Influence of Age on the Absorption and Metabolism of Cocoa Flavanols

University of Reading

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Acetaminophen; Dietary Supplement: Flavanol rich drink

Study type: Interventional

Funder types: Other

Identifiers

NCT01790009

FLAV-AGE01

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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40 participants in 3 patient groups

Flavanol Rich drink

Active Comparator group

Description:

Flavanol-rich drink containing 800 mg/75 Kg of Body Weight (BW)

Treatment:

Dietary Supplement: Flavanol rich drink

Flavanol rich drink

Active Comparator group

Description:

Flavanol Intervention drink 400 mg/75 Kg BW

Treatment:

Dietary Supplement: Flavanol rich drink

Acetaminophen

Active Comparator group

Description:

2 tabletsx500 mg

Treatment:

Drug: Acetaminophen