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

NCT05743790 | Completed

• 1 other identifier: 1902008575
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Gut microbiome

  16S rRNA gene survey of gut microbial communities

  7 weeks

• Fecal short-chain fatty acid concentration

  Fecal short-chain fatty acid concentration measurements with ultra-performance liquid chromatography

  7 weeks

Study Arms (2)

Group A: RS2 first

EXPERIMENTAL

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.

Dietary Supplement: RS2-control-RS4

Group B: RS4 first

EXPERIMENTAL

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.

Dietary Supplement: RS4-control-RS2

Interventions

RS2-control-RS4 DIETARY_SUPPLEMENT

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

Group A: RS2 first

RS4-control-RS2 DIETARY_SUPPLEMENT

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

Group B: RS4 first

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Above 18 years of age
• Willing to consume the supplements provided throughout the duration of the study

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cornell University: lead

Study Sites (1)

Cornell University

Ithaca, New York, 14853, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: February 24, 2023
• Study Start: September 26, 2019
• Primary Completion: December 15, 2020
• Study Completion: December 15, 2020
• Last Updated: April 3, 2023

Record last verified: 2023-03

Locations

US (1)