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Completed

NCT Number: NCT01483508

Absorption and Metabolism of Dietary Cocoa Procyanidins 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.

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ragle Facility-UC Davis

Davis, California, 95616, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Flavanol- and procyanidins-containing drink

Other

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

Other names: Cocoa-based dairy drink

Procyanidins-containing drink

Other

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

Other names: Cocoa-based dairy drink

Flavanol-containing drink

Other

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

Other names: cocoa-based dairy drink

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Dec 1, 2011
Registry last updated
Oct 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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