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New treatment option for Dietary Fiber
Official title Dietary Fiber Effects on the Microbiome and Satiety
ClinicalTrials.gov ID: NCT04611217
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 55. Healthy volunteers may be eligible.
You may be able to join 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
You likely can't join if
- Pregnant or lactating
- Postmenopausal (evidence suggests an interplay between the gut microbiome)
- BMI of \ 35 kg/m2 (Aim 1); \ 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
See the full eligibility 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...
- 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)
- Pregnant or lactating
- Postmenopausal (evidence suggests an interplay between the gut microbiome)
- BMI of \ 35 kg/m2 (Aim 1); \ 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)
The study team makes the final eligibility decision.
Where it's taking place
- Columbia, Missouri, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbia, Missouri, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.