Examining flavanol intake through urine analysis
Flavanol Intake in Davis (FID) Study: Biomarker-estimated Habitual (-)-Epicatechin and Flavanol Intake in Adults
This study is testing how much flavanol people aged 25 to 75 are getting from their diet by looking at their urine samples to see if it can help us understand its health benefits.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 25 Years to 75 Years |
| Sex | All |
| Sponsor | University of California, Davis Academic / other |
| Locations | 1 site (Davis, California) |
| Trial ID | NCT06086145 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess dietary flavanol intake in adults by analyzing urine samples for flavanol metabolites. Flavanols are plant-derived compounds found in foods like apples, berries, and cocoa, which are believed to have cardiometabolic benefits. The study utilizes newly developed nutritional biomarkers to provide an objective measurement of flavanol consumption, overcoming limitations of traditional dietary assessment methods. Participants will be aged 25 to 75 and will provide urine samples to help quantify their flavanol intake.
Who should consider this trial
Good fit: Ideal candidates are adults aged 25 to 75 with a BMI between 18.5 and 34.9.
Not a fit: Patients with a BMI of 35 or higher, or those with certain gastrointestinal conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved dietary recommendations for flavanol intake, potentially enhancing cardiovascular health.
How similar studies have performed: Previous studies have shown promise in assessing dietary bioactives, but this approach using objective biomarkers is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * 25 - 75 years old * Male or female * BMI 18.5 - 34.9 kg/m2 * Weight ≥ 110 pounds * Computer, tablet or smart phone with cellular data/Wi-Fi to establish video call communication Exclusion criteria: * Adults unable to consent * Prisoners * Non-English speaking\* * BMI ≥ 35 kg/m2 * Indications of substance or alcohol abuse within the last 3 years * Cancer of the GI tract, previous GI surgery (except appendectomy) or GI stoma * History of difficult blood draws * Diarrhea, defined as 3 or more loose or liquid stools/day, within the last 3 months or antibiotic intake within the last 3 months * Currently participating in a clinical or dietary intervention study * Non-English speaking volunteers will be excluded for safety reasons, as we do not have staff that can adequately provide interpretation services that can explain and answer questions with regard to study procedures.
Where this trial is running
Davis, California
- University of California Davis — Davis, California, United States (Recruiting)
Study contacts
- Principal investigator: Francene M. Steinberg, PhD, RD — University of California, Davis
- Study coordinator: Javier I Ottaviani, PhD
- Email: jottaviani@ucdavis.edu
- Phone: (530) 752-3548
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.