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Cocoa Flavanols and Exercise Capacity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:
NCT01259739
First received: December 13, 2010
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

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)


Condition Intervention
Exercise Capacity
Other: Cocoa

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Impact of Dietary Cocoa Flavanols on Cardio-pulmonary Exercise Capacity in Human.

Resource links provided by NLM:


Further study details as provided by Heinrich-Heine University, Duesseldorf:

Primary Outcome Measures:
  • Cardiopulmonary exercise capacity (time to complete time trail, lactate anaerobic threshold, cardio-pulmonary exercise capacity [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Endothelial function [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: November 2010
Study Completion Date: November 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Flavanol rich cocoa
(596 mg), dissolved in water, twice daily intervention
Other: Cocoa
dissolved in water twice-daily intervention
Experimental: flavanol poor cocoa drink
( 13mg) dissolved in water, twice daily intervention
Other: Cocoa
dissolved in water twice-daily intervention

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.

  Eligibility

Ages Eligible for Study:   20 Years to 36 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01259739

Locations
Germany
Heinrich-Heine-University
Duesseldorf, NRW, Germany, 40225
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
Investigators
Principal Investigator: Tienush Rassaf, MD, PhD Heinrich Heine University Düsseldorf, NRW, Germany
Study Chair: Malte Kelm, MD, PhD Heinrich Heine University Düsseldorf, NRW, Germany
  More Information

Additional Information:
No publications provided by Heinrich-Heine University, Duesseldorf

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Klinik für Kardiologie, Pneumologie und Angiologie, Tienush Rassaf, MD, PhD, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT01259739     History of Changes
Other Study ID Numbers: Flavanols - Exercise
Study First Received: December 13, 2010
Last Updated: November 7, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Heinrich-Heine University, Duesseldorf:
trained cyclists
no medications
no diseases
non-smokers

ClinicalTrials.gov processed this record on November 24, 2014