Biomarker-estimated Flavanol Intake in Davis (FID)

NCT06086145 | Active Not Recruiting

• 1 other identifier: 2052789
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Diet; Adults

Keywords

Flavanols; Dietary flavanols; Phytonutrients; Bioactives; Observational

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

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

  1 day

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

  1 day

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

  1 day

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

  1 day

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

  1 day

Other Outcomes (5)

• Blood pressure

  1 day

• Augmentation index

  1 day

• Lipid panel

  1 day

Study Arms (1)

Adults in Davis and the greater Sacramento area of California

Adults in Davis and the greater Sacramento area of California

Other: No intervention

Interventions

No intervention OTHER

No intervention

Adults in Davis and the greater Sacramento area of California

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Free living adults in Davis and the greater Sacramento area of California.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Davis: lead
• Mars, Inc.: collaborator

Study Sites (1)

University of California Davis

Davis, California, 95618, United States

Location

Related Publications (12)

• 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.

  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.

  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.

  PMID: 31504087 BACKGROUND

• Sesso HD, Manson JE, Aragaki AK, Rist PM, Johnson LG, Friedenberg G, Copeland T, Clar A, Mora S, Moorthy MV, Sarkissian A, Carrick WR, Anderson GL; COSMOS Research Group. Effect of cocoa flavanol supplementation for the prevention of cardiovascular disease events: the COcoa Supplement and Multivitamin Outcomes Study (COSMOS) randomized clinical trial. Am J Clin Nutr. 2022 Jun 7;115(6):1490-1500. doi: 10.1093/ajcn/nqac055.

  PMID: 35294962 BACKGROUND

• Crowe-White KM, Evans LW, Kuhnle GGC, Milenkovic D, Stote K, Wallace T, Handu D, Senkus KE. Flavan-3-ols and Cardiometabolic Health: First Ever Dietary Bioactive Guideline. Adv Nutr. 2022 Dec 22;13(6):2070-2083. doi: 10.1093/advances/nmac105.

  PMID: 36190328 BACKGROUND

• Wang Y, Chung SJ, Song WO, Chun OK. Estimation of daily proanthocyanidin intake and major food sources in the U.S. diet. J Nutr. 2011 Mar;141(3):447-52. doi: 10.3945/jn.110.133900. Epub 2011 Jan 26.

  PMID: 21270367 BACKGROUND

• Bai W, Wang C, Ren C. Intakes of total and individual flavonoids by US adults. Int J Food Sci Nutr. 2014 Feb;65(1):9-20. doi: 10.3109/09637486.2013.832170. Epub 2013 Sep 11.

  PMID: 24020353 BACKGROUND

• Kuhnle GGC. Nutrition epidemiology of flavan-3-ols: The known unknowns. Mol Aspects Med. 2018 Jun;61:2-11. doi: 10.1016/j.mam.2017.10.003. Epub 2017 Nov 16.

  PMID: 29146101 BACKGROUND

• 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.

  PMID: 29959422 BACKGROUND

• 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.

  PMID: 31511603 BACKGROUND

• Ottaviani JI, Borges G, Momma TY, Spencer JP, Keen CL, Crozier A, Schroeter H. The metabolome of [2-(14)C](-)-epicatechin in humans: implications for the assessment of efficacy, safety, and mechanisms of action of polyphenolic bioactives. Sci Rep. 2016 Jul 1;6:29034. doi: 10.1038/srep29034.

  PMID: 27363516 BACKGROUND

• 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.

  PMID: 33087825 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and urine

Study Officials

• Francene M. Steinberg, PhD, RD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: October 17, 2023
• Study Start: November 2, 2023
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)