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| Name | Class |
|---|---|
| Nutrasource Pharmaceutical and Nutraceutical Services, Inc. | NETWORK |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resistant Potato Starch | Experimental | Active: 1 sachet per day oral |
|
| Placebo | Placebo Comparator | Placebo: 1 Sachet per day oral |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resistant Potato Starch | Dietary Supplement | Active Ingredients: 3.5 g potato starch Inactive ingredients: 3.5 g corn starch |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Week 4 |
| To assess the effect of RPS on stool form (consistency) after 3 weeks of supplementation, compared to a placebo |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the effect of RPS on leaky gut after 4 weeks of supplementation, compared to a placebo | Change from baseline to Week 4 in serum zonulin and lipopolysaccharide (LPS) | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Bush, Chief Scientific Officer | MSP Starch Products Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Apex Trials | Guelph | Ontario/ON | N1G 0B4 | Canada |
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| Placebo | Other | Active Ingredients: N/A Inactive Ingredients: 7 g corn starch |
|
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) |
| 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) | 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 | 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) | 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) | 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) | Week 4 |
Change from baseline to Week 4 in abundance of gut microbiota and relevant metagenomic material, identified in metagenomic analyses of stool samples |
| 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 | Change from baseline to Week 4 in abundance of gut microbiota and relevant metagenomic material, identified in metagenomic analyses of stool samples | Week 4 |
| To assess the safety of RPS | Reports of adverse events (AEs) | From Week 1 to Week 4 |