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

Healthy Subjects Clinical Trial

— COCOFAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04028128
• Other study ID #: AGL2016-77288-R-2
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: April 1, 2019

Study information

• Verified date: September 2019
• Source: Universidad Europea de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 1, 2019
• Est. primary completion date: February 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

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 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.

Locations

Country	Name	City	State
Spain	Jose Ángel García Merino	Villaviciosa De Odón	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Europea de Madrid	Ministerio de Economía y Competitividad, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.