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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Dose SolnulTM | Active Comparator | 7.0 g of Resistant Potato Starch administered daily for 4 weeks |
|
| Low Dose SolnulTM | Active Comparator | 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 |
|
| Placebo | Placebo Comparator | 7.0 g digestible corn starch administered daily for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resistant Potato Starch | Dietary Supplement | Unmodified potato starch containing >60% resistant starch Type 2 |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Beir, MD | Nutrasource Pharmaceutical and Nutraceutical Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nutrasource Pharmaceutical and Nutraceutical Services | Guelph | Ontario | N1G 0B4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39605008 | Derived | Bush JR, Alfa MJ. Consumption of resistant potato starch produces changes in gut microbiota that correlate with improvements in abnormal bowel symptoms: a secondary analysis of a clinical trial. BMC Nutr. 2024 Nov 27;10(1):152. doi: 10.1186/s40795-024-00962-7. |
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| ID | Term |
|---|---|
| D003967 | Diarrhea |
| D003248 | Constipation |
| D015746 | Abdominal Pain |
| D009085 | Mucopolysaccharidosis IV |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| Placebo | Dietary Supplement | Fully digestible corn starch |
|
|
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 |
| D009461 | Neurologic Manifestations |
| D009083 | Mucopolysaccharidoses |
| D002239 | Carbohydrate Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D016464 | Lysosomal Storage Diseases |
| D017520 | Mucinoses |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |