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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Dietary supplement: Cocoa group; Dietary supplement: Placebo group

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Villaviciosa De Odón, Madrid, Spain, 28670
      • Jose Ángel García Merino

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cocoa group; 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; 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 Comparator: Placebo group; Maltodextrin (5 g) was supplied as placebo in sachets identical to those provided for cocoa.	Dietary supplement: Placebo group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of body fat mass at 10 weeks	Energy X-ray absorptiometry (DEXA).	Fat mass was analyzed at the beginning (baseline time = 0) and after 10 weeks of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of lean mass at 10 weeks	Energy X-ray absorptiometry (DEXA).	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	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.	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	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	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.	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.	Diet was analyzed at the beginning (baseline dose) and after 10 weeks of intervention.

Collaborators and Investigators

• Sponsor: Universidad Europea de Madrid
• Collaborators: Ministerio de Economía y Competitividad, Spain

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): February 20, 2019
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: July 18, 2019
• First Submitted That Met QC Criteria: July 19, 2019
• First Posted (Actual): July 22, 2019

Study Record Updates

• Last Update Posted (Actual): September 26, 2019
• Last Update Submitted That Met QC Criteria: September 24, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Nutritional Supplement; High in flavanoids cocoa; Body Fat composition; Physical Exercise performance
• Other Study ID Numbers: AGL2016-77288-R-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No