Clinical trial NCT04028128: High Flavonols Cocoa Intake for the Improvement of Body Fat Composition in Athletes
Official title: Effects of Chronic Intake of High in Flavonols Cocoa on Body Composition, Adipokines and Exercise Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Keywords: Nutritional Supplement
High in flavanoids cocoa
Body Fat composition
Physical Exercise performance
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
Collaborators: name: Ministerio de Economía y Competitividad, Spain
First posted: 2019-07-22
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Placebo controlled study
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of body fat mass at 10 weeks
timeFrame: Fat mass was analyzed at the beginning (baseline time = 0) and after 10 weeks of intervention
Secondary outcomes:
measure: Change of lean mass at 10 weeks
timeFrame: Lean mass was analyzed at the beginning (baseline time) and after 10 weeks of intervention
measure: Change in Sport performance test at 10 weeks
timeFrame: Sport performance was analyzed at the beginning (baseline time) and after 10 weeks of intervention
measure: Change in Sport performance test 2 at 10 weeks
timeFrame: Sport performance was analyzed at the beginning (baseline time and after 10 weeks of intervention
measure: Change from baseline of adipokines at 10 weeks
timeFrame: Myostatin and Follistatin were analyzed at the beginning and at the end of the 10-week intervention.
measure: Change from baseline of leptin
timeFrame: Leptin was analyzed at the beginning and at the end of the 10-week intervention.
measure: Change in Dietary habits at 10 weeks
timeFrame: Diet was analyzed at the beginning (baseline dose) and after 10 weeks of intervention.
measure: Change in Dietary habits 2 at 10 weeks
timeFrame: Diet was analyzed at the beginning (baseline dose) and after 10 weeks of intervention.
Other outcomes:
Locations:
city: Villaviciosa De Odón
country: Spain
facility: Jose Ángel García Merino
state: Madrid
Study officials:
affiliation: Universidad Europea de Madrid
name: María del Mar Larrosa Pérez, PhD
role: PRINCIPAL_INVESTIGATOR
References: