Healthy SubjectsINDYCANCT03897114
Cocoa Intake for Health Promotion in Athletes
A study testing Cocoa group in people with Healthy Subjects, run by Universidad Europea de Madrid at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Cocoa group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2017to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Men.
- Age between 18 and 50 years
- Aerobic power of oxygen consumption greater than or equal to 55 mL / kg / min
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
The objective of this project is to investigate the benefits of daily consumption of cocoa in endurance athletes in:
- 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
- Healthy Subjects
- Being tested
- Cocoa group, Placebo group
- Keywords
- Nutritional Supplement, Cocoa, Prebiotic, Physical Exercise, Gut Microbiota
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cocoa groupDietary 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 groupDietary 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
| Study group | Role | What they receive |
|---|---|---|
| Cocoa group | Experimental | 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). Receives: Dietary Supplement: Cocoa group |
| Placebo group | Placebo comparator | Maltodextrin will be supplied as a placebo, which will be provided in sachets. Athletes will take 5g of product per day. Receives: Dietary Supplement: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of fat mass
Energy X-ray absorptiometry (DEXA ).
Measured: Fat mass will be analyzed at the beginning (baseline dose) and after 10 weeks of intervention
Secondary outcomes (9)
Measurement of lean mass
Energy X-ray absorptiometry (DEXA ).
Measured: Lean mass will be analyzed at the beginning (baseline dose) and after 10 weeks of intervention
Sport performance test.
Assessment of maximal aerobic capacity.
Measured: 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.
Measured: Sport performance will be analyzed at the beginning (baseline dose) and after 10 weeks of intervention
Change in eating habits.
Food Frequency Questionnaire.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Nitric oxide will be analyzed at the beginning and at the end of the 10-week intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start1 Sep 2017
- Primary completion20 Feb 2019
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind placebo controlled study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain
- Responsible party
- Principal investigator, Mar Larrosa, Universidad Europea de Madrid
- Investigators
- María del Mar Larrosa Pérez, PhD, Principal investigator, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03897114
- Sponsor's protocol ID
- AGL2016-77288-R
- Acronym
- INDYCA
- Status last verified
- Apr 2021
- First submitted
- 4 Mar 2019
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cocoa Intake for the Prevention of Gastrointestinal Problems in Athletes: Effects on Oxidative Stress, Inflammation, Microbiota and Sports Performance
- ClinicalTrials.gov ID
- NCT03897114
- Acronym / sponsor ID
- INDYCA / AGL2016-77288-R
- Conditions
- Healthy Subjects
- Keywords
- Nutritional Supplement, Cocoa, Prebiotic, Physical Exercise, Gut Microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 20 Feb 2019 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 1 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The objective of this project is to investigate the benefits of daily consumption of cocoa in endurance athletes in:
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double blind placebo controlled study
| Arm | Type | Receives |
|---|---|---|
| Cocoa group | Experimental | Dietary Supplement: Cocoa groupThe 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). |
| Placebo group | Placebo comparator | Dietary Supplement: Placebo groupMaltodextrin will be supplied as a placebo, which will be provided in sachets. Athletes will take 5g of product per day. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Men.
- Age between 18 and 50 years
- Aerobic power of oxygen consumption greater than or equal to 55 mL / kg / min
Key exclusion criteria (6 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cocoa groupAthletes 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. | Dietary supplement | Cocoa group |
| Placebo groupThe athletes perform the same training program and they take for 10 weeks 5 g maltodextrin mixed with low-fat milk for 10 weeks | Dietary supplement | Placebo group |
Primary outcome
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 ).
9 secondary outcomes
Measurement of lean mass
Time frame: Lean mass will be analyzed at the beginning (baseline dose) and after 10 weeks of intervention
Sport performance test.
Time frame: Sport performance will be analyzed at the beginning (baseline dose) and after 10 weeks of intervention
Sport performance test 2.
Time frame: Sport performance will be analyzed at the beginning (baseline dose) and after 10 weeks of intervention
Change in eating habits.
Time frame: Lifestyle will be analyzed at the beginning (baseline dose) and after 10 weeks of intervention.
Change in Gut Microbiota
Time frame: Gut microbiota will be analyzed at the beginning (basiline dose) and after 10 weeks of intervention.
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.
Indicators of gastrointestinal barrier.
Time frame: 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
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
María del Mar Larrosa Pérez, PhD principal investigator
Universidad Europea de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cocoa group in people with Healthy Subjects, run by Universidad Europea de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of fat mass (time frame: Fat mass will be analyzed at the beginning (baseline dose) and after 10 weeks of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2021.