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Completed

NCT Number: NCT04028128

High Flavonols Cocoa Intake for the Improvement of Body Fat Composition in Athletes

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.

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Key information

Conditions

Healthy Subjects

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Jose Ángel García Merino

Villaviciosa de Odón, Madrid, 28670, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Men.
  • Age between 18 and 50 years
  • Aerobic power of oxygen consumption greater than or equal to 55 mL / kg / min

Exclusion criteria

  • Intake of chronical medication.
  • Intake any type of nutritional or ergogenic supplements.
  • Vegetarian or vegan diet
  • Smoke.
  • Any diagnosed disease at the time of inclusion or during the study

Treatment and study plan

Cocoa group

Dietary Supplement

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.

Placebo Group

Dietary Supplement

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.

Primary outcomes

  1. Change of body fat mass at 10 weeks

    Time frame: Fat mass was analyzed at the beginning (baseline time = 0) and after 10 weeks of intervention

    Energy X-ray absorptiometry (DEXA).

Secondary outcomes

  1. Change of lean mass at 10 weeks

    Time frame: Lean mass was analyzed at the beginning (baseline time) and after 10 weeks of intervention

    Energy X-ray absorptiometry (DEXA).

  2. Change in Sport performance test at 10 weeks

    Time frame: Sport performance was analyzed at the beginning (baseline time) and after 10 weeks of intervention

    Assessment of maximal aerobic capacity by treadmill test

  3. Change in Sport performance test 2 at 10 weeks

    Time frame: Sport performance was analyzed at the beginning (baseline time and after 10 weeks of intervention

    Measurement of the time that the sportsmen spend running one kilometer at the maximum speed.

  4. Change from baseline of adipokines at 10 weeks

    Time frame: Myostatin and Follistatin were analyzed at the beginning and at the end of the 10-week intervention.

    Myostatin and Follistatin levels were measured in plasma

  5. Change from baseline of leptin

    Time frame: Leptin was analyzed at the beginning and at the end of the 10-week intervention.

    leptin levels were measured in plasma by ELISA

  6. Change in Dietary habits at 10 weeks

    Time frame: Diet was analyzed at the beginning (baseline dose) and after 10 weeks of intervention.

    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.

  7. Change in Dietary habits 2 at 10 weeks

    Time frame: Diet was analyzed at the beginning (baseline dose) and after 10 weeks of intervention.

    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.

Sponsors and collaborators

Lead sponsor

Universidad Europea de Madrid

Other

Collaborators

  • Ministerio de Economía y Competitividad, Spain

Registry information

Official study title

Effects of Chronic Intake of High in Flavonols Cocoa on Body Composition, Adipokines and Exercise Performance

Acronym: COCOFAT

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 22, 2019
Registry last updated
Sep 26, 2019

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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