NCT04611217: FEMS

Dietary Fiber Effects on the Microbiome and Satiety

Recruiting now NA Last updated 22 June 2025

What this trial tests

NA trial testing Dietary fiber: 10-25g in Dietary Fiber in 88 participants. Currently enrolling.

Timeline

22 April 2021

Primary endpoint
1 August 2025

1 August 2025

Quick facts

Lead sponsor	University of Missouri-Columbia
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	88
Start date	22 April 2021
Primary completion	1 August 2025
Estimated completion	1 August 2025
Sites	1 location across United States

Drugs / interventions tested

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

Conditions studied

• Dietary Fiber — all drugs for Dietary Fiber →

Sponsor

University of Missouri-Columbia

Who can join

Adults 20 to 55, any sex, with Dietary Fiber. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Incorporating 25 g/d of Pea Fiber into Food for 4 Wk Reduces Glucose Area under the Curve in Individuals with Overweight and Obesity.
   Ghanaatgar M, Ackah-Swanzy L, Anguah KO. · · 2026 · PMID 41297634 · DOI 10.1016/j.tjnut.2025.11.010