Influence of Age on the Absorption and Metabolism of Cocoa Flavanols

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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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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