Cocoa Flavanols and Exercise Capacity
The Impact of Dietary Cocoa Flavanols on Cardio-pulmonary Exercise Capacity in Human.
1 other identifier
interventional
13
1 country
1
Brief Summary
The purpose of this study is to characterize the potential improvement of cocoa flavanols on exercise capacity in highly trained cyclist. A placebo-controlled double-blinded randomized control study will be performed in 13 highly trained cyclist (crossover design). Participants will perform a baseline exercise testing on an ergometer. They will receive either a flavanol-poor or flavanol rich cocoa drink twice daily for one week before a second and third exercise testing is performed. The order of drinks is randomized and balanced (high-flavanol--\>low-flavanol drink or low-flavanol drink--\>high-flavanol drink)
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 Nov 2010
Typical duration 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
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 13, 2010
CompletedFirst Posted
Study publicly available on registry
December 14, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedNovember 8, 2013
November 1, 2013
2.9 years
December 13, 2010
November 7, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cardiopulmonary exercise capacity (time to complete time trail, lactate anaerobic threshold, cardio-pulmonary exercise capacity
7 days
Secondary Outcomes (1)
Endothelial function
7 days
Study Arms (2)
Flavanol rich cocoa
EXPERIMENTAL(596 mg), dissolved in water, twice daily intervention
flavanol poor cocoa drink
EXPERIMENTAL( 13mg) dissolved in water, twice daily intervention
Interventions
Eligibility Criteria
You may qualify if:
- highly trained cyclists (VO2 peak \> 50 ml/kg bodyweight)
- refrain from cocoa ingestion during trial
- training continued throughout testing
- \> 20 years
- male
You may not qualify if:
- \> 36 years
- poor endothelial function
- acute infection
- any chronic heart or pulmonary disease
- arrhythmias
- acute or chronic renal failure
- smokers
- cardio-vascular risk factors : diabetes mellitus, hypertension, hyperlipidemia
- intake of nutrition supplements (l-arginine, creatinine)
- intake of WADA listed doping substances
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Heinrich-Heine-University
Düsseldorf, North Rhine-Westphalia, 40225, Germany
Related Publications (1)
Rassaf T, Totzeck M, Hendgen-Cotta UB, Shiva S, Heusch G, Kelm M. Circulating nitrite contributes to cardioprotection by remote ischemic preconditioning. Circ Res. 2014 May 9;114(10):1601-10. doi: 10.1161/CIRCRESAHA.114.303822. Epub 2014 Mar 18.
PMID: 24643960DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tienush Rassaf, MD, PhD
Heinrich Heine University Düsseldorf, NRW, Germany
- STUDY CHAIR
Malte Kelm, MD, PhD
Heinrich Heine University Düsseldorf, NRW, Germany
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Tienush Rassaf, MD, PhD
Study Record Dates
First Submitted
December 13, 2010
First Posted
December 14, 2010
Study Start
November 1, 2010
Primary Completion
October 1, 2013
Study Completion
November 1, 2013
Last Updated
November 8, 2013
Record last verified: 2013-11