High-Fiber Diet for Satiety

(FEMS Trial)

Overseen By Katherene OB Anguah, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Missouri-Columbia

Must not be taking: Antibiotics, Appetite suppressants

Disqualifiers: Pregnant, Postmenopausal, Special diet, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

88 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how a high-fiber diet affects feelings of fullness and overall heart health. Researchers seek to determine if consuming more fiber, such as peas, helps individuals feel full longer and reduces the risk of heart conditions by altering gut bacteria. Participants will follow either a high-fiber or a low-fiber diet to observe the different impacts. Ideal candidates are those who are overweight or obese, have a stable weight, and show signs of metabolic syndrome (such as a large waistline or high blood pressure) but are not diabetic. As an unphased trial, this study offers participants the opportunity to contribute to groundbreaking research on diet and health.

Will I have to stop taking my current medications?

The trial allows participants to continue taking statin drugs, anti-hypertensives, and anti-depressants as long as they do not affect appetite, body weight, or the microbiome. However, you cannot take medications that affect the gut microbiome or appetite.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that high-fiber diets are generally safe and manageable for most people. Psyllium, a common type of fiber, often aids digestion and helps control blood sugar levels. Studies have found that psyllium can increase feelings of fullness between meals without causing serious side effects.

Some individuals might experience mild digestive issues, such as gas or bloating, but these typically resolve quickly. Overall, a high-fiber diet is associated with numerous health benefits, including better appetite control and lower cholesterol levels. This suggests that increasing fiber intake is a safe choice for most people seeking to improve their health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the high-fiber diet because it could naturally enhance satiety, or the feeling of fullness, without the need for medications. Unlike standard treatments that might involve appetite suppressants or weight loss drugs, a high-fiber diet leverages the natural ability of fiber to expand in the stomach, helping people feel full with fewer calories. This approach not only supports weight management but also promotes overall digestive health, making it a safe and holistic alternative to more conventional options.

What evidence suggests that a high-fiber diet could be effective for improving satiety?

This trial will compare the effects of a high-fiber diet with a low-fiber diet. Studies have shown that a high-fiber diet can promote fullness and reduce calorie intake. Research indicates that fiber, such as psyllium, effectively reduces hunger and prolongs satiety. In individuals who are overweight or obese, fiber supplements have improved feelings of fullness and aided weight loss. Additionally, increased fiber intake is linked to a lower risk of conditions like high blood pressure and high blood sugar, which are components of metabolic syndrome. Overall, a high-fiber diet can aid in weight management and enhance metabolic health. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Fasting blood sugar ≥100 mg/dL

Pre-diabetes acceptable (glucose <125 mg/dL or HbA1c <6.5%)

I am between 20 and 55 years old for Aim 1, or between 45 and 55 for Aim 2.

Exclusion Criteria

Pregnant or lactating

I have a history of a significant health condition, such as heart disease or HIV.

I am not currently taking medications that affect my gut health.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a high fiber or low fiber dietary intervention

4 weeks

Multiple visits for assessments and sample collections

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Microbiome Analysis

Fecal samples are collected for microbiome analyses using 16rRNA technique

Throughout the intervention

What Are the Treatments Tested in This Trial?

Interventions

• Dietary fiber

Trial Overview

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.

How Is the Trial Designed?

Group I: Low Fiber diet Experimental Treatment 1 Intervention

Control group receiving a low fiber diet

Group II: High Fiber diet Experimental Treatment 1 Intervention

Group receiving a high fiber diet

Dietary fiber is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Psyllium for:

• Constipation
• Bowel irregularity
• High cholesterol

Approved in European Union as Ispaghula husk for:

• Constipation
• Bowel irregularity
• Hypercholesterolemia

Approved in Canada as Psyllium for:

• Constipation
• Bowel irregularity
• High cholesterol

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials

387

Recruited

629,000+

Published Research Related to This Trial

The FDA has determined that over-the-counter granular laxatives containing psyllium are not considered safe and effective, leading to their classification as misbranded products.

This decision was influenced by reports of esophageal obstruction linked to the use of these granular laxatives, which occurred despite existing safety warnings and usage instructions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laxative drug products for over-the-counter human use; psyllium ingredients in granular dosage forms. Final rule. [2008]

Guar fiber, or partially hydrolyzed guar gum (PHGG), is an effective appetite control agent that can reduce calorie intake by about 20% in normal subjects when taken at a dose of 2g per serving.

It works by delaying food transit in the colon, stimulating the satiety hormone cholecystokinin (CCK), and enhancing the feeling of fullness after meals, making it a promising ingredient for food and nutritional supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of guar fiber in appetite control. Rao, TP.[2018]

In a study with 14 normal volunteers, a dose of 7.4 g of psyllium significantly reduced feelings of hunger and energy intake after a low-calorie meal, without needing to be mixed into the food.

