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High-Fiber Diet for Satiety (FEMS Trial)
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.
FEMS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowFEMS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.FEMS Trial Design
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Who is running the clinical trial?
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- I am between 20 and 55 years old for Aim 1, or between 45 and 55 for Aim 2.My waistline is over 35 inches (women) or 40 inches (men).I have a history of a significant health condition, such as heart disease or HIV.You are willing to follow a special diet during the study.I am not currently taking medications that affect my gut health.I am postmenopausal.Your body mass index (BMI) falls between 25 and 35 kg/m2 for Aim 1, or between 25 and 40 kg/m2 for Aim 2.I am a premenopausal woman or a man.You are eating more than 25g of fiber per day (which is higher than what most people eat) or less than 10g of fiber per day.You are currently using tobacco products.You are following a specific diet, trying to lose weight, or have dietary restrictions (such as being a vegetarian).I am taking medication that affects my appetite or digestion.I am on stable doses of statins, blood pressure, and depression medications that don’t affect my weight or appetite.My BMI is either below 25 or above 35 for Aim 1, and below 25 or above 40 for Aim 2.You have at least one sign of metabolic syndrome, but you do not have diabetes.
- Group 1: High Fiber diet
- Group 2: Low Fiber diet
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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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