Biomarker-estimated Flavanol Intake in Davis (FID)

Study Overview
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Brief Summary
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Flavanols are compounds present in plants, including apples, berries, peaches, cocoa-derived products and certain beverages like tea. Following intake, they are absorbed and broken down into smaller compounds called 'metabolites'. Some of these metabolites are excreted in urine. In this study, we hope to collect urine and examine the metabolites to learn more about the types and amounts of flavanols that people are consuming as part of their usual diet.

Detailed Description
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Flavanols, including the monomers (-)-epicatechin and (+)-catechin, and their related oligomeric derivatives, the procyanidins, are a group of plant-derived, dietary bioactives amply present in the diet. Supported by accumulating epidemiological studies and outcomes from the first large-scale randomized study with bioactives, the COcoa Supplement and Multivitamin Outcomes Study (COSMOS), the Academy of Nutrition and Dietetics released the first dietary recommendation for flavan-3-ols intake in the United States (US). This recommendation suggests the consumption of 400-600 mg/d of flavan-3-ols to mediate cardiometabolic beneficial effects, including the reduction of cardiovascular disease risk. While previous studies have aimed at assessing dietary intake of this group of bioactives, the tools used for these assessments were based on dietary questionnaires and food content databases. These tools are subjective and known to present significant limitations. Recently, our laboratory developed a series of nutritional biomarkers to objectively assess flavanol intake and thus, overcome limitations inherent to previous methods. These biomarkers are based on the quantification of a series of flavanol metabolites, including the 5-(3,4-dihydrophenyl)-γ-valerolactone metabolites (gVLM) and the structurally related (-)-epicatechin metabolites (SREMs). These biomarkers provide complementary information; as while gVLM provide information about the intake of flavanols in general, SREMs are specific biomarkers of (-)-epicatechin intake. In addition, gVLM are surrogate biomarkers, which means that this biomarker allows ranking volunteers from low to high flavanol consumers without providing information on absolute intake. On the other hand, SREMs proved to perform as a recovery biomarker when assessed in 24-hour urine, thus providing absolute amount of (-)-epicatechin consumed. While gVLM and SREM biomarkers have been used to assess the intake of flavanols and epicatechin in the United Kingdom, little is known about biomarker-estimated intake of flavanols in the US, and even less when considering the use of SREM as a recovery biomarker. Therefore, the characterization of flavanol and epicatechin intake in a US population will provide essential information to understand efforts to promote flavanol intake based on current dietary recommendations and thus increase access of the health benefit related to the consumption of these bioactives to the public in general.

Official Title
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Flavanol Intake in Davis (FID) Study: Biomarker-estimated Habitual (-)-Epicatechin and Flavanol Intake in Adults

Conditions
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Adults

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adults in Davis and the greater Sacramento area of California<br>Adults in Davis and the greater Sacramento area of California | Other: No intervention<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarker-estimated (-)-epicatechin and flavanol intake | Biomarker-estimated habitual (-)-epicatechin and flavanol intake assessed as the urinary concentration of SREM and gVLM in 24 hr urine. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subgroup analysis of biomarker-estimated (-)-epicatechin and flavanol intake by age, sex, anthropometric and clinical characteristics | Characterization of biomarker-estimated habitual (-)-epicatechin and flavanol intake (assessed as urinary concentrations of SREM and gVLM in 24 hr urine) by age, sex, anthropometric and clinical (health or disease status) characteristics. | 1 day | 
| Change of biomarker-estimated (-)-epicatechin and flavanol intake as a function of the intake of individual foods | Change of the biomarker-estimated habitual (-)-epicatechin and flavanol intake (assessed as the urinary concentration of SREM and gVLM in 24 hr urine) as a function of the intake of individual foods (assessed by the Automated Self-Administered 24-Hour (ASA24) Dietary Assessment Tool). | 1 day | 
| Change of biomarker-estimated (-)-epicatechin and flavanol intake as a function of diet quality | Change of the biomarker-estimated habitual (-)-epicatechin and flavanol intake (assessed as the urinary concentration of SREM and gVLM in 24 hr urine) as a function of diet quality (assessed by food frequency questionnaire; Diet History Questionnaire III (DHQ III)). | 1 day | 
| Inter-day variation of biomarker-estimated (-)-epicatechin and flavanol intake | Inter-day variation of the biomarker-estimated habitual (-)-epicatechin and flavanol intake (assessed as the urinary concentration of SREM and gVLM in 24 hr urine) in a sub-cohort of volunteers. | 1 day | 
| Biomarker-estimated (-)-epicatechin and flavanol intake in spot urine | Biomarker-estimated habitual (-)-epicatechin and flavanol intake assessed as the urinary concentration of SREM and gVLM in spot urine. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Flavanols, Dietary flavanols, Phytonutrients, Bioactives, Observational, (-)-epicatechin