High-Fiber Diet for Satiety

(FEMS Trial)

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Missouri-Columbia

Must not be taking: Antibiotics, Appetite suppressants

Disqualifiers: Pregnant, Postmenopausal, Special diet, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the high-fiber diet treatment for satiety?

Research shows that psyllium, a key component of the high-fiber diet, can delay stomach emptying and reduce hunger, which may help people feel fuller for longer. Additionally, psyllium has been effective in weight loss and improving cholesterol levels, suggesting it can support overall health and satiety. ^{1 2 3 4 5}

Is a high-fiber diet using psyllium generally safe for humans?

Psyllium, a type of dietary fiber, is generally safe for humans when used properly, but it should not be consumed in dry granular form as it can cause esophageal obstruction (blockage in the throat). It is important to mix psyllium with liquid before consuming to avoid this risk. In studies, psyllium has been well tolerated with no significant side effects reported. ^{5 6 7 8 9}

How does the high-fiber diet treatment for satiety differ from other treatments?

The high-fiber diet treatment, using psyllium, is unique because it focuses on increasing satiety by delaying gastric emptying and reducing hunger, which can help control appetite and manage weight. Unlike other treatments that may require high doses or have a strong taste, psyllium is effective at a moderate dose and is relatively easy to incorporate into a diet. ^{2 3 5 10 11}

Research Team

Eligibility Criteria

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

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

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

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.

Trial Timeline

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

Treatment Details

Interventions

• Dietary fiber (Behavioural Intervention)

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.

Participant Groups

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 Canada for the following indications:

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+

Mun Y. Choi

University of Missouri-Columbia

Chief Executive Officer since 2017

PhD in Mechanical and Aerospace Engineering from Princeton University

Richard Barohn

University of Missouri-Columbia

Chief Medical Officer since 2020

MD from the University of Missouri-Columbia School of Medicine

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

References

1. India pubmed.ncbi.nlm.nih.gov

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

2. England pubmed.ncbi.nlm.nih.gov

Effect of psyllium on gastric emptying, hunger feeling and food intake in normal volunteers: a double blind study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Pharmacology of dietary fibre. [2019]

4. United States 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. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Ispaghula husk in the treatment of hypercholesterolaemia: a double-blind controlled study. [2017]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. England pubmed.ncbi.nlm.nih.gov

Treatment of chronic constipation by a bulk-forming laxative (Fibrolax). [2017]

8. United States pubmed.ncbi.nlm.nih.gov

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

9. United States pubmed.ncbi.nlm.nih.gov

Nutriceuticals in cardiovascular disease: psyllium. [2017]

10. Switzerland 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]. [2017]

11. United States pubmed.ncbi.nlm.nih.gov

Role of guar fiber in appetite control. [2018]