The Role of Dietary Intake and Host Genetics in Gut Microbiome Response to Resistant Starch Consumption
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cornell University
- Enrollment
- 196
- Locations
- 1
- Primary Endpoint
- Gut microbiome
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Group A: RS2 first
Crackers were provided during each of 3 treatment periods in a crossover design. The 3 types of crackers were matched for total carbohydrate content. Treatment period 1 (10 days): After a 3-day ramp up, participants received 120g of crackers/day containing resistant starch type 2 (30g/day) for 7 days; Treatment period 2 (10 days): Participants received control crackers with 100% digestible starch; Treatment period 3 (10 days): After a 3-day ramp up, participants received 120g of crackers/day containing resistant starch type 4 (30g/day) for 7 days. There were 5-day washout periods between the treatment periods.
Intervention: RS2-control-RS4 (Dietary Supplement)
Group B: RS4 first
Crackers were provided during each of 3 treatment periods in a crossover design. The 3 types of crackers were matched for total carbohydrate content. Treatment period 1 (10 days): After a 3-day ramp up, participants received 120g of crackers/day containing resistant starch type 4 (30g/day) for 7 days; Treatment period 2 (10 days): Participants received control crackers with 100% digestible starch; Treatment period 3 (10 days): After a 3-day ramp up, participants received 120g of crackers/day containing resistant starch type 2 (30g/day) for 7 days. There were 5-day washout periods between the treatment periods.
Intervention: RS4-control-RS2 (Dietary Supplement)
Outcomes
Primary Outcomes
Gut microbiome
Time Frame: 7 weeks
16S rRNA gene survey of gut microbial communities
Fecal short-chain fatty acid concentration
Time Frame: 7 weeks
Fecal short-chain fatty acid concentration measurements with ultra-performance liquid chromatography
Secondary Outcomes
No secondary outcomes reported