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Dietary Fiber Effects on the Microbiome and Satiety

RecruitingNAAges 20 Years - 55 YearsAllUniversity of Missouri-Columbia
NCT04611217 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Strong evidence supports the association between high fiber (HiFi) diets (e.g. legumes, nuts, vegetables) and a reduced risk for chronic conditions such as cardiovascular disease (CVD), type 2 diabetes and some forms of cancer. However, the current U.S. average consumption of dietary fiber of 17g/day is significantly below the recommendation level of 25g/d for women and 38g/d for men. Furthermore, fiber fermentation to produce short chain fatty acid (SCFA) products and alterations in microbial composition and activity may be mechanisms linking a HiFi diet to improved health. Importantly, much of the data, including findings supporting a beneficial role of SCFA have been derived from animal studies. Human studies are now needed to advance the understanding of the translational significance of rodent studies and the potential benefit of fiber on microbial metabolites and cardiometabolic he

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📋 Eligibility rules (as published)
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)
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What it tests

  • Dietary fiber: 10-25g
  • Dietary fiber: 5g
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Where

1 site
University of Missouri-Columbia
Columbia, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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