Effects of Resistant Potato Starch on the Gut Microbiota

Study Overview
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Brief Summary
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This was a randomized, double-blind, three-arm, parallel group clinical trial, which assessed the shifts that occur in microbial populations after four weeks of supplementation with resistant potato starch (SolnulTM) at two different dosages, in comparison to a placebo in healthy adults.

Official Title
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A Randomized Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Effects of Resistant Potato Starch (SolnulTM) on Intestinal Flora

Conditions
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Microbiota

Intervention / Treatment
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* Dietary Supplement: Resistant Potato Starch
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI between 18.0 and 34.9 kg/square meter (inclusive) that were generally healthy as determined by medical history and screening blood work. Exclusion Criteria: Diagnosis of Irritable Bowel Syndrome (IBS), dyspepsia, significant gastrointestinal disorders, or other major diseases.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High Dose SolnulTM<br>7.0 g of Resistant Potato Starch administered daily for 4 weeks | Dietary Supplement: Resistant Potato Starch<br>* Unmodified potato starch containing >60% resistant starch Type 2<br>* Other names: MSPrebiotic;|
| Active Comparator: Low Dose SolnulTM<br>3.5 g of Resistant Potato Starch (plus 3.5 g digestible corn starch for 7.0 g total carbohydrate) administered daily for 4 weeks | Dietary Supplement: Resistant Potato Starch<br>* Unmodified potato starch containing >60% resistant starch Type 2<br>* Other names: MSPrebiotic;|
| Placebo Comparator: Placebo<br>7.0 g digestible corn starch administered daily for 4 weeks | Dietary Supplement: Placebo<br>* Fully digestible corn starch<br>* Other names: AmiocaTM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in relative abundance (% of gut microbiome) of Bifidobacterium from stool between treatment groups | Changes in relative abundance of Bifidobacterium after 4 weeks of consumption in High Dose, Low Dose, and placebo arms are compared. | Four weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in relative abundance (% of gut microbiome) of Bifidobacterium from stool between treatment groups | Changes in relative abundance of Bifidobacterium after 1 week of consumption in High Dose, Low Dose, and placebo arms are compared. | One week | 
| Changes in relative abundance (% of gut microbiome) of Bifidobacterium from stool within treatment groups | Changes in relative abundance of Bifidobacterium between baseline and one or four week timepoints for High Dose, Low Dose, and Placebo arms. | One week, four weeks | 
| Fecal SCFA (mmol/kg stool) changes from baseline | Between and within group comparisons of SCFA levels in stool for High Dose, Low Dose, and Placebo arms | One week, four weeks | 
| Changes from baseline in stool consistency using self-reported Bristol Stool Chart scores | Changes in constipation and diarrhea frequency in High Dose, Low Dose, and Placebo arms. | One week, four weeks | 
| Changes from baseline in gastrointestinal symptoms using the a modified Gastrointestinal Quality of Life Index scale | Changes in bloating, belching, abdominal pain, gas, and overall well-being in High Dose, Low Dose, and Placebo arms. | One week, four weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microbiota, Resistant Potato Starch, Bristol Stool Chart, Diarrhea, Constipation, Bloating, Abdominal Pain, Gas, Well-being