starch and the gut microbiome Resistant starch (RS) modulates gut microbiome for health benefits. RS fermentation produces vital volatile fatty acids for gut health.

3. bmcnutr.biomedcentral.com bmcnutr.biomedcentral.com/articles/10.1186/s40795-024-00962-7

Consumption of resistant potato starch produces changes in ... Consumption of resistant potato starch produces changes in gut microbiota that correlate with improvements in abnormal bowel symptoms: a ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8288039/

Resistant starch, microbiome, and precision modulation Attempts to leverage resistant starch as microbiome-modifying interventions in clinical studies have yielded remarkable inter-individual variation.

5. mdpi.com mdpi.com/2072-6643/14/3/721

Additional Resistant Starch from One Potato Side Dish per ... Intake of one potato-based side dish per day resulted in modest changes in gut microbiota composition and diversity, compared to isocaloric intake of refined ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10819196/

Resistant starch and the gut microbiome - PubMed Central - NIH Resistant starch (RS) modulates gut microbiome for health benefits. RS fermentation produces vital volatile fatty acids for gut health.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06949631

Study on the Effects of Resistant Potato Starch on Gut ... 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.

8. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2022.987216/full

The gastrointestinal and microbiome impact of a resistant ... High levels of resistant starch have been associated with health benefits and altering gut microbiota levels. The most recognized RS research supports the ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S1756464622001645

Health benefits of resistant starch: A review of the literature Diets high in resistant starch increase plasma levels of trimethylamine-N-oxide, a gut microbiome metabolite associated with CVD risk. British Journal of ...