Absorption and Metabolism of Dietary Cocoa Procyanidins in Humans

NCT01483508 | Completed

• 1 other identifier: 200513038
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether or not the intake of dietary procyanidins (oligomers of flavanols) contribute to the systemic presence of flavanols in healthy humans.

Conditions

Healthy

Keywords

flavanols; procyanidins; absorption; cocoa polyphenols; Flavanol and procyanidin absorption in healthy volunteers

Outcome Measures

Primary Outcomes (2)

• Area under the curve described by the concentration of flavanol metabolites in plasma versus time

  The concentration of flavanol metabolites in plasma is expressed in nmol/L. Flavanol metabolites encompass a series of O-sulfonated, O-glucuronidated and O-methylated flavanol derivatives generated in the gastrointestinal tract and liver after flavanol absorption.

  After consumption at time points 0, 1, 2 and 4 h

• Peak plasma concentration of flavanol metabolites

  The concentration of flavanol metabolites in plasma is expressed in nmol/L. Flavanol metabolites encompass a series of O-sulfonated, O-glucuronidated and O-methylated flavanol derivatives generated in the gastrointestinal tract and liver after flavanol absorption.

  After consumption at time points 0, 1, 2 and 4 h

Secondary Outcomes (2)

• Amount of flavanol metabolites excreted in urine

  urine collected up to 24h post-consumption

• Amount of 5-(3,4-dihydroxyphenyl)-gamma-valerolactone metabolites in urine

  urine collected up to 24 h post-consumption

Study Arms (3)

Flavanol and procyanidins

ACTIVE COMPARATOR

Other: Flavanol- and procyanidins-containing drink

Flavanols only

EXPERIMENTAL

Other: Flavanol-containing drink

Procyanidins only

EXPERIMENTAL

Other: Procyanidins-containing drink

Interventions

Flavanol- and procyanidins-containing drink OTHER

Single oral intake of a cocoa-based dairy drink containing flavanols \[monomer\] and procyanidins \[dimers to decamers\]

Also known as: Cocoa-based dairy drink

Flavanol and procyanidins

Procyanidins-containing drink OTHER

Single oral intake of a ocoa-based dairy drink containing procyanidins \[dimers to decamers\]

Also known as: Cocoa-based dairy drink

Procyanidins only

Flavanol-containing drink OTHER

Single oral intake of a cocoa-based dairy drink containing flavanols \[monomers\]

Also known as: cocoa-based dairy drink

Flavanols only

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A normal blood chemistry and liver function
• Fasting blood cholesterol and triglycerides \< 300 mg/dl and \< 3.0 mmol/l, respectively
• BMI \< 30 kg/m2 will be considered.
• Volunteers must be able to read and speak English fluently, and thus, fully understand the researchers, research protocols, and their rights as a research volunteer.

You may not qualify if:

• A history of cardiovascular disease, stroke, uncontrolled hypertension (\> 160/90 mm), renal, hepatic, or thyroid disease, GI tract disorders, previous GI surgery, metabolic syndrome, diabetes, taking cholesterol-lowering medication, hormone replacement therapy, antioxidant supplements, on aspirin therapy or taking anticoagulants, or on a medically prescribed diet.
• A history of psychiatric illness or an allergy to peanuts.

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

Ragle Facility-UC Davis

Davis, California, 95616, United States

Location

Related Publications (7)

• Heiss C, Keen CL, Kelm M. Flavanols and cardiovascular disease prevention. Eur Heart J. 2010 Nov;31(21):2583-92. doi: 10.1093/eurheartj/ehq332. Epub 2010 Sep 18.

  PMID: 20852295 BACKGROUND

• Manach C, Williamson G, Morand C, Scalbert A, Remesy C. Bioavailability and bioefficacy of polyphenols in humans. I. Review of 97 bioavailability studies. Am J Clin Nutr. 2005 Jan;81(1 Suppl):230S-242S. doi: 10.1093/ajcn/81.1.230S.

  PMID: 15640486 BACKGROUND

• Crozier A, Del Rio D, Clifford MN. Bioavailability of dietary flavonoids and phenolic compounds. Mol Aspects Med. 2010 Dec;31(6):446-67. doi: 10.1016/j.mam.2010.09.007. Epub 2010 Sep 18.

  PMID: 20854839 BACKGROUND

• Rios LY, Bennett RN, Lazarus SA, Remesy C, Scalbert A, Williamson G. Cocoa procyanidins are stable during gastric transit in humans. Am J Clin Nutr. 2002 Nov;76(5):1106-10. doi: 10.1093/ajcn/76.5.1106.

  PMID: 12399286 BACKGROUND

• Holt RR, Lazarus SA, Sullards MC, Zhu QY, Schramm DD, Hammerstone JF, Fraga CG, Schmitz HH, Keen CL. Procyanidin dimer B2 [epicatechin-(4beta-8)-epicatechin] in human plasma after the consumption of a flavanol-rich cocoa. Am J Clin Nutr. 2002 Oct;76(4):798-804. doi: 10.1093/ajcn/76.4.798.

  PMID: 12324293 BACKGROUND

• Gonthier MP, Donovan JL, Texier O, Felgines C, Remesy C, Scalbert A. Metabolism of dietary procyanidins in rats. Free Radic Biol Med. 2003 Oct 15;35(8):837-44. doi: 10.1016/s0891-5849(03)00394-0.

  PMID: 14556848 BACKGROUND

• Ottaviani JI, Kwik-Uribe C, Keen CL, Schroeter H. Intake of dietary procyanidins does not contribute to the pool of circulating flavanols in humans. Am J Clin Nutr. 2012 Apr;95(4):851-8. doi: 10.3945/ajcn.111.028340. Epub 2012 Feb 29.

  PMID: 22378733 DERIVED

Study Officials

• Carl L Keen, PhD

  Department of Nutition, University of California Davis

  STUDY CHAIR

• Javier I Ottaviani, PhD

  Department of Nutrition, University of California Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2011
• First Posted: December 1, 2011
• Study Start: February 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: October 25, 2012

Record last verified: 2012-10

Locations

US (1)