Absorption and Metabolism of Dietary Cocoa Procyanidins in Humans

October 23, 2012 updated by: University of California, Davis

Contribution of Dietary Cocoa Procyanidins to the Systemic Presence of Flavanols Metabolites in Humans

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Davis, California, United States, 95616
        • Ragle Facility-UC Davis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Flavanol and procyanidins
Other: Flavanol- and procyanidins-containing drink
Single oral intake of a cocoa-based dairy drink containing flavanols [monomer] and procyanidins [dimers to decamers]
Other Names:
  • Cocoa-based dairy drink
Experimental: Flavanols only
Other: Flavanol-containing drink
Single oral intake of a cocoa-based dairy drink containing flavanols [monomers]
Other Names:
  • cocoa-based dairy drink
Experimental: Procyanidins only
Other: Procyanidins-containing drink
Single oral intake of a ocoa-based dairy drink containing procyanidins [dimers to decamers]
Other Names:
  • Cocoa-based dairy drink

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the curve described by the concentration of flavanol metabolites in plasma versus time
Time Frame: After consumption at time points 0, 1, 2 and 4 h
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
Time Frame: After consumption at time points 0, 1, 2 and 4 h
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of flavanol metabolites excreted in urine
Time Frame: urine collected up to 24h post-consumption
The amount of flavanol metabolites excreted in urine is expressed in µmol. 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.
urine collected up to 24h post-consumption
Amount of 5-(3,4-dihydroxyphenyl)-gamma-valerolactone metabolites in urine
Time Frame: urine collected up to 24 h post-consumption
The amount of 5-(3,4-dihydroxyphenyl)-gamma-valerolactone metabolites excreted in urine is expressed in µmol. 5-(3,4-dihydroxyphenyl)-gamma-valerolactone metabolites encompass a series of O-sulfonated and O-glucuronidated derivatives generated in the gastrointestinal tract and liver after 5-(3,4-dihydroxyphenyl)-gamma-valerolactone absorption.
urine collected up to 24 h post-consumption

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Investigators

  • Study Chair: Carl L Keen, PhD, Department of Nutition, University of California Davis
  • Principal Investigator: Javier I Ottaviani, PhD, Department of Nutrition, University of California Davis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

November 28, 2011

First Submitted That Met QC Criteria

November 29, 2011

First Posted (Estimate)

December 1, 2011

Study Record Updates

Last Update Posted (Estimate)

October 25, 2012

Last Update Submitted That Met QC Criteria

October 23, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200513038

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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