Influence of Age on the Absorption and Metabolism of Cocoa Flavanols

Phase 1

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Flavanol rich drink; Drug: Acetaminophen

• Registration Number: NCT01790009
• Lead Sponsor: University of Reading

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2013-02
• Study First Submitted: 2013-02-08
• Study First Submitted QC: 2013-02-08
• Last Update Submitted: 2013-02-08
• Study First Posted: 2013-02-12
• Last Update Posted: 2013-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Flavanol Rich drink	Flavanol rich drink	Flavanol-rich drink containing 800 mg/75 Kg of Body Weight (BW)
Flavanol rich drink	Flavanol rich drink	Flavanol Intervention drink 400 mg/75 Kg BW
Acetaminophen	Acetaminophen	2 tabletsx500 mg

Primary Outcome Measures

Name	Time	Method
Plasma and urine flavanol metabolites	24 hours

Secondary Outcome Measures

Name	Time	Method
Paracetamol and methylxanthine plasma and urine levels	24 h

Trial Locations

Locations (1)

Department of Food and Nutritional Sciences; 🇬🇧 Reading, Berkshire, United Kingdom