Absorption and Metabolism of Dietary Cocoa Procyanidins in Humans
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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 |
- 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.
- 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 |
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| United States, California | |
| Ragle Facility-UC Davis | |
| Davis, California, United States, 95616 | |
| 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 May 16, 2013