Absorption and Metabolism of Dietary Cocoa Procyanidins in Humans

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT01483508
First received: November 28, 2011
Last updated: October 23, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Healthy
Other: Flavanol- and procyanidins-containing drink
Other: Procyanidins-containing drink
Other: Flavanol-containing drink

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Contribution of Dietary Cocoa Procyanidins to the Systemic Presence of Flavanols Metabolites in Humans

Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • Peak plasma concentration of flavanol metabolites [ Time Frame: After consumption at time points 0, 1, 2 and 4 h ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Amount of flavanol metabolites excreted in urine [ Time Frame: urine collected up to 24h post-consumption ] [ Designated as safety issue: No ]
    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.

  • Amount of 5-(3,4-dihydroxyphenyl)-gamma-valerolactone metabolites in urine [ Time Frame: urine collected up to 24 h post-consumption ] [ Designated as safety issue: No ]
    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.


Enrollment: 12
Study Start Date: February 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Cocoa-based dairy drink
Experimental: Flavanols only Other: Flavanol-containing drink
Single oral intake of a cocoa-based dairy drink containing flavanols [monomers]
Other Name: 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 Name: Cocoa-based dairy drink

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01483508

Locations
United States, California
Ragle Facility-UC Davis
Davis, California, United States, 95616
Sponsors and Collaborators
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01483508     History of Changes
Other Study ID Numbers: 200513038
Study First Received: November 28, 2011
Last Updated: October 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
flavanols
procyanidins
absorption
cocoa polyphenols
Flavanol and procyanidin absorption in healthy volunteers

Additional relevant MeSH terms:
Procyanidin
Proanthocyanidin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2014