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

NCT ID: NCT05743790

Last Updated: 2023-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 196 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-26
• Study Completion Date: 2020-12-15

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

RS2-control-RS4

Intervention Type: DIETARY_SUPPLEMENT

Group A: Treatment 1 = RS2 (Hi-Maize 260), Treatment 2 = Control (Amioca TF), Treatment 3 = RS4 (Versafibe 1490)

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.

Group Type: EXPERIMENTAL

RS4-control-RS2

Intervention Type: DIETARY_SUPPLEMENT

Group B: Treatment 1 = RS4 (Versafibe 1490), Treatment 2 = Control (Amioca TF), Treatment 3 = RS2 (Hi-Maize 260)

Interventions

RS2-control-RS4

Group A: Treatment 1 = RS2 (Hi-Maize 260), Treatment 2 = Control (Amioca TF), Treatment 3 = RS4 (Versafibe 1490)

Intervention Type: DIETARY_SUPPLEMENT

RS4-control-RS2

Group B: Treatment 1 = RS4 (Versafibe 1490), Treatment 2 = Control (Amioca TF), Treatment 3 = RS2 (Hi-Maize 260)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cornell University

Ithaca, New York, United States

Countries

United States

Other Identifiers

1902008575

Identifier Type: -

Identifier Source: org_study_id