Effects of Resistant Potato Starch on the Gut Microbiota
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: High Dose SolnulTM 7.0 g of Resistant Potato Starch administered daily for 4 weeks |
Dietary Supplement: Resistant Potato Starch
Unmodified potato starch containing >60% resistant starch Type 2
Other Names:
|
| Active Comparator: Low Dose SolnulTM 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
Unmodified potato starch containing >60% resistant starch Type 2
Other Names:
|
| Placebo Comparator: Placebo 7.0 g digestible corn starch administered daily for 4 weeks |
Dietary Supplement: Placebo
Fully digestible corn starch
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nutrasource Pharmaceutical and Nutraceutical Services | Guelph | Ontario | Canada | N1G 0B4 |
Sponsors and Collaborators
- Manitoba Starch Products
Investigators
- Principal Investigator: Anthony Beir, MD, Nutrasource Pharmaceutical and Nutraceutical Services
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- R10356