Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
13 participants
INTERVENTIONAL
2010-11-30
2013-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Baseline Testing:
Participants will perform a baseline testing consisting of an ergometric test with a step-wise increase of workload until exhaustion to determine lactate anaerobic threshold and cardio-pulmonary exercise capacity. Vascular function is monitored by Doppler Ultrasound.
In a second test, participants will perform a time trial (goal: as fast as possible)
Flavanol intervention Participants will twice daily receive either a flavanol-poor cocoa drink (13mg/dl)or a flavanol-rich cocoa drink (596mg/dl) over a period of 7 days. Order is randomized and balanced. Subjects will crossover to the second arm after a washout period of 7 days.
Testing performed on baseline day is repeated after the intake of both drinks
In a subgroup of n=6 participants, we will test whether the blood pressure cuff maneuver used for FMD will itself modify nitrite levels. For this the manuever will be completed 4 times and compared to n=6 untreated controls. in another subgroup 6 participants will receive 4times the maneuver but reperfusion will be limited by means of an ultrasound probe.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Flavanol rich cocoa
(596 mg), dissolved in water, twice daily intervention
Cocoa
dissolved in water twice-daily intervention
flavanol poor cocoa drink
( 13mg) dissolved in water, twice daily intervention
Cocoa
dissolved in water twice-daily intervention
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cocoa
dissolved in water twice-daily intervention
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* refrain from cocoa ingestion during trial
* training continued throughout testing
* \> 20 years
* male
Exclusion Criteria
* 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
20 Years
36 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Heinrich-Heine University, Duesseldorf
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Klinik für Kardiologie, Pneumologie und Angiologie
Tienush Rassaf, MD, PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Tienush Rassaf, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Heinrich Heine University Düsseldorf, NRW, Germany
Malte Kelm, MD, PhD
Role: STUDY_CHAIR
Heinrich Heine University Düsseldorf, NRW, Germany
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Heinrich-Heine-University
Düsseldorf, North Rhine-Westphalia, Germany
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Flavanols - Exercise
Identifier Type: -
Identifier Source: org_study_id