The Role of Dietary Intake and Host Genetics in Gut Microbiome Response to Resistant Starch Consumption

Not Applicable

Completed

• Conditions: Healthy Volunteers
• Interventions: Dietary Supplement: RS4-control-RS2; Dietary Supplement: RS2-control-RS4

• Registration Number: NCT05743790
• Lead Sponsor: Cornell University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-26
• Primary Completion: 2020-12-15
• Study Completion: 2020-12-15
• Study First Submitted: 2023-02-15
• Study First Submitted QC: 2023-02-15
• Study First Posted: 2023-02-24
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-30
• Last Update Posted: 2023-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 196

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group B: RS4 first	RS4-control-RS2	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.
Group A: RS2 first	RS2-control-RS4	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.

Primary Outcome Measures

Name	Time	Method
Fecal short-chain fatty acid concentration	7 weeks	Fecal short-chain fatty acid concentration measurements with ultra-performance liquid chromatography
Gut microbiome	7 weeks	16S rRNA gene survey of gut microbial communities

Trial Locations

Locations (1)

Cornell University; 🇺🇸 Ithaca, New York, United States