Cocoa Intake for Health Promotion in Athletes (INDYCA)

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Dietary supplement: Cocoa group; Dietary supplement: Placebo group

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Villaviciosa De Odón, Madrid, Spain, 28670
      • Jose Ángel García Merino

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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).	Dietary supplement: 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.
PLACEBO_COMPARATOR: Placebo group; Maltodextrin will be supplied as a placebo, which will be provided in sachets. Athletes will take 5g of product per day.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of fat mass	Energy X-ray absorptiometry (DEXA ).	Fat mass will be analyzed at the beginning (baseline dose) and after 10 weeks of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of lean mass	Energy X-ray absorptiometry (DEXA ).	Lean mass will be analyzed at the beginning (baseline dose) and after 10 weeks of intervention
Sport performance test.	Assessment of maximal aerobic capacity.	Sport performance will be analyzed at the beginning (baseline dose) and after 10 weeks of intervention
Sport performance test 2.	Measurement of the time that the sportsmen spend running one kilometer at the maximum speed.	Sport performance will be analyzed at the beginning (baseline dose) and after 10 weeks of intervention
Change in eating habits.	Food Frequency Questionnaire.	Lifestyle will be analyzed at the beginning (baseline dose) and after 10 weeks of intervention.
Change in Gut Microbiota	Determination of Microbial diversity by 16S rRNA Sequencing.	Gut microbiota will be analyzed at the beginning (basiline dose) and after 10 weeks of intervention.
Measurement of the parameters of inflammation.	Cytokines will be measured in plasma (IL-6, IL-10, IL-1β).	Plasma cytokines will be analyzed at the beginning and at the end of the 10-week intervention.
Indicators of gastrointestinal barrier.	Determination of plasmatic lipopolysaccharide (LPS) levels as an indicator of bacterial translocation.	Plasmatic LPS will be analyzed at the beginning and at the end of the 10-week intervention.
Modification from baseline of gastrointestinal symptoms at 10 weeks	The evaluation of gastrointestinal symptoms will be carried out through following the questionnaire described by Pfeiffer et al. (2009).	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.
Change from baseline of oxidative stress parameters .	Nitric oxide levels will be measured in plasma and urine.	Nitric oxide will be analyzed at the beginning and at the end of the 10-week intervention.

Collaborators and Investigators

• Sponsor: Universidad Europea de Madrid
• Collaborators: Ministerio de Economía y Competitividad, Spain

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2017
• Primary Completion (ACTUAL): February 20, 2019
• Study Completion (ACTUAL): December 31, 2020

Study Registration Dates

• First Submitted: March 4, 2019
• First Submitted That Met QC Criteria: March 29, 2019
• First Posted (ACTUAL): April 1, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 27, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Prebiotic; Gut Microbiota; Cocoa; Nutritional Supplement; Physical Exercise
• Other Study ID Numbers: AGL2016-77288-R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No