Healthy Volunteers
Conditions
Brief summary
Resistant starch (RS), a type of dietary fiber, was shown to have beneficial effects on human health through its impact on microbes present in the intestine. However, the effects of RS on the gut microbiota and in turn, on human health, can vary between individuals. Consequently, everyone may not reap the same health benefits by eating high amounts of RS. Factors predicting how an individual's gut microbes as well as the beneficial metabolites produced by these microbes respond to RS supplementation would be helpful in developing precision nutrition approaches that maximize the benefits of dietary fiber intake. The objective of this study was to evaluate candidate predictors of gut microbiota response to RS supplementation.
Interventions
DIETARY_SUPPLEMENTRS2-control-RS4
Group A: Treatment 1 = RS2 (Hi-Maize 260), Treatment 2 = Control (Amioca TF), Treatment 3 = RS4 (Versafibe 1490)
DIETARY_SUPPLEMENTRS4-control-RS2
Group B: Treatment 1 = RS4 (Versafibe 1490), Treatment 2 = Control (Amioca TF), Treatment 3 = RS2 (Hi-Maize 260)
Sponsors
Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
We originally enrolled 196 participants and collected saliva samples for screening to participate in the intervention. Then we enrolled 76 participants in the intervention study. These participants were randomly assigned to one of two parallel arms in the intervention study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Above 18 years of age * Willing to consume the supplements provided throughout the duration of the study
Exclusion criteria
* History of diabetes, prediabetes or impaired glucose tolerance. * Existing, UNTREATED, thyroid condition. * Usage of systemic antibiotics (intravenous injection, intramuscular, or oral) within 6 months prior to the study. * Acute disease at the time of enrollment. * Chronic, clinically significant pulmonary, cardiovascular, gastrointestinal, hepatic, or renal functional abnormality. * History of active UNTREATED gastrointestinal disorders or diseases including: i. Inflammatory bowel disease (IBD) ii. Ulcerative colitis (mild-moderate-severe) iii. Crohn's disease (mild- moderate-severe) iv. Indeterminate colitis v. Irritable bowel syndrome (IBS) (moderate-severe) vi. Persistent, infectious gastroenteritis, colitis or gastritis vii. Persistent or chronic diarrhea of unknown etiology viii. Clostridium difficile infection (recurrent) ix. Chronic constipation * Suspected state of immunosuppression or immunodeficiency including HIV. * History of bariatric surgery. * Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gut microbiome | 7 weeks | 16S rRNA gene survey of gut microbial communities |
| Fecal short-chain fatty acid concentration | 7 weeks | Fecal short-chain fatty acid concentration measurements with ultra-performance liquid chromatography |
Countries
United States
Outcome results
None listed