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OpenTrials
Completed

NCT Number: NCT05743790

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cornell University

Ithaca, New York, 14853, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RS2-control-RS4

Dietary Supplement

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

RS4-control-RS2

Dietary Supplement

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

Primary outcomes

  1. Gut microbiome

    Time frame: 7 weeks

    16S rRNA gene survey of gut microbial communities

  2. Fecal short-chain fatty acid concentration

    Time frame: 7 weeks

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

Sponsors and collaborators

Lead sponsor

Cornell University

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 24, 2023
Registry last updated
Apr 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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