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

Not Applicable
Completed
Conditions
Healthy Volunteers
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

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
Primary Outcome Measures
NameTimeMethod
Gut microbiome7 weeks

16S rRNA gene survey of gut microbial communities

Fecal short-chain fatty acid concentration7 weeks

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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Cornell University

🇺🇸

Ithaca, New York, United States

Cornell University
🇺🇸Ithaca, New York, United States

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