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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05743790
• Other study ID #: 1902008575
• Status: Completed
• Phase: N/A
• Start date: September 26, 2019
• Est. completion date: December 15, 2020

Study information

• Verified date: March 2023
• Source: Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: December 15, 2020
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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

Locations

Country	Name	City	State
United States	Cornell University	Ithaca	New York

Sponsors (1)

Lead Sponsor	Collaborator
Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gut microbiome	16S rRNA gene survey of gut microbial communities	7 weeks
Primary	Fecal short-chain fatty acid concentration	Fecal short-chain fatty acid concentration measurements with ultra-performance liquid chromatography	7 weeks