An interventional study of Cocoa group and Placebo group in Healthy Subjects, sponsored by Universidad Europea de Madrid. Completed at 1 site in Spain. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-26.
Sponsored by Universidad Europea de Madrid · Not applicable, Interventional, and Basic science
The decrease in body fat percentage improves exercise performance, reducing race time. The intake of cocoa improves the body fat composition in obese and diabetic people by improving their cardiovascular disease risk factors. Although epidemiological studies indicate that healthy subjects who consume cocoa have lower body fat composition, there is no study indicating whether cocoa improves fat composition in athletes. The aim of the study was to determine if the intake of cocoa rich in flavonoids improves the fat composition of athletes, modifying the systemic levels of adipokines (folistatin, myostatin and leptin), resulting in an improvement of physical performance.
The objective of this project was to investigate the effects of chronic daily consumption of high in flavanols cocoa in body composition and performance of endurance athletes:
A randomized, blinded, parallel placebo controlled intervention study was carried out in endurance athletes . The number of male athletes enrolled in the study was 40, with ages between 18 and 50 years and an aerobic power consumption of oxygen greater than or equal to 55 mL / kg / min). The intervention was carried out for 10 weeks. Cocoa or placebo (maltodextrin) were supplied in sachets of a single daily dose. Cocoa provided 425 mg of flavanols/ day.
Athlete's body composition was evaluated by dual-energy X-ray absorptiometry (DEXA). Exercise performance was evaluated with a treadmill test protocol determining the maximum aerobic capacity and also by determining the time necessary to run a kilometer at maximum speed.
Adipokines (follistatin, myostatin and leptin) in plasma and serum samples were determined by ELISA.
Diet was determined by three 24h-recall questionnaries and a Food Frecuency questionnaire.
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The cocoa was provided in 5 g sachets. The intervention last 10 weeks. Cocoa was provided in a single daily dose of 5 g, which provided 425 mg of flavonoids
Dietary Supplement: Cocoa group
Maltodextrin (5 g) was supplied as placebo in sachets identical to those provided for cocoa.
Dietary Supplement: Placebo group
Athletes performed a training program and consumed 5 g of cocoa (425 mg of flavonoids) mixed with semi-skimmed fat milk, daily for 10 weeks.
The athletes performed the same training program of the cocoa group and they took for 10 weeks 5 g of maltodextrin mixed with semi-skimmed fat milk.
Change of body fat mass at 10 weeks
Energy X-ray absorptiometry (DEXA).
Time frame: Fat mass was analyzed at the beginning (baseline time = 0) and after 10 weeks of intervention
Change of lean mass at 10 weeks
Energy X-ray absorptiometry (DEXA).
Time frame: Lean mass was analyzed at the beginning (baseline time) and after 10 weeks of intervention
Change in Sport performance test at 10 weeks
Assessment of maximal aerobic capacity by treadmill test
Time frame: Sport performance was analyzed at the beginning (baseline time) and after 10 weeks of intervention
Change in Sport performance test 2 at 10 weeks
Measurement of the time that the sportsmen spend running one kilometer at the maximum speed.
Time frame: Sport performance was analyzed at the beginning (baseline time and after 10 weeks of intervention
Change from baseline of adipokines at 10 weeks
Myostatin and Follistatin levels were measured in plasma
Time frame: Myostatin and Follistatin were analyzed at the beginning and at the end of the 10-week intervention.
Change from baseline of leptin
leptin levels were measured in plasma by ELISA
Time frame: Leptin was analyzed at the beginning and at the end of the 10-week intervention.
Change in Dietary habits at 10 weeks
Food Frequency Questionnaire. Consumption data were obtained for 93 foods. These data were entered into the DietSource software 3.0 (Novartis, Barcelona, Spain) to transform food data into percentage of carbohydrates, percentage of proteins and percentage of fat in the diet.
Time frame: Diet was analyzed at the beginning (baseline dose) and after 10 weeks of intervention.
Change in Dietary habits 2 at 10 weeks
24h recall questionnaire. This questionnaire was carried out 3 times on different days (2 weekdays and one weekend day) at the beginning (baseline) and after 10 weeks of intervention.These data were entered into the DietSource software 3.0 (Novartis, Barcelona, Spain) to transform food data into percentage of carbohydrates, percentage of proteins and percentage of fat in the diet.
Time frame: Diet was analyzed at the beginning (baseline dose) and after 10 weeks of intervention.
Plan to share: No
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Studies of the drug tested here: Cocoa bean
Universidad Europea de Madrid