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

NCT04028128 | Completed

• 1 other identifier: AGL2016-77288-R-2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Keywords

Nutritional Supplement; High in flavanoids cocoa; Body Fat composition; Physical Exercise performance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change of lean mass at 10 weeks

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

• Change in Sport performance test at 10 weeks

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

• Change in Sport performance test 2 at 10 weeks

  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 were analyzed at the beginning and at the end of the 10-week intervention.

• Change from baseline of leptin

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

Study Arms (2)

Cocoa group

EXPERIMENTAL

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

Placebo group

PLACEBO COMPARATOR

Maltodextrin (5 g) was supplied as placebo in sachets identical to those provided for cocoa.

Dietary Supplement: Placebo group

Interventions

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.

Cocoa group

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.

Placebo group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: High performance sportsmen
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Intake of chronical medication.
• Intake any type of nutritional or ergogenic supplements.
• Vegetarian or vegan diet
• Smoke.

Sponsors & Collaborators

• Universidad Europea de Madrid: lead
• Ministerio de Economía y Competitividad, Spain: collaborator

Study Sites (1)

Jose Ángel García Merino

Villaviciosa de Odón, Madrid, 28670, Spain

Location

Study Officials

• María del Mar Larrosa Pérez, PhD

  Universidad Europea de Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Cocoa and maltodextrin (placebo) are provided in identical sachets which are identified with the letters A and B respectively.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tenure Professor

Model Details: Placebo controlled study

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: July 22, 2019
• Study Start: January 1, 2018
• Primary Completion: February 20, 2019
• Study Completion: April 1, 2019
• Last Updated: September 26, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)