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NCT Number: NCT06086145

Biomarker-estimated Flavanol Intake in Davis (FID)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California Davis

Davis, California, 95618, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Biomarker-estimated (-)-epicatechin and flavanol intake

    Time frame: 1 day

    Biomarker-estimated habitual (-)-epicatechin and flavanol intake assessed as the urinary concentration of SREM and gVLM in 24 hr urine.

Secondary outcomes

  1. Subgroup analysis of biomarker-estimated (-)-epicatechin and flavanol intake by age, sex, anthropometric and clinical characteristics

    Time frame: 1 day

    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.

  2. Change of biomarker-estimated (-)-epicatechin and flavanol intake as a function of the intake of individual foods

    Time frame: 1 day

    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).

  3. Change of biomarker-estimated (-)-epicatechin and flavanol intake as a function of diet quality

    Time frame: 1 day

    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)).

  4. Inter-day variation of biomarker-estimated (-)-epicatechin and flavanol intake

    Time frame: 1 day

    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.

  5. Biomarker-estimated (-)-epicatechin and flavanol intake in spot urine

    Time frame: 1 day

    Biomarker-estimated habitual (-)-epicatechin and flavanol intake assessed as the urinary concentration of SREM and gVLM in spot urine.

Other outcomes

  1. Blood pressure

    Time frame: 1 day

    Systolic and diastolic blood pressure will be measured as determined with SphygmoCor® XCEL.

  2. Augmentation index

    Time frame: 1 day

    Augmentation index will be measured as determined with SphygmoCor® XCEL.

  3. Lipid panel

    Time frame: 1 day

    Lipid panel will be assessed using validated methods by a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory.

  4. Other Urine Measures

    Time frame: 1 day

    Sodium, potassium, calcium, specific gravity, urea, creatinine, and urine chemistry.

  5. Other Intake Biomarkers

    Time frame: 1 day

    Magnesium, vitamin C, methylxanthines, sugar intake biomarkers, fiber/whole grain intake biomarkers, polyphenol intake biomarkers (hippuric acids) and meat intake biomarkers (methylhistidines).

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • Mars, Inc.

Registry information

Official study title

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

Acronym: FID

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 17, 2023
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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