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Completed

NCT Number: NCT01259739

Cocoa Flavanols and Exercise Capacity

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)

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Key information

Conditions

Age range

20 year–36 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Heinrich-Heine-University

Düsseldorf, North Rhine-Westphalia, 40225, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • highly trained cyclists (VO2 peak > 50 ml/kg bodyweight)
  • refrain from cocoa ingestion during trial
  • training continued throughout testing
  • > 20 years
  • male

Exclusion criteria

  • > 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

Treatment and study plan

Cocoa

Other

dissolved in water twice-daily intervention

Primary outcomes

  1. Cardiopulmonary exercise capacity (time to complete time trail, lactate anaerobic threshold, cardio-pulmonary exercise capacity

    Time frame: 7 days

Secondary outcomes

  1. Endothelial function

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Heinrich-Heine University, Duesseldorf

Other

Registry information

Official study title

The Impact of Dietary Cocoa Flavanols on Cardio-pulmonary Exercise Capacity in Human.

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Dec 14, 2010
Registry last updated
Nov 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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