Biomarker-estimated Flavanol Intake in Davis (FID)

NCT ID: NCT06086145

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-02
• Study Completion Date: 2026-06-30

Brief Summary

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

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.

Conditions

Healthy; Diet; Adults

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Adults in Davis and the greater Sacramento area of California

Adults in Davis and the greater Sacramento area of California

No intervention

Intervention Type: OTHER

No intervention

Interventions

No intervention

No intervention

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mars, Inc.

INDUSTRY

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francene M. Steinberg, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

University of California Davis

Davis, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Javier I Ottaviani, PhD

Role: CONTACT

jottaviani@ucdavis.edu

(530) 752-3548

Jodi L Ensunsa, MS

Role: CONTACT

jlensunsa@ucdavis.edu

Facility Contacts

Jodi L Ensunsa, MS

Role: primary

jlensunsa@ucdavis.edu

References

Bhagwat, S. and Haytowitz, D.B. (2015). USDA Database for the Proanthocyanidin Content of Selected Foods, Release 2 (2015). Nutrient Data Laboratory, Beltsville Human Nutrition Research Center, ARS, USDA. https://doi.org/10.15482/USDA.ADC/1324621.

Reference Type: BACKGROUND

Bhagwat, S. and Haytowitz, D.B. (2016). USDA Database for the Flavonoid Content of Selected Foods. Release 3.2 (November 2015). Nutrient Data Laboratory, Beltsville Human Nutrition Research Center, ARS, USDA. https://doi.org/10.15482/USDA.ADC/1324465.

Reference Type: BACKGROUND

Raman G, Avendano EE, Chen S, Wang J, Matson J, Gayer B, Novotny JA, Cassidy A. Dietary intakes of flavan-3-ols and cardiometabolic health: systematic review and meta-analysis of randomized trials and prospective cohort studies. Am J Clin Nutr. 2019 Nov 1;110(5):1067-1078. doi: 10.1093/ajcn/nqz178.

Reference Type: BACKGROUND

PMID: 31504087 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 35294962 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 29146101 (View on PubMed)

Ottaviani JI, Fong R, Kimball J, Ensunsa JL, Britten A, Lucarelli D, Luben R, Grace PB, Mawson DH, Tym A, Wierzbicki A, Khaw KT, Schroeter H, Kuhnle GGC. Evaluation at scale of microbiome-derived metabolites as biomarker of flavan-3-ol intake in epidemiological studies. Sci Rep. 2018 Jun 29;8(1):9859. doi: 10.1038/s41598-018-28333-w.

Reference Type: BACKGROUND

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Ottaviani JI, Fong R, Kimball J, Ensunsa JL, Gray N, Vogiatzoglou A, Britten A, Lucarelli D, Luben R, Grace PB, Mawson DH, Tym A, Wierzbicki A, Smith AD, Wareham NJ, Forouhi NG, Khaw KT, Schroeter H, Kuhnle GGC. Evaluation of (-)-epicatechin metabolites as recovery biomarker of dietary flavan-3-ol intake. Sci Rep. 2019 Sep 11;9(1):13108. doi: 10.1038/s41598-019-49702-z.

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Reference Type: BACKGROUND

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Ottaviani JI, Britten A, Lucarelli D, Luben R, Mulligan AA, Lentjes MA, Fong R, Gray N, Grace PB, Mawson DH, Tym A, Wierzbicki A, Forouhi NG, Khaw KT, Schroeter H, Kuhnle GGC. Biomarker-estimated flavan-3-ol intake is associated with lower blood pressure in cross-sectional analysis in EPIC Norfolk. Sci Rep. 2020 Oct 21;10(1):17964. doi: 10.1038/s41598-020-74863-7.

Reference Type: BACKGROUND

PMID: 33087825 (View on PubMed)

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Document Type: Informed Consent Form

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Other Identifiers

2052789

Identifier Type: -

Identifier Source: org_study_id