Recruiting

Dietary Fiber

Sponsor:

University of Missouri-Columbia

Code:

NCT04611217

Conditions

Dietary Fiber

Eligibility Criteria

Sex: All

Age: 20 - 55

Healthy Volunteers: Accepted

Interventions

Dietary fiber: 10-25g

Dietary fiber: 5g

Study Details

Brief summary:

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.

Conditions

Dietary Fiber

Study ID

NCT04611217

Start date

Apr 22, 2021

Status verified date

Jun, 2025

Completion date

Aug 1, 2025

Anticipated

Primary completion date

Aug 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 55

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

88 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: High Fiber diet

Group receiving a high fiber diet

other: Low Fiber diet

Control group receiving a low fiber diet

Interventions

Dietary fiber: 10-25g

10-25 g/day of fiber

Dietary fiber: 5g

5 g/day of fiber

Primary outcome measure

  • Change in microbiome composition and diversity [ Time Frame: Aim 1: On day 1, on 3 separate days during the intervention and on day 28 of the high fiber or low fiber intervention; Aim 2: within 14 days of scheduled colonoscopy visit and on 7 separate days during the intervention ]
  • Short chain fatty acid concentration in plasma [ Time Frame: At the start and the final day on the intervention for both Aims 1 and 2 ]
  • Short chain fatty acids enrichment [ Time Frame: On day 2 and day 21 of the high fiber intervention-only for Aim 2 ]

Central Contacts and Locations

Central contacts

Katherene OB Anguah, PhD

(573)-882-8966anguahk@missouri.edu

Locations

University of Missouri-Columbia

Recruiting

Columbia, Missouri, United States, 65212

Contacts

Principal Investigator:

Katherene O Anguah, Ph.D.

More Information

Sponsor

University of Missouri-Columbia

Last update posted

Jun 22, 2025

Last verified

Jun, 2025

Keywords

  • dietary fiber
  • satiety
  • microbiome
  • short chain fatty acids
  • functional magnetic resonance imaging
  • cardiometabolic risk

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Missouri-Columbia on 2025-06-22.