Clinical trial Recruiting at 1 site Interventional Ages 20 to 55

Effects of dietary fiber on gut health and appetite

Official title: Mechanisms Linking Dietary Fiber, the Microbiome and Satiety

Run by University of Missouri-Columbia · NCT04611217 · Data updated 2026-11-12

This study is testing how eating more fiber affects gut health and feelings of fullness in premenopausal men and women aged 20 to 55.

More Dietary Fiber trials

Quick facts

Study typeInterventional
Ages20 Years to 55 Years
SexAll
Enrollment88 (estimated)
SponsorUniversity of Missouri-Columbia
Academic / other
Locations1 site (Columbia, Missouri)
StatusRecruiting
StartedApril 22, 2021
Main results expectedAugust 1, 2025
Study endsAugust 1, 2025
Registry record updatedJune 22, 2025
Trial IDNCT04611217 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are premenopausal men and women aged 20-55 with a BMI between 25 and 35, who exhibit at least one characteristic of metabolic syndrome.

Probably not a fit

Patients who are pregnant, lactating, or postmenopausal will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates how high fiber diets impact the microbiome and satiety in premenopausal men and women aged 20-55. Participants will consume varying amounts of dietary fiber while providing blood and fecal samples to assess changes in microbial composition and short chain fatty acid production. The research aims to clarify the relationship between fiber intake, gut health, and metabolic syndrome characteristics, particularly focusing on appetite regulation and glucose metabolism. The findings could help translate animal study results into human health benefits.

Why it matters

Potential benefit: If successful, this study could lead to improved dietary recommendations that enhance gut health and metabolic outcomes for individuals at risk of chronic diseases.

How similar studies have gone: While many animal studies have shown promising results regarding dietary fiber and gut health, human studies exploring these effects are still emerging.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Men and women (premenopausal only)
* Age 20-55y (Aim 1); 45-55y (Aim 2)
* BMI ≥25 or ≤35 kg/m2 (Aim 1); ≥25 or ≤40 (Aim 2)
* Weight stable (no fluctuations in body weight of greater than 4 kg in the last 3 months)
* Willing to consume a research diet
* Willing to provide blood and fecal samples
* At least one characteristic of the metabolic syndrome (but not diabetic)

  1\. A large waistline: 35 inches or more for women 40 inches or more for men 2. High triglycerides: 150 mg/dL or higher 3. Low HDLc level: \<50 mg/dL for women \<40 mg/dL for men 4. High blood pressure ≥130/85 mmHg 5. Fasting blood sugar ≥100 mg/dL
* Pre-diabetes acceptable (glucose \<125 mg/dL or HbA1c \<6.5%)
* Stably treated with statin drugs, anti-hypertensives, and anti-depressants. These are acceptable as long as the drug category does not alter appetite, body weight, or the microbiome (if known)

Exclusion Criteria:

* Pregnant or lactating
* Postmenopausal (evidence suggests an interplay between the gut microbiome)
* BMI of \<25 or \>35 kg/m2 (Aim 1); \<25 or \>40 kg/m2 (Aim 2)
* Use of medications that affect the gut microbiome (e.g. antibiotics)
* Taking medications known to affect appetite (e.g., phentermine) or gastrointestinal function (e.g., metformin)
* On a special diet or undergoing weight loss, vegetarian, or other restricted dietary patterns
* Ad libitum intake of fiber above 25g/day (mean intake in the US population is 17g/day) and \< 10g/d
* Ad libitum alcohol intake of greater than 1 drink/d for women and 2 drinks/d for men
* History of disease (example colon cancer, HIV, cardiovascular disease, psychiatric disorders, etc.)
* Use of tobacco products
* Having metal or implants in the body that are not MRI compatible (Aim 1 only)

Where it's running

  • University of Missouri-Columbia
    Columbia, Missouri, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  • Dietary fiber effects on breath VOCs in healthy adults

    This study tests how a short course of high- versus low-fiber diets changes the volatile compounds in breath for healthy adults aged 18–65.

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.