Dietary Fiber Effects on the Microbiome and Satiety

NCT04611217 | Recruiting

• 1 other identifier: 2025807
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

Strong evidence supports the association between high fiber (HiFi) diets (e.g. legumes, nuts, vegetables) and a reduced risk for chronic conditions such as cardiovascular disease (CVD), type 2 diabetes and some forms of cancer. However, the current U.S. average consumption of dietary fiber of 17g/day is significantly below the recommendation level of 25g/d for women and 38g/d for men. Furthermore, fiber fermentation to produce short chain fatty acid (SCFA) products and alterations in microbial composition and activity may be mechanisms linking a HiFi diet to improved health. Importantly, much of the data, including findings supporting a beneficial role of SCFA have been derived from animal studies. Human studies are now needed to advance the understanding of the translational significance of rodent studies and the potential benefit of fiber on microbial metabolites and cardiometabolic health, glucose regulation, appetite and satiety. The central hypothesis is that that the mechanisms by which dietary fiber provides metabolic benefit include direct physical effects in the upper gastrointestinal tract to slow nutrient absorption, and indirect effects to reduce food intake mediated by SCFA-induced secretion of intestinal hormones resulting in increased satiety. Design: Using fiber derived from peas, Aim 1 will test the effect of a HiFi diet on appetite, satiety, and cardiometabolic health and whether elevated SCFA concentration mediates improved satiety in 44 overweight/obese subjects randomly assigned to receive either a high fiber or a low fiber dietary intervention for four weeks in a parallel arm-repeated measures design. Aim 2 will quantitate the changes in microbial composition and colonic SCFA production rate during HiFi feeding and whether any changes are potential mediators of observed benefits on satiety and cardiometabolic risk factors in 26 subjects assigned to receive a high fiber intervention for 3 weeks in a repeated measures design. Relevance: These studies will significantly expand the understanding of mechanisms by which dietary fiber improves satiety and cardiometabolic health in humans.

Conditions

Dietary Fiber

Keywords

dietary fiber; satiety; microbiome; short chain fatty acids; functional magnetic resonance imaging; cardiometabolic risk

Outcome Measures

Primary Outcomes (3)

• Change in microbiome composition and diversity

  Fecal samples are collected on different days during the intervention for microbiome analyses using 16rRNA technique

  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

• Short chain fatty acid concentration in plasma

  Plasma SCFA are analyzed using gas chromatography/mass spectrometry (GC/MS)

  At the start and the final day on the intervention for both Aims 1 and 2

• Short chain fatty acids enrichment

  Subjects are infused with stable isotopes of the short chain fatty acids, acetate, propionate, and butyrate and then isotope dilution by an unlabeled fiber fromt he diet is used to quantify the levels of acetate, propionate and butyrate in vivo

  On day 2 and day 21 of the high fiber intervention-only for Aim 2

Secondary Outcomes (4)

• Change in blood oxygenation level dependent (BOLD) response

  Aim 1: On day 1 and day 28 of the high fiber or low fiber intervention

• Subjective appetite

  Aim 1: On day 1 and day 28 of the high fiber or low fiber intervention. Aim 2: On day 2 and day 21 of the high fiber intervention

• Glucose and lipids and blood pressure

  Aim 1: On day 1 and day 28 of the high fiber or low fiber intervention. Aim 2: On day 2 and day 21 of the high fiber intervention

• Change in appetite hormones (GLP-1 and PYY)

  Aim 1: On day 1 and day 28 of the high fiber or low fiber intervention. Aim 2: On day 2 and day 21 of the high fiber intervention

Study Arms (2)

High Fiber diet

EXPERIMENTAL

Group receiving a high fiber diet

Other: Dietary fiber: 10-25g

Low Fiber diet

OTHER

Control group receiving a low fiber diet

Other: Dietary fiber: 5g

Interventions

Dietary fiber: 10-25g OTHER

10-25 g/day of fiber

High Fiber diet

Dietary fiber: 5g OTHER

5 g/day of fiber

Low Fiber diet

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women (premenopausal only)
• Age 20-55y (Aim 1); 45-55y (Aim 2)
• BMI ≥25 or ≤35 kg/m2 (Aim 1); ≥25 or ≤40 (Aim 2)
• Weight stable (no fluctuations in body weight of greater than 4 kg in the last 3 months)
• Willing to consume a research diet
• Willing to provide blood and fecal samples
• At least one characteristic of the metabolic syndrome (but not diabetic)
• \. A large waistline: 35 inches or more for women 40 inches or more for men 2. High triglycerides: 150 mg/dL or higher 3. Low HDLc level: \<50 mg/dL for women \<40 mg/dL for men 4. High blood pressure ≥130/85 mmHg 5. Fasting blood sugar ≥100 mg/dL
• Pre-diabetes acceptable (glucose \<125 mg/dL or HbA1c \<6.5%)
• Stably treated with statin drugs, anti-hypertensives, and anti-depressants. These are acceptable as long as the drug category does not alter appetite, body weight, or the microbiome (if known)

You may not qualify if:

• Pregnant or lactating
• Postmenopausal (evidence suggests an interplay between the gut microbiome)
• BMI of \<25 or \>35 kg/m2 (Aim 1); \<25 or \>40 kg/m2 (Aim 2)
• Use of medications that affect the gut microbiome (e.g. antibiotics)
• Taking medications known to affect appetite (e.g., phentermine) or gastrointestinal function (e.g., metformin)
• On a special diet or undergoing weight loss, vegetarian, or other restricted dietary patterns
• Ad libitum intake of fiber above 25g/day (mean intake in the US population is 17g/day) and \< 10g/d
• Ad libitum alcohol intake of greater than 1 drink/d for women and 2 drinks/d for men
• History of disease (example colon cancer, HIV, cardiovascular disease, psychiatric disorders, etc.)
• Use of tobacco products
• Having metal or implants in the body that are not MRI compatible (Aim 1 only)

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri-Columbia

Columbia, Missouri, 65212, United States

RECRUITING

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MeSH Terms

Interventions

Dietary Fiber

Intervention Hierarchy (Ancestors)

Dietary Carbohydrates; Carbohydrates; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Katherene OB Anguah, PhD

CONTACT

(573)-882-8966; anguahk@missouri.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Aim 1- Participants are blinded to the treatment arm. The high fiber and low fiber foods are matched in palatability, appearance and energy. Laboratory staff will be blinded to the subject's diet assignment (SA1), all biochemistries, and the microbiome analysis (samples are identified by code and batch processed, all baseline and follow-up samples analyzed simultaneously).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Nutrition & Exercise Phys-HES

Model Details: Aim 1- 4-week parallel arm repeated measures Aim 2- 3 week single arm repeated measures

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: November 2, 2020
• Study Start: April 22, 2021
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)