ClinicalTrials.Veeva

Menu

Cocoa Flavanols and Exercise Capacity

H

Heinrich-Heine University, Duesseldorf

Status

Completed

Conditions

Exercise Capacity

Treatments

Other: Cocoa

Study type

Interventional

Funder types

Other

Identifiers

NCT01259739
Flavanols - Exercise

Details and patient eligibility

About

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)

Full 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.

Enrollment

13 patients

Sex

Male

Ages

20 to 36 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

13 participants in 2 patient groups

Flavanol rich cocoa
Experimental group
Description:
(596 mg), dissolved in water, twice daily intervention
Treatment:
Other: Cocoa
flavanol poor cocoa drink
Experimental group
Description:
( 13mg) dissolved in water, twice daily intervention
Treatment:
Other: Cocoa

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems