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Dietary Fiber Effects on the Microbiome and Satiety

University of Missouri-Columbia · NCT04611217

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 20–55 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
88
US sites recruiting
1
Study start
April 22, 2021
Record last updated
June 22, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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 health, glucose regulation, appetite and satiety. The central hypothesis is that that the mechanisms by which dietary fiber provides metabolic benefit include direct physical effects in the upper gastrointestinal tract to slow nutrient absorption, and indirect effects to reduce food intake mediated by SCFA-induced secretion of intestinal hormones resulting in increased satiety. Design: Using fiber derived from peas, Aim 1 will test the effect of a HiFi diet on appetite, satiety, and cardiometabolic health and whether elevated SCFA concentration mediates improved satiety in 44 overweight/obese subjects randomly assigned to receive either a high fiber or a low fiber dietary intervention for four weeks in a parallel arm-repeated measures design. Aim 2 will quantitate the changes in microbial composition and colonic SCFA production rate during HiFi feeding and whether any changes are potential mediators of observed benefits on satiety and cardiometabolic risk factors in 26 subjects assigned to receive a high fiber intervention for 3 weeks in a repeated measures design. Relevance: These studies will significantly expand the understanding of mechanisms by which dietary fiber improves satiety and cardiometabolic health in humans.

Being studied: Dietary fiber: 10-25g; Dietary fiber: 5g

Conditions: Dietary Fiber

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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)
  • 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)

Recruiting US locations

  • University of Missouri-Columbia

    Columbia, MO 65212

    Site contact: Katherene O Anguah, Ph.D · 573-882-8966 · anguahk@missouri.edu

Study contacts (from the official record)

  • Katherene OB Anguah, PhD · (573)-882-8966 · anguahk@missouri.edu
Dietary Fiber Effects on the Microbiome and Satiety (NCT04611217) | Bored Studies