Psyllium did not delay gastric emptying but instead appeared to improve nutrient absorption in the intestines, leading to lower post-meal spikes in glucose, insulin, and triglycerides.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of psyllium on gastric emptying, hunger feeling and food intake in normal volunteers: a double blind study. Rigaud, D., Paycha, F., Meulemans, A., et al.[2022]

In a clinical study involving 40 patients with cardiovascular disease or severe hypercholesterolemia, a high-fiber diet rich in soluble plant fibers led to significant reductions in total cholesterol (down 20.3%) and APO B levels (down 15.2%) over a period of 3 to 33 weeks.

The diet also improved HDL-cholesterol levels by 7.6% and APO A-I by 10.1%, indicating not only a reduction in harmful cholesterol but also an increase in protective cholesterol, suggesting a beneficial overall impact on heart health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Improvement in blood lipids and lipoproteins by simple nutritional modification, exemplified by a high-fiber modified so-called "heart diet" of a West German clinic: the therapeutic gain due to expanding and high fiber foods]. Pape, D.[2017]

Dietary fibers, particularly pectins and gums, can delay gastric emptying and nutrient absorption, which helps improve glycemic control in diabetes and alleviate constipation.

Insoluble fibers like cellulose and lignins accelerate colonic transit and are effective as laxatives, while also contributing to lower blood cholesterol and increased feelings of fullness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacology of dietary fibre. Spiller, RC.[2019]

In a study involving 340 patients with mild-to-moderate hypercholesterolaemia, ispaghula husk significantly reduced LDL cholesterol levels by 10.6-13.2% when combined with dietary modifications, outperforming placebo.

Ispaghula husk was found to be effective and well tolerated, making it a promising adjunct treatment for managing cholesterol levels in patients with mild-to-moderate hypercholesterolaemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ispaghula husk in the treatment of hypercholesterolaemia: a double-blind controlled study. MacMahon, M., Carless, J.[2017]

Feeding animals large amounts of dry hydrophilic fibers like psyllium husk can cause intestinal obstruction, so these fibers should be hydrated before feeding instead of being given in dry form.

Psyllium has a much higher water-holding capacity than wheat bran, making it more likely to cause intestinal dehydration when consumed dry, suggesting that fiber sources should be given in amounts similar to typical human dietary levels to avoid adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Warning: feeding animals hydrophilic fiber sources in dry diets. Struthers, BJ.[2018]

Increasing dietary fiber, particularly psyllium, may help prevent diseases like diabetes, coronary artery disease, and colonic cancer, contributing to a 30% decline in CAD death rates over the past 15 years.

Psyllium effectively lowers cholesterol levels when used alongside dietary changes and other medications, such as statins, and is well tolerated and cost-effective for patients with mild-to-moderate hypercholesterolemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutriceuticals in cardiovascular disease: psyllium. Petchetti, L., Frishman, WH., Petrillo, R., et al.[2017]

In a study of 75 patients with chronic constipation, treatment with Ispaghula Husk (Fibrolax) for 4 weeks significantly improved stool frequency, consistency, and reduced abdominal pain without any major side effects.

The treatment did not significantly affect cholesterol levels, HDL-cholesterol, or triglycerides, indicating it is a safe option for managing chronic constipation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of chronic constipation by a bulk-forming laxative (Fibrolax). Borgia, M., Sepe, N., Brancato, V., et al.[2017]

A study involving 224 patients with symptomatic hemorrhoids showed significant improvement when treated with a high fiber diet supplemented by ispaghula husk (Metamucil) over a 12-month period.

The findings suggest that conservative treatment with dietary changes alone can be highly effective for managing symptoms of hemorrhoids, indicating a safe and non-invasive approach to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hemorrhoids! Don't call the surgeon yet. Murshid, KR.[2009]

A meta-analysis of six studies involving 354 overweight and obese participants found that psyllium, taken before meals, significantly reduced body weight by an average of 2.1 kg, BMI by 0.8 kg/m², and waist circumference by 2.2 cm over approximately 4.8 months.

Psyllium's effectiveness in promoting weight loss is attributed to its ability to form a viscous gel that slows nutrient absorption, making it a beneficial dietary intervention for managing weight in overweight and obese individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psyllium is a natural nonfermented gel-forming fiber that is effective for weight loss: A comprehensive review and meta-analysis. Gibb, RD., Sloan, KJ., McRorie, JW.[2023]

Citations

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Fiber supplements improve satiety and reduce metabolic syndrome's risk factors in overweight and obese people. There was no change in serum ...

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The fiber in psyllium husk increases feelings of fullness and satiety, which can help reduce overall calorie intake (McRorie et al., 2021). By ...

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Another meta-analysis revealed that increased psyllium consumption caused a weight loss of 3.70 kg in adults [15]. One study show that psyllium ...

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Metamucil (psyllium fiber) is used for constipation, digestive health issues, cholesterol, reducing appetite, and blood sugar levels.

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These results indicate that psyllium supplementation contributes to greater fullness and less hunger between meals.

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Metamucil Premium Blend Sugar-Free Orange Powder

Metamucil's Premium Blend helps relieve constipation, maintain healthy blood sugar levels, lower cholesterol, and control appetite.