Influence of Age on the Absorption and Metabolism of Cocoa Flavanols

NCT01790009 | Completed Phase 1

• 1 other identifier: FLAV-AGE01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

ADME; Flavanols; Age; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Plasma and urine flavanol metabolites

  24 hours

Secondary Outcomes (1)

• Paracetamol and methylxanthine plasma and urine levels

  24 h

Study Arms (3)

Flavanol Rich drink

ACTIVE COMPARATOR

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

Dietary Supplement: Flavanol rich drink

Flavanol rich drink

ACTIVE COMPARATOR

Flavanol Intervention drink 400 mg/75 Kg BW

Dietary Supplement: Flavanol rich drink

Acetaminophen

ACTIVE COMPARATOR

2 tabletsx500 mg

Drug: Acetaminophen

Interventions

Flavanol rich drink DIETARY_SUPPLEMENT

Also known as: Comparison of two different doses of a flavanol rich drink

Flavanol Rich drink; Flavanol rich drink

Acetaminophen DRUG

2x500 mg Acetaminophen

Also known as: Paracetamol

Acetaminophen

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Reading: lead

Study Sites (1)

Department of Food and Nutritional Sciences

Reading, Berkshire, RG6 6AP, United Kingdom

Location

MeSH Terms

Interventions

Acetaminophen

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Jeremy Spencer, PhD

  University of Reading

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 8, 2013
• First Posted: February 12, 2013
• Study Start: February 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: February 12, 2013

Record last verified: 2013-02

Locations

GB (1)