Cocoa Intake for Health Promotion in Athletes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2020-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double blind placebo controlled study

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Cocoa and maltodextrin (placebo) are provided in identical sachets which are identified just with the letters A and B.

Study Groups

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Cocoa group

The cocoa will be provided in sachets. The intervention will be carried out for 10 weeks. Cocoa is provided in a single daily dose of 5 g, which contains 83 mg of flavonoids per gram of cocoa (dose at which a prebiotic effect has been shown).

Group Type EXPERIMENTAL

Cocoa group

Intervention Type 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

Maltodextrin will be supplied as a placebo, which will be provided in sachets. Athletes will take 5g of product per day.

Group Type PLACEBO_COMPARATOR

Placebo group

Intervention Type 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

Interventions

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Cocoa group

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.

Intervention Type DIETARY_SUPPLEMENT

Placebo group

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No