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Influence of Age on the Absorption and Metabolism of Cocoa Flavanols

Sponsor
University of Reading (Other)
Overall Status
Completed
CT.gov ID
NCT01790009
Collaborator
(none)
40
Enrollment
1
Location
3
Arms
3.9
Duration (Months)
10.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Influence of Age on the Absorption and Metabolism of Cocoa Flavanols
Study Start Date :
Feb 1, 2011
Actual Primary Completion Date :
Jun 1, 2011
Actual Study Completion Date :
Jun 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Flavanol Rich drink

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

Dietary Supplement: Flavanol rich drink
Other Names:
  • Comparison of two different doses of a flavanol rich drink

    		•
    Active Comparator: Flavanol rich drink

    Flavanol Intervention drink 400 mg/75 Kg BW

    Dietary Supplement: Flavanol rich drink
    Other Names:
  • Comparison of two different doses of a flavanol rich drink

    		•
    Active Comparator: Acetaminophen

    2 tabletsx500 mg

    Drug: Acetaminophen
    2x500 mg Acetaminophen
    Other Names:
  • Paracetamol

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Plasma and urine flavanol metabolites [24 hours]

    Secondary Outcome Measures

    1. Paracetamol and methylxanthine plasma and urine levels [24 h]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    Male
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Food and Nutritional Sciences Reading Berkshire United Kingdom RG6 6AP

    Sponsors and Collaborators

    • University of Reading

    Investigators

    • Study Director: Jeremy Spencer, PhD, University of Reading

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jeremy Paul Edward Spencer, Professor, University of Reading
    ClinicalTrials.gov Identifier:
    NCT01790009
    Other Study ID Numbers:
    • FLAV-AGE01
    First Posted:
    Feb 12, 2013
    Last Update Posted:
    Feb 12, 2013
    Last Verified:
    Feb 1, 2013
    Keywords provided by Jeremy Paul Edward Spencer, Professor, University of Reading
    ADME
    Flavanols
    Age
    Pharmacokinetics
    Additional relevant MeSH terms:
    Acetaminophen

    Study Results

    No Results Posted as of Feb 12, 2013