Intake-dependent Effect of Cocoa Flavanol Absorption, Metabolism and Excretion in Humans

Completed · Not applicable

Conditions studied: Healthy

In brief

A randomized, double-masked and cross-over dietary intervention study in healthy young adult males to evaluate the concentration of F-derived metabolites in plasma and urine after single acute intakes of F-containing drinks on four different test days.

Key facts

Study ID

NCT03201822

Run by

University of California, Davis

People needed

14

Starts

2013-04-01

Expected to finish

2013-05-25

Last updated by the study team

2017-06-28

Who can join

Age: 25 and older, up to 40. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• No prescription medications
• BMI 18.5 - 29.9 kg/m2
• Weight ≥ 110 pounds
• previously consumed cocoa and peanut products, with no adverse reactions

You may not qualify if…

• Adults unable to consent
• Prisoners
• Non-English speaking*
• BMI ≥ 30 kg/m2
• Allergies to nuts, cocoa and chocolate products
• Active avoidance of coffee and caffeinated soft drinks
• Under current medical supervision
• A history of cardiovascular disease, stroke, renal, hepatic, or thyroid disease
• History of clinically significant depression, anxiety or other psychiatric condition
• History of Raynaud's disease
• History of difficult blood draws
• Indications of substance or alcohol abuse within the last 3 years
• Current use of herbal, plant or botanical supplements (multi-vitamin/mineral supplements are allowed)
• Blood Pressure > 140/90 mm Hg
• GI tract disorders, previous GI surgery (except appendectomy)
• Self-reported malabsorption (e.g. difficulty digesting or absorbing nutrients from food, potentially leading to bloating, cramping or gas)
• Diarrhea within the last month, or antibiotic intake within the last month
• Vegetarian, Vegan, food faddists, individuals using non-traditional diets, on a weight loss diet or individual following diets with significant deviations from the average diet
• Metabolic panel results or complete blood counts that are outside of the normal reference range and are considered clinically relevant by the study physician
• Screening LDL ≥ 190 mg/dl for those who have 0-1 major risk factors apart from LDL cholesterol (i.e. family history of premature coronary artery disease (male first degree relative < 55 years; CHD in female first degree relative < 65 years), cigarette smoker, HDL-C ≤ 40 mg/dL)
• Screening LDL ≥ 160 mg/dl for those who have 2 major risk factors apart from LDL cholesterol (i.e. family history of premature coronary artery disease (male first degree relative < 55 years; CHD in female first degree relative < 65 years), cigarette smoker, HDL-C ≤ 40 mg/dL).
• (using NCEP calculator http://hp2010.nhlbihin.net/atpiii/calculator.asp?usertype=prof)
• Screening LDL ≥ 130 mg/dl for those who have 2 major risk factors apart from LDL cholesterol (i.e. family history of premature coronary artery disease (male first degree relative < 55 years; CHD in female first degree relative < 65 years), cigarette smoker, HDL-C ≤ 40 mg/dL), and a Framingham 10-year Risk Score 10-20% (Framingham risk calculated using NCEP calculator http://hp2010.nhlbihin.net/atpiii/calculator.asp?usertype=prof)
• Cold, flu, or upper respiratory condition at screening
• Currently participating in a clinical or dietary intervention study

Where it is running

• UC Davis — Davis, California, United States

Full record on ClinicalTrials.gov

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