Healthy SubjectsCOCOFATNCT04028128
High Flavonols Cocoa Intake for the Improvement of Body Fat Composition 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
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- 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
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2018to 1 Apr 2019
- 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
- Healthy volunteers accepted
- 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 chronical medication.
- Intake any type of nutritional or ergogenic supplements.
- Vegetarian or vegan diet
- Smoke.
- Any diagnosed disease at the time of inclusion or during the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Chronic Intake of High in Flavonols Cocoa on Body Composition, Adipokines and Exercise Performance
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.
Read the detailed description
The objective of this project was to investigate the effects of chronic daily consumption of high in flavanols cocoa in body composition and performance of endurance athletes:
A randomized, blinded, parallel placebo controlled intervention study was carried out in endurance athletes . The number of male athletes enrolled in the study was 40, with ages between 18 and 50 years and an aerobic power consumption of oxygen greater than or equal to 55 mL / kg / min). The intervention was carried out for 10 weeks. Cocoa or placebo (maltodextrin) were supplied in sachets of a single daily dose. Cocoa provided 425 mg of flavanols/ day.
Athlete's body composition was evaluated by dual-energy X-ray absorptiometry (DEXA). Exercise performance was evaluated with a treadmill test protocol determining the maximum aerobic capacity and also by determining the time necessary to run a kilometer at maximum speed.
Adipokines (follistatin, myostatin and leptin) in plasma and serum samples were determined by ELISA.
Diet was determined by three 24h-recall questionnaries and a Food Frecuency questionnaire.
- Conditions
- Healthy Subjects
- Being tested
- Cocoa group, Placebo group
- Keywords
- Nutritional Supplement, High in flavanoids cocoa, Body Fat composition, Physical Exercise performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cocoa groupDietary 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.
Placebo groupDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Cocoa group |
| Placebo group | Placebo comparator | Maltodextrin (5 g) was supplied as placebo in sachets identical to those provided for cocoa. Receives: Dietary Supplement: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of body fat mass at 10 weeks
Energy X-ray absorptiometry (DEXA).
Measured: 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
Energy X-ray absorptiometry (DEXA).
Measured: Lean mass was analyzed at the beginning (baseline time) and after 10 weeks of intervention
Change in Sport performance test at 10 weeks
Assessment of maximal aerobic capacity by treadmill test
Measured: Sport performance was analyzed at the beginning (baseline time) and after 10 weeks of intervention
Change in Sport performance test 2 at 10 weeks
Measurement of the time that the sportsmen spend running one kilometer at the maximum speed.
Measured: 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 levels were measured in plasma
Measured: Myostatin and Follistatin were analyzed at the beginning and at the end of the 10-week intervention.
Change from baseline of leptin
leptin levels were measured in plasma by ELISA
Measured: Leptin was analyzed at the beginning and at the end of the 10-week intervention.
Change in Dietary habits at 10 weeks
Food Frequency Questionnaire. Consumption data were obtained for 93 foods. These data were entered into the DietSource software 3.0 (Novartis, Barcelona, Spain) to transform food data into percentage of carbohydrates, percentage of proteins and percentage of fat in the diet.
Measured: Diet was analyzed at the beginning (baseline dose) and after 10 weeks of intervention.
Change in Dietary habits 2 at 10 weeks
24h recall questionnaire. This questionnaire was carried out 3 times on different days (2 weekdays and one weekend day) at the beginning (baseline) and after 10 weeks of intervention.These data were entered into the DietSource software 3.0 (Novartis, Barcelona, Spain) to transform food data into percentage of carbohydrates, percentage of proteins and percentage of fat in the diet.
