Cocoa Flavanols and Exercise Capacity

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)

Study Overview

• Status: Completed
• Conditions: Exercise Capacity
• Intervention / Treatment: Other: Cocoa

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 Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Duesseldorf, NRW, Germany, 40225
      • Heinrich-Heine-University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 36 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cardiopulmonary exercise capacity (time to complete time trail, lactate anaerobic threshold, cardio-pulmonary exercise capacity	7 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Endothelial function	7 days

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: December 13, 2010
• First Submitted That Met QC Criteria: December 13, 2010
• First Posted (Estimate): December 14, 2010

Study Record Updates

• Last Update Posted (Estimate): November 8, 2013
• Last Update Submitted That Met QC Criteria: November 7, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: trained cyclists; no medications; no diseases; non-smokers
• Other Study ID Numbers: Flavanols - Exercise

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No