Healthy AthletesNCT04444388
Effect of Cocoa Supplementation in Training Athletes Microbiota and Metabolome
A study testing cocoa in people with Healthy Athletes, run by Universidad Europea de Madrid at 1 site in Spain.
Trial summary
It has recently been suggested that cocoa may improve exercise performance and recovery. This study aim to evaluate the plasma and fecal metabolome after 10 weeks of cocoa supplementation during the training period in recreational athletes to detect possible metabolites involved in the observed benefits of cocoa in… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Athletes
- What is being tested?
- cocoa
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2020to 1 Oct 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-45 years of age
- high physical condition (VO2 ≥ 55 ml/kg/min)
- BMI 18-25 kg/m2
Who cannot join
- antibiotics intake during 3 months prior to the study,
- smoking
- nutritional complements
- ergogenic complements
- prebiotics
- probiotics
Show all 10Show fewer
- vegetarian or vegan diet
- chronic medication
- gastrointestinal surgery
- Any diagnosed disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Cocoa Supplementation in Training Athletes Microbiota and Metabolome: Effects on Acute and Adaptive Exercise
It has recently been suggested that cocoa may improve exercise performance and recovery. This study aim to evaluate the plasma and fecal metabolome after 10 weeks of cocoa supplementation during the training period in recreational athletes to detect possible metabolites involved in the observed benefits of cocoa in athletes
- Conditions
- Healthy Athletes
- Being tested
- cocoa, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cocoaDietary supplement
Sachets of 5 grams of cocoa daily supplementation
PlaceboDietary supplement
Sachets of 5 grams of maltodextrin daily supplementation
| Study group | Role | What they receive |
|---|---|---|
| Cocoa group | Experimental | 5 g/day of flavonoid-rich defatted cocoa for 10 weeks Receives: Dietary Supplement: cocoa |
| Placebo group | Placebo comparator | 5 g/day of maltodextrin for 10 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal microbiota
Abundance of bacterial taxa determined by 16SRNAr gene sequencing
Measured: Changes from baseline to 10 weeks of intervention
Fecal metabolome profile
Abundance of fecal metabolites, metabolic networks, and metabolic pathways determined by High Pressure Liquid Chromatography-Mass Spectrometry