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Completed

NCT Number: NCT01790009

Influence of Age on the Absorption and Metabolism of Cocoa Flavanols

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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Key information

Conditions

Healthy

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Department of Food and Nutritional Sciences

Reading, Berkshire, RG6 6AP, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Flavanol rich drink

Dietary Supplement

Other names: Comparison of two different doses of a flavanol rich drink

Acetaminophen

Drug

2x500 mg Acetaminophen

Other names: Paracetamol

Primary outcomes

  1. Plasma and urine flavanol metabolites

    Time frame: 24 hours

Secondary outcomes

  1. Paracetamol and methylxanthine plasma and urine levels

    Time frame: 24 h

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Feb 12, 2013
Registry last updated
Feb 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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