Influence of Age on the Absorption and Metabolism of Cocoa Flavanols

Study Overview
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Brief Summary
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Accumulating evidence suggests that regular consumption of foods and beverages rich in flavanols, such as cocoa, tea, apples and wine, may have cardiovascular benefits. Several well-controlled randomised human intervention studies have shown that cocoa flavanols have beneficial effects on blood pressure, endothelial function and other biomarkers of cardiovascular health. These vascular improvements have been correlated in time with changes in plasma flavanol metabolites. The health benefits of flavanol consumption are therefore likely dependent on changes in their absorption, distribution, metabolism and excretion (ADME). Recent studies have provided detailed information regarding the absorption and metabolism of cocoa flavanols. However, there is a lack of information on whether there are changes in flavanol absorption and metabolism with increasing age.

Official Title
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Influence of Age on the Absorption and Metabolism of Cocoa Flavanols

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Flavanol rich drink
* Drug: Acetaminophen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: signed consent form Caucasian Good general health No allergy to milk products or sensitivity to alkaloids/caffeine, No gastrointestinal disorders (e.g., chronic constipation, diarrhoea, inflammatory bowel disease, irritable bowel syndrome, or other chronic gastrointestinal complaints) Not diabetic or suffering from hypertension (140/90 mm Hg), No anaemia or gall bladder problems. Exclusion Criteria: those on a weight reducing dietary regimen Taking any dietary supplements Consuming more than 15 units (120g) of alcohol per week Taking anti-inflammatory medication Smokers Those with sensitivities to chocolate, reduced calorie sweeteners, dairy, nuts or gluten, Vegetarians or vegans.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Flavanol Rich drink<br>Flavanol-rich drink containing 800 mg/75 Kg of Body Weight (BW) | Dietary Supplement: Flavanol rich drink<br> <br> * Other names: Comparison of two different doses of a flavanol rich drink;|
| Active Comparator: Flavanol rich drink<br>Flavanol Intervention drink 400 mg/75 Kg BW | Dietary Supplement: Flavanol rich drink<br> <br> * Other names: Comparison of two different doses of a flavanol rich drink;|
| Active Comparator: Acetaminophen<br>2 tabletsx500 mg | Drug: Acetaminophen<br>* 2x500 mg Acetaminophen<br>* Other names: Paracetamol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma and urine flavanol metabolites |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Paracetamol and methylxanthine plasma and urine levels |  | 24 h | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Age, ADME, Flavanols, Pharmacokinetics