Influence of Age on the Absorption and Metabolism of Cocoa Flavanols

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-06-30

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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Flavanol Rich drink

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

Group Type ACTIVE_COMPARATOR

Flavanol rich drink

Intervention Type DIETARY_SUPPLEMENT

Flavanol rich drink

Flavanol Intervention drink 400 mg/75 Kg BW

Group Type ACTIVE_COMPARATOR

Flavanol rich drink

Intervention Type DIETARY_SUPPLEMENT

Acetaminophen

2 tabletsx500 mg

Group Type ACTIVE_COMPARATOR

Acetaminophen

Intervention Type DRUG

2x500 mg Acetaminophen

Interventions

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Flavanol rich drink

Intervention Type DIETARY_SUPPLEMENT

Acetaminophen

2x500 mg Acetaminophen

Intervention Type DRUG

Other Intervention Names

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Comparison of two different doses of a flavanol rich drink Paracetamol

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes