Influence of Age on the Absorption and Metabolism of Cocoa Flavanols

February 8, 2013 updated by: Jeremy Paul Edward Spencer, University of Reading
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Berkshire
      • Reading, Berkshire, United Kingdom, RG6 6AP
        • Department of Food and Nutritional Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma and urine flavanol metabolites
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Paracetamol and methylxanthine plasma and urine levels
Time Frame: 24 h
24 h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Reading

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

February 8, 2013

First Submitted That Met QC Criteria

February 8, 2013

First Posted (Estimate)

February 12, 2013

Study Record Updates

Last Update Posted (Estimate)

February 12, 2013

Last Update Submitted That Met QC Criteria

February 8, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FLAV-AGE01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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