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High-Fiber Diet for Satiety (FEMS Trial)

N/A
Recruiting
Research Sponsored by University of Missouri-Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 20-55y (Aim 1); 45-55y (Aim 2)
A large waistline: 35 inches or more for women 40 inches or more for men
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights

FEMS Trial Summary

This trial will test the effect of a high-fiber diet on appetite, satiety, and cardiometabolic health in overweight/obese subjects, and whether elevated short-chain fatty acid concentration mediates improved satiety.

Who is the study for?
This trial is for overweight/obese men and women aged 20-55 with a large waistline, stable weight, pre-diabetes or high cholesterol who are not on special diets or taking medications affecting appetite or the microbiome. They must be willing to eat a research diet and provide blood and fecal samples.Check my eligibility
What is being tested?
The study tests how different amounts of dietary fiber from peas affect feelings of fullness, heart health markers, glucose regulation, and gut microbes in participants. One group will consume a high-fiber diet while another consumes less fiber over several weeks.See study design
What are the potential side effects?
Potential side effects may include digestive changes like bloating or gas due to increased fiber intake. These are generally mild but can vary between individuals.

FEMS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 20 and 55 years old for Aim 1, or between 45 and 55 for Aim 2.
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My waistline is over 35 inches (women) or 40 inches (men).
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I am a premenopausal woman or a man.
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I am on stable doses of statins, blood pressure, and depression medications that don’t affect my weight or appetite.

FEMS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in microbiome composition and diversity
Short chain fatty acid concentration in plasma
Short chain fatty acids enrichment
Secondary outcome measures
Change in appetite hormones (GLP-1 and PYY)
Change in blood oxygenation level dependent (BOLD) response
Glucose and lipids and blood pressure
+1 more

FEMS Trial Design

2Treatment groups
Experimental Treatment
Group I: Low Fiber dietExperimental Treatment1 Intervention
Control group receiving a low fiber diet
Group II: High Fiber dietExperimental Treatment1 Intervention
Group receiving a high fiber diet

Find a Location

Who is running the clinical trial?

University of Missouri-ColumbiaLead Sponsor
360 Previous Clinical Trials
627,876 Total Patients Enrolled

Media Library

Dietary fiber Clinical Trial Eligibility Overview. Trial Name: NCT04611217 — N/A
Dietary Fibers Research Study Groups: High Fiber diet, Low Fiber diet
Dietary Fibers Clinical Trial 2023: Dietary fiber Highlights & Side Effects. Trial Name: NCT04611217 — N/A
Dietary fiber 2023 Treatment Timeline for Medical Study. Trial Name: NCT04611217 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What measurable results are researchers expecting from this medical experiment?

"This medical study has two primary goals. The first is to analyse changes in composite microbiome and diversity over a specified time period. Secondary objectives include the assessment of brain activation via blood oxygenation level dependent response, self-reported appetite through visual analogue scales at various intervals, and levels of GLP-1 and PYY hormones present in the bloodstream drawn from patients on different days."

Answered by AI

How many people are involved in this medical trial?

"Affirmatively, the information on clinicaltrials.gov demonstrates that this research is presently enrolling volunteers; it was initially published in April 2021 and edited most recently in October of the same year. This study necessitates 88 individuals from single location to participate."

Answered by AI

Is this experiment currently enrolling participants?

"Data on clinicaltrials.gov indicates that this experiment is still recruiting individuals, with its initial posting taking place on April 22nd 2021 and the most recent edit occurring October 20th of this year."

Answered by AI

Who meets the eligibility criteria to participate in this trial?

"This experimental research seeks 88 participants of pre-menopausal age (20 to 55) with a dietary fibre intake falling within the specified range. To be eligible, individuals must have been taking statins, anti-hypertensives and/or antidepressants for some time without altering their appetite or weight; in addition, they should possess at least one characteristic indicative of metabolic syndrome—but no diabetes diagnosis—and cannot have experienced any drastic fluctuations in bodyweight over the last three months."

Answered by AI

Are those aged 50 or above being enrolled for the clinical trial?

"To qualify for this clinical research, participants must be aged between 20 and 55 years."

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~28 spots leftby Aug 2025