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Absorption and Metabolism of Dietary Cocoa Procyanidins in Humans

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ClinicalTrials.gov Identifier: NCT01483508
Recruitment Status : Completed
First Posted : December 1, 2011
Last Update Posted : October 25, 2012
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Tracking Information
First Submitted Date  ICMJE November 28, 2011
First Posted Date  ICMJE December 1, 2011
Last Update Posted Date October 25, 2012
Study Start Date  ICMJE February 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 29, 2011)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2011)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Absorption and Metabolism of Dietary Cocoa Procyanidins in Humans
Official Title  ICMJE Contribution of Dietary Cocoa Procyanidins to the Systemic Presence of Flavanols Metabolites in Humans
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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
  • Other: Procyanidins-containing drink
    Single oral intake of a ocoa-based dairy drink containing procyanidins [dimers to decamers]
    Other Name: Cocoa-based dairy drink
  • Other: Flavanol-containing drink
    Single oral intake of a cocoa-based dairy drink containing flavanols [monomers]
    Other Name: cocoa-based dairy drink
Study Arms  ICMJE
  • Active Comparator: Flavanol and procyanidins
    Intervention: Other: Flavanol- and procyanidins-containing drink
  • Experimental: Flavanols only
    Intervention: Other: Flavanol-containing drink
  • Experimental: Procyanidins only
    Intervention: Other: Procyanidins-containing drink
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 29, 2011)
12
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01483508
Other Study ID Numbers  ICMJE 200513038
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, Davis
Study Sponsor  ICMJE University of California, Davis
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account University of California, Davis
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP