Resistant Potato Starch for Gut Bacteria

Overseen By Stephanie Recker

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: MSP Starch Products Inc.

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

74 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Resistant Potato Starch for gut bacteria?

Research shows that resistant potato starch can change the gut microbiome by increasing beneficial bacteria and short-chain fatty acids, which are important for gut health. It also suggests that resistant starch may help improve gastrointestinal symptoms and reduce diarrhea. ^{1 2 3 4 5}

Is resistant potato starch safe for human consumption?

Research on resistant potato starch, primarily conducted in animal studies, suggests it is generally safe. A clinical trial with a resistant starch blend, including potato starch, showed no harmful effects and even improved gastrointestinal symptoms and sleep quality in humans. ^{1 4 5 6 7}

How does resistant potato starch treatment differ from other treatments for gut bacteria?

Resistant potato starch is unique because it acts as a prebiotic, meaning it feeds beneficial gut bacteria, leading to increased production of short-chain fatty acids that support gut health. Unlike other treatments, it specifically alters the gut microbiome composition and enhances the growth of beneficial bacteria like lactic acid bacteria. ^{1 2 5 6 8}

What is the purpose of this trial?

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.

Research Team

Jason Bush, Chief Scientific Officer

Principal Investigator

MSP Starch Products Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. China pubmed.ncbi.nlm.nih.gov

[Influence of resistant starch on colon flora of rats]. [2005]

2. Switzerland 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. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of lotus seed resistant starch on tolerance of mice fecal microbiota to bile salt. [2021]

4. Switzerland 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. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Potato powders prepared by successive cooking-process depending on resistant starch content affect the intestinal fermentation in rats. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Feeding resistant starch affects fecal and cecal microflora and short-chain fatty acids in rats. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

Novel Resistant Starch Type 4 Products of Different Starch Origins, Production Methods, and Amounts Are Not Equally Fermented when Fed to Sprague-Dawley Rats. [2023]

8. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Influence modified and resistant potato starches on the E. coli culture]. [2020]