Influence of Age on the Absorption and Metabolism of Cocoa Flavanols

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01790009

Enrollment

Registered

2013-02-12

Start date

2011-02-28

Completion date

2011-06-30

Last updated

2013-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

ADME, Flavanols, Age, Pharmacokinetics

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.

Interventions

DIETARY_SUPPLEMENTFlavanol rich drink

DRUGAcetaminophen

2x500 mg Acetaminophen

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to 80 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Plasma and urine flavanol metabolites	24 hours

Secondary

Measure	Time frame
Paracetamol and methylxanthine plasma and urine levels	24 h

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026