Measured: Diet was analyzed at the beginning (baseline dose) and after 10 weeks of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start1 Jan 2018
- Primary completion20 Feb 2019
- Study completion1 Apr 2019
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Placebo controlled study
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 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
- NCT04028128
- Sponsor's protocol ID
- AGL2016-77288-R-2
- Acronym
- COCOFAT
- Status last verified
- Sep 2019
- First submitted
- 18 Jul 2019
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Chronic Intake of High in Flavonols Cocoa on Body Composition, Adipokines and Exercise Performance
- ClinicalTrials.gov ID
- NCT04028128
- Acronym / sponsor ID
- COCOFAT / AGL2016-77288-R-2
- Conditions
- Healthy Subjects
- Keywords
- Nutritional Supplement, High in flavanoids cocoa, Body Fat composition, Physical Exercise performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 20 Feb 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 22 Jul 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.
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.
Detailed description
The objective of this project was to investigate the effects of chronic daily consumption of high in flavanols cocoa in body composition and performance of endurance athletes:
A randomized, blinded, parallel placebo controlled intervention study was carried out in endurance athletes . The number of male athletes enrolled in the study was 40, with ages between 18 and 50 years and an aerobic power consumption of oxygen greater than or equal to 55 mL / kg / min). The intervention was carried out for 10 weeks. Cocoa or placebo (maltodextrin) were supplied in sachets of a single daily dose. Cocoa provided 425 mg of flavanols/ day.
Athlete's body composition was evaluated by dual-energy X-ray absorptiometry (DEXA). Exercise performance was evaluated with a treadmill test protocol determining the maximum aerobic capacity and also by determining the time necessary to run a kilometer at maximum speed.
Adipokines (follistatin, myostatin and leptin) in plasma and serum samples were determined by ELISA.
Diet was determined by three 24h-recall questionnaries and a Food Frecuency questionnaire.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Placebo controlled study
| Arm | Type | Receives |
|---|---|---|
| Cocoa group | Experimental | Dietary Supplement: Cocoa groupThe 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 |
| Placebo group | Placebo comparator | Dietary Supplement: Placebo groupMaltodextrin (5 g) was supplied as placebo in sachets identical to those provided for cocoa. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- 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 (5 listed)
- Intake of chronical medication.
- Intake any type of nutritional or ergogenic supplements.
- Vegetarian or vegan diet
- Smoke.
- Any diagnosed disease at the time of inclusion or during the study
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 performed a training program and consumed 5 g of cocoa (425 mg of flavonoids) mixed with semi-skimmed fat milk, daily for 10 weeks. | Dietary supplement | Cocoa group |
| Placebo groupThe 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. | Dietary supplement | Placebo group |
Primary outcome
Change of body fat mass at 10 weeks
Time frame: Fat mass was analyzed at the beginning (baseline time = 0) and after 10 weeks of intervention
Energy X-ray absorptiometry (DEXA).
7 secondary outcomes
Change of lean mass at 10 weeks
Time frame: Lean mass was analyzed at the beginning (baseline time) and after 10 weeks of intervention
Change in Sport performance test at 10 weeks
Time frame: Sport performance was analyzed at the beginning (baseline time) and after 10 weeks of intervention
Change in Sport performance test 2 at 10 weeks
Time frame: Sport performance was analyzed at the beginning (baseline time and after 10 weeks of intervention
Change from baseline of adipokines at 10 weeks
Time frame: Myostatin and Follistatin were analyzed at the beginning and at the end of the 10-week intervention.
Change from baseline of leptin
Time frame: Leptin was analyzed at the beginning and at the end of the 10-week intervention.
Change in Dietary habits at 10 weeks
Time frame: Diet was analyzed at the beginning (baseline dose) and after 10 weeks of intervention.
Change in Dietary habits 2 at 10 weeks
Time frame: Diet was analyzed at the beginning (baseline dose) and after 10 weeks of 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 26 Sep 2019.
- Individual participant dataSharing planned: No
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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 5 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 26 Sep 2019. 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?
Change of body fat mass at 10 weeks (time frame: Fat mass was analyzed at the beginning (baseline time = 0) 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 26 Sep 2019.