Effects of dietary fiber on gut health and appetite
Mechanisms Linking Dietary Fiber, the Microbiome and Satiety
This study is testing how eating more fiber affects gut health and feelings of fullness in premenopausal men and women aged 20 to 55.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 20 Years to 55 Years |
| Sex | All |
| Sponsor | University of Missouri-Columbia Academic / other |
| Locations | 1 site (Columbia, Missouri) |
| Trial ID | NCT04611217 on ClinicalTrials.gov |
What this trial studies
This study investigates how high fiber diets impact the microbiome and satiety in premenopausal men and women aged 20-55. Participants will consume varying amounts of dietary fiber while providing blood and fecal samples to assess changes in microbial composition and short chain fatty acid production. The research aims to clarify the relationship between fiber intake, gut health, and metabolic syndrome characteristics, particularly focusing on appetite regulation and glucose metabolism. The findings could help translate animal study results into human health benefits.
Who should consider this trial
Good fit: Ideal candidates are premenopausal men and women aged 20-55 with a BMI between 25 and 35, who exhibit at least one characteristic of metabolic syndrome.
Not a fit: Patients who are pregnant, lactating, or postmenopausal will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved dietary recommendations that enhance gut health and metabolic outcomes for individuals at risk of chronic diseases.
How similar studies have performed: While many animal studies have shown promising results regarding dietary fiber and gut health, human studies exploring these effects are still emerging.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) 1\. 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) Exclusion Criteria: * 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)
Where this trial is running
Columbia, Missouri
- University of Missouri-Columbia — Columbia, Missouri, United States (Recruiting)
Study contacts
- Study coordinator: Katherene OB Anguah, PhD
- Email: anguahk@missouri.edu
- Phone: (573)-882-8966
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.