The Effects of Alkalised Cocoa on Human Vascular Function
The Effect of Alkalisation on the Absorption, Metabolism and Vascular Reactivity of Cocoa Flavanols
1 other identifier
interventional
10
1 country
1
Brief Summary
The primary propose of this study is to determine how processing, in particular alkalisation, alters the vascular effects of high-flavanols foods such as cocoa
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2010
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 9, 2011
CompletedFirst Posted
Study publicly available on registry
March 10, 2011
CompletedMarch 10, 2011
November 1, 2010
3 months
March 9, 2011
March 9, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
In vivo circulatory effects relative to a non-alkalised high-flavanol cocoa.
Flow Mediated Dilation
change in Flow Mediated Dilation response between baseline and 2h
Study Arms (3)
Non alkalised High Flavanol
PLACEBO COMPARATORNon-alkalised high flavanol cocoa drink containing 1745 mg of total flavanols
Alkalised high Flavanol
ACTIVE COMPARATORAlkalised high flavanol cocoa drink (medium alkalisation) containing 410 mg of total flavanols
Alkalised Low Flavanol
ACTIVE COMPARATORAlkalised low flavanol cocoa drink (heavily alkalised) containing 1.26 mg of total flavanols
Interventions
Eligibility Criteria
You may qualify if:
- Male
- signed consent form
- age of 18-35 years inclusive
- BMI between 18.5-30
You may not qualify if:
- Blood pressure \> 150/90 mmHg
- Haemoglobin (anaemia marker) \< 125 g/l
- Gamma GT (liver enzymes) \> 80 IU/l
- Cholesterol \> 6.5 mmol/l
- Had suffered a myocardial infarction or stroke in the previous 12 months
- Suffers from any reproductive disorder
- Suffers from any blood-clotting disorder
- Suffers from any metabolic disorders (e.g. diabetes or any other endocrine or liver diseases)
- Any dietary restrictions or on a weight reducing diet
- Drinking more than 21 units per week
- On any lipid-modifying medication
- On any blood pressure lowering medication
- On any medication affecting blood clotting
- Planning on altering consumption of vitamin supplements/fish oil capsules during the course of the study
- Regular or vigorous exercise (3 times/week, 20 minutes each session)
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Reading
Reading, Berkshire, United Kingdom
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Jeremy Spencer, PhD
University of Reading
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 9, 2011
First Posted
March 10, 2011
Study Start
June 1, 2010
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
March 10, 2011
Record last verified: 2010-11