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Completed

NCT Number: NCT03897114

Cocoa Intake for Health Promotion in Athletes

Athletes consume an extra of nutritional supplements every day with the purpose of improving their athletic performance, sometimes without being aware of their health. Cocoa could be a good nutritional supplement for athletes without causing them adverse effects. One of the most common health concerns in athletes are gastrointestinal problems. The cause of these problems seem to be a compendium of physiological and mechanical causes that are altered due to nutritional factors. Currently, there is no assay in which a nutritional intervention study has been proposed over time of training, in order to improve the gastrointestinal problems associated with the performance of physical exercise.

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Key information

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 is to investigate the benefits of daily consumption of cocoa in endurance athletes in:

A) Gastrointestinal problems associated with exercise. B) Reinforcement of the gastrointestinal barrier. C) Parameters of inflammation and oxidative stress. D) Sports performance. E) Body composition

The starting hypothesis of this project is based on the fact that daily cocoa consumption could improve the gastrointestinal symptoms associated with resistance exercise. Cocoa decreases the symptoms associated with splenic hypovolemia and strengthens the gastrointestinal epithelial barrier increasing the presence of Lactobacillus spp. and Bifidobacterium spp. in the intestinal microbiota.

A randomized, blinded, parallel placebo controlled intervention study will be carried out in endurance athletes who train in the sports facilities of the European University of Madrid. The number of male athletes for the study will be 56 (28 in each experimental group), all of them aimed at competition with an age between 18 and 40 years and an aerobic power consumption of oxygen greater than or equal to 55 mL / kg / min). The calculation of the sample size has been made selecting with a significance level alpha = 0.05 and a power (beta) of 0.90 for a 2-tailed analysis, taking into account we want to detect a difference of at least 15% in the improvement of the gastrointestinal symptoms, that the standard detected deviation in the questionnaire to be used, in previous studies, is 1.5 points out of 9 and that the expected proportion of losses is 15%.

Before and after the intervention, the athletes will do a test in which we will measure their maximum aerobic capacity. This will be done in the facilities of Europea University of Madrid where there is available a rolling belt. Also, they will do a second test in which we will measure the time they spend running a kilometer at the maximum speed. Body composition will be evaluated by dual-energy X-ray absorptiometry (DEXA). Blood, urine and feces samples will be required before and after the physical tests. Blood and urine samples will be collected in the morning while the feces samples will be collected the day before. The biological samples will be frozen at -80ºC until analyses.

The intervention will be carried out for 10 weeks. Cocoa or placebo will be provide in a single daily intake of 5 g of cocoa containing 500 mg of flavanols (dose at which a prebiotic effect has been demonstrated) or 5 g of maltodextrin.

Who can participate

Healthy volunteers accepted: No

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 antibiotics (3 months before the trial) or any chronical medication.
  • Intake of probiotics, prebiotics or any type of food or ergogenic supplements.
  • To be vegetarian or vegan
  • Smoke.
  • Have documented gastrointestinal diseases (ulcers, irritable bowel, ulcerative colitis, Crohn's disease, etc.).
  • Previous gastrointestinal surgeries or any disease diagnosed at the time of inclusion in the study

Treatment and study plan

Cocoa group

Dietary Supplement

Athletes perform the same training program and they take 5 g of cocoa (83 mg of flavonoids per gram of cocoa) mixed with low-fat milk for 10 weeks.

Placebo Group

Dietary Supplement

The athletes perform the same training program and they take for 10 weeks 5 g maltodextrin mixed with low-fat milk for 10 weeks

Primary outcomes

  1. Measurement of fat mass

    Time frame: Fat mass will be analyzed at the beginning (baseline dose) and after 10 weeks of intervention

    Energy X-ray absorptiometry (DEXA ).

Secondary outcomes

  1. Measurement of lean mass

    Time frame: Lean mass will be analyzed at the beginning (baseline dose) and after 10 weeks of intervention

    Energy X-ray absorptiometry (DEXA ).

  2. Sport performance test.

    Time frame: Sport performance will be analyzed at the beginning (baseline dose) and after 10 weeks of intervention

    Assessment of maximal aerobic capacity.

  3. Sport performance test 2.

    Time frame: Sport performance will be analyzed at the beginning (baseline dose) and after 10 weeks of intervention

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

  4. Change in eating habits.

    Time frame: Lifestyle will be analyzed at the beginning (baseline dose) and after 10 weeks of intervention.

    Food Frequency Questionnaire.

  5. Change in Gut Microbiota

    Time frame: Gut microbiota will be analyzed at the beginning (basiline dose) and after 10 weeks of intervention.

    Determination of Microbial diversity by 16S rRNA Sequencing.

  6. Measurement of the parameters of inflammation.

    Time frame: Plasma cytokines will be analyzed at the beginning and at the end of the 10-week intervention.

    Cytokines will be measured in plasma (IL-6, IL-10, IL-1β).

  7. Indicators of gastrointestinal barrier.

    Time frame: Plasmatic LPS will be analyzed at the beginning and at the end of the 10-week intervention.

    Determination of plasmatic lipopolysaccharide (LPS) levels as an indicator of bacterial translocation.

  8. Modification from baseline of gastrointestinal symptoms at 10 weeks

    Time frame: The questionnaire for the evaluation of gastrointestinal symptoms will be given to the athletes at the beginning and at the end of the 10-week intervention.

    The evaluation of gastrointestinal symptoms will be carried out through following the questionnaire described by Pfeiffer et al. (2009).

  9. Change from baseline of oxidative stress parameters .

    Time frame: Nitric oxide will be analyzed at the beginning and at the end of the 10-week intervention.

    Nitric oxide levels will be measured in plasma and urine.

Sponsors and collaborators

Lead sponsor

Universidad Europea de Madrid

Other

Collaborators

  • Ministerio de Economía y Competitividad, Spain

Registry information

Official study title

Cocoa Intake for the Prevention of Gastrointestinal Problems in Athletes: Effects on Oxidative Stress, Inflammation, Microbiota and Sports Performance

Acronym: INDYCA

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Apr 1, 2019
Registry last updated
Apr 27, 2021

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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