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Absorption and Metabolism of Dietary Cocoa Procyanidins in Humans

NCT ID: NCT01483508

Last Updated: 2012-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-08-31

Brief Summary

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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.

Detailed Description

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Flavanols and their oligomeric derivatives, the procyanidins, are plant-derived compounds normally present in the human diet. Accumulating data demonstrate a causal role for flavanols in mediating the cardiovascular benefits associated with the consumption of flavanol-/procyanidin-containing foods. Evidence for a direct, causal role for procyanidins in this context is far less profound. As this is often based on the poor absorption of procyanidins, it has been proposed that procyanidins may indirectly contribute to the systemic presence of bioactive compounds via derivatives generated from the breakdown or catabolism of procyanidins in the gastrointestinal tract. These postulated 'breakdown products' include: i) flavanols, putatively generated by acid hydrolysis in the stomach, and ii) series of phenolic compounds, including 5-(3,4-dihydroxyphenyl)-gamma-valerolactone, that are produced from procyanidin catabolism by the gut microbiome. Verification or rejection of these suppositions could significantly impact the interpretation of epidemiological-/dietary intervention data, and the design of food-content data bases. To address this question, healthy volunteers will consume specially designed cocoa-based dairy drinks containing flavanols and procyanidins (dimers to decamers) either together or individually.

Conditions

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Healthy

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Flavanol and procyanidins

Group Type ACTIVE_COMPARATOR

Flavanol- and procyanidins-containing drink

Intervention Type OTHER

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

Flavanols only

Group Type EXPERIMENTAL

Flavanol-containing drink

Intervention Type OTHER

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

Procyanidins only

Group Type EXPERIMENTAL

Procyanidins-containing drink

Intervention Type OTHER

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

Interventions

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Flavanol- and procyanidins-containing drink

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

Intervention Type OTHER

Procyanidins-containing drink

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

Intervention Type OTHER

Flavanol-containing drink

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

Intervention Type OTHER

Other Intervention Names

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Cocoa-based dairy drink Cocoa-based dairy drink cocoa-based dairy drink

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carl L Keen, PhD

Role: STUDY_CHAIR

Department of Nutition, University of California Davis

Javier I Ottaviani, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Nutrition, University of California Davis

Locations

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Ragle Facility-UC Davis

Davis, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 20852295 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15640486 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20854839 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12399286 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12324293 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14556848 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22378733 (View on PubMed)

Other Identifiers

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200513038

Identifier Type: -

Identifier Source: org_study_id