Microbiota
Conditions
Keywords
Microbiota, Resistant Potato Starch, Bristol Stool Chart, Diarrhea, Constipation, Bloating, Abdominal Pain, Gas, Well-being
Brief 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.
Interventions
DIETARY_SUPPLEMENTResistant Potato Starch
Unmodified potato starch containing \>60% resistant starch Type 2
DIETARY_SUPPLEMENTPlacebo
Fully digestible corn starch
Sponsors
MSP Starch Products Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in relative abundance (% of gut microbiome) of Bifidobacterium from stool between treatment groups | Four weeks | Changes in relative abundance of Bifidobacterium after 4 weeks of consumption in High Dose, Low Dose, and placebo arms are compared. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in relative abundance (% of gut microbiome) of Bifidobacterium from stool between treatment groups | One week | Changes in relative abundance of Bifidobacterium after 1 week of consumption in High Dose, Low Dose, and placebo arms are compared. |
| Changes in relative abundance (% of gut microbiome) of Bifidobacterium from stool within treatment groups | One week, four weeks | Changes in relative abundance of Bifidobacterium between baseline and one or four week timepoints for High Dose, Low Dose, and Placebo arms. |
| Fecal SCFA (mmol/kg stool) changes from baseline | One week, four weeks | Between and within group comparisons of SCFA levels in stool for High Dose, Low Dose, and Placebo arms |
| Changes from baseline in stool consistency using self-reported Bristol Stool Chart scores | One week, four weeks | Changes in constipation and diarrhea frequency in High Dose, Low Dose, and Placebo arms. |
| Changes from baseline in gastrointestinal symptoms using the a modified Gastrointestinal Quality of Life Index scale | One week, four weeks | Changes in bloating, belching, abdominal pain, gas, and overall well-being in High Dose, Low Dose, and Placebo arms. |
Countries
Canada
Outcome results
None listed