What side effects are associated with this type of intervention?

Common treatments involving dietary fibers, such as high fiber diets including legumes, nuts, and vegetables, are generally well-tolerated. However, they can cause gastrointestinal side effects like bloating, gas, and abdominal discomfort, especially when fiber intake is increased rapidly. These side effects are typically due to the fermentation of fiber by gut bacteria, leading to increased production of gases. Gradually increasing fiber intake and ensuring adequate hydration can help mitigate these symptoms.

What prior FDA approvals exist?

There are no specific FDA-approved drugs solely for the treatment of dietary fibers aimed at increasing SCFA production and altering microbial composition. However, dietary fibers themselves, such as those found in whole grains, legumes, nuts, and vegetables, are widely recommended for their health benefits, including improved satiety, cardiometabolic health, and reduced risk of chronic diseases. These benefits are partly due to the fermentation of fibers into SCFAs and the positive changes in gut microbiota composition.

What other types of research exist?

Promising novel alternatives to a high fiber diet for patients considering treatment in 2024 include fecal microbiota transplantation (FMT) and the use of synbiotics. FMT has shown cure rates ranging from 70 to 90 percent for recurrent Clostridioides difficile infection, and synbiotics have demonstrated benefits in conditions like eczema and asthma by improving microbial composition and reducing inflammation.

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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

Must not have

BMI of <25 or >35 kg/m2 (Aim 1); <25 or >40 kg/m2 (Aim 2)

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

No Placebo-Only Group

Summary

This trial is testing a high fiber diet made from peas on overweight/obese adults and those with metabolic syndrome. The diet aims to slow nutrient absorption and produce substances in the gut that increase fullness and improve health. Pea fiber has been studied for its potential to improve weight control and metabolic health in overweight and obese adults.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My BMI is either below 25 or above 35 for Aim 1, and below 25 or above 40 for Aim 2.

Timeline

Screening ~ 3 weeks3 visits

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in microbiome composition and diversity

Short chain fatty acid concentration in plasma

Short chain fatty acids enrichment

Secondary study objectives

Change in appetite hormones (GLP-1 and PYY)

Change in blood oxygenation level dependent (BOLD) response

Glucose and lipids and blood pressure

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Dietary fibers, particularly from high fiber diets, work through several mechanisms to improve health. They are fermented by gut bacteria to produce short-chain fatty acids (SCFAs), which play a role in regulating appetite and satiety by inducing the secretion of intestinal hormones. Additionally, dietary fibers alter the microbial composition in the gut, promoting the growth of beneficial bacteria. These changes can slow nutrient absorption in the upper gastrointestinal tract, reduce food intake, and improve cardiometabolic health. For patients, these mechanisms are crucial as they link high fiber intake to reduced risks of chronic conditions such as cardiovascular disease, type 2 diabetes, and certain cancers.

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