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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05242913
Other study ID # R10356
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 30, 2019
Est. completion date January 6, 2020

Study information

Verified date February 2022
Source Manitoba Starch Products
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date January 6, 2020
Est. primary completion date January 6, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 69 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Resistant Potato Starch
Unmodified potato starch containing >60% resistant starch Type 2
Placebo
Fully digestible corn starch

Locations

Country Name City State
Canada Nutrasource Pharmaceutical and Nutraceutical Services Guelph Ontario

Sponsors (1)

Lead Sponsor Collaborator
Manitoba Starch Products

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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