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Clinical Trials/NCT01790009
NCT01790009
Completed
Phase 1

Influence of Age on the Absorption and Metabolism of Cocoa Flavanols

University of Reading1 site in 1 country40 target enrollmentFebruary 2011

Overview

Phase
Phase 1
Intervention
Acetaminophen
Conditions
Healthy
Sponsor
University of Reading
Enrollment
40
Locations
1
Primary Endpoint
Plasma and urine flavanol metabolites
Status
Completed
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2011
End Date
June 2011
Last Updated
13 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jeremy Paul Edward Spencer

Professor

University of Reading

Eligibility Criteria

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
  • Those with sensitivities to chocolate, reduced calorie sweeteners, dairy, nuts or gluten,
  • Vegetarians or vegans.

Arms & Interventions

Acetaminophen

2 tabletsx500 mg

Intervention: Acetaminophen

Flavanol Rich drink

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

Intervention: Flavanol rich drink

Flavanol rich drink

Flavanol Intervention drink 400 mg/75 Kg BW

Intervention: Flavanol rich drink

Outcomes

Primary Outcomes

Plasma and urine flavanol metabolites

Time Frame: 24 hours

Secondary Outcomes

  • Paracetamol and methylxanthine plasma and urine levels(24 h)

Study Sites (1)

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