Exercise CapacityNCT01259739
Cocoa Flavanols and Exercise Capacity
A study testing Cocoa in people with Exercise Capacity, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 36 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise Capacity
- What is being tested?
- Cocoa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2010to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 36 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- highly trained cyclists (VO2 peak > 50 ml/kg bodyweight)
- refrain from cocoa ingestion during trial
- training continued throughout testing
- > 20 years
- male
Who cannot join
- > 36 years
- poor endothelial function
- acute infection
- any chronic heart or pulmonary disease
- arrhythmias
- acute or chronic renal failure
Show all 10Show fewer
- smokers
- cardio-vascular risk factors : diabetes mellitus, hypertension, hyperlipidemia
- intake of nutrition supplements (l-arginine, creatinine)
- intake of WADA listed doping substances
Trial locations and contacts
1 site in 1 country.
Germany1 site
Heinrich-Heine-University
Düsseldorf, North Rhine-Westphalia, 40225
About this study
Official title: The Impact of Dietary Cocoa Flavanols on Cardio-pulmonary Exercise Capacity in Human.
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)
Read the detailed description
13 participants (highly-trained cyclist, accustomed to exercise testing on ergometers will be enrolled (VO2max>50 ml/kg, FMD >5%, non-smokers, no medication, no diseases, age 20-36, male).
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
- Exercise Capacity
- Being tested
- Cocoa
- Keywords
- trained cyclists, no medications, no diseases, non-smokers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CocoaOther
dissolved in water twice-daily intervention
| Study group | Role | What they receive |
|---|---|---|
| Flavanol rich cocoa | Experimental | (596 mg), dissolved in water, twice daily intervention Receives: Other: Cocoa |
| flavanol poor cocoa drink | Experimental | ( 13mg) dissolved in water, twice daily intervention Receives: Other: Cocoa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiopulmonary exercise capacity (time to complete time trail, lactate anaerobic threshold, cardio-pulmonary exercise capacity
Measured: 7 days
Secondary outcomes (1)
Endothelial function
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionOct 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Exercise CapacityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
- Investigators
- Tienush Rassaf, MD, PhD, Principal investigator, Heinrich Heine University Düsseldorf, NRW, GermanyMalte Kelm, MD, PhD, Study chair, Heinrich Heine University Düsseldorf, NRW, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01259739
- Sponsor's protocol ID
- Flavanols - Exercise
- Status last verified
- Nov 2013
- First submitted
- 13 Dec 2010
- Last updated
- 8 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24643960
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Dietary Cocoa Flavanols on Cardio-pulmonary Exercise Capacity in Human.
- ClinicalTrials.gov ID
- NCT01259739
- Acronym / sponsor ID
- Flavanols - Exercise
- Conditions
- Exercise Capacity
- Keywords
- trained cyclists, no medications, no diseases, non-smokers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 14 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
13 participants (highly-trained cyclist, accustomed to exercise testing on ergometers will be enrolled (VO2max>50 ml/kg, FMD >5%, non-smokers, no medication, no diseases, age 20-36, male).
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flavanol rich cocoa | Experimental | Other: Cocoa(596 mg), dissolved in water, twice daily intervention |
| flavanol poor cocoa drink | Experimental | Other: Cocoa( 13mg) dissolved in water, twice daily intervention |
Who may qualify
- Ages
- 20 to 36 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- highly trained cyclists (VO2 peak > 50 ml/kg bodyweight)
- refrain from cocoa ingestion during trial
- training continued throughout testing
- > 20 years
- male
Key exclusion criteria (10 listed)
- > 36 years
- poor endothelial function
- acute infection
- any chronic heart or pulmonary disease
- arrhythmias
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cocoadissolved in water twice-daily intervention | Other | Flavanol rich cocoa, flavanol poor cocoa drink |
Primary outcome
Cardiopulmonary exercise capacity (time to complete time trail, lactate anaerobic threshold, cardio-pulmonary exercise capacity
Time frame: 7 days
1 secondary outcome
Endothelial function
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2013.
- Derived from this study: PubMed 24643960Rassaf 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 InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tienush Rassaf, MD, PhD principal investigator
Heinrich Heine University Düsseldorf, NRW, Germany
Malte Kelm, MD, PhD study chair
Heinrich Heine University Düsseldorf, NRW, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cocoa in people with Exercise Capacity, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiopulmonary exercise capacity (time to complete time trail, lactate anaerobic threshold, cardio-pulmonary exercise capacity (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01259739, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2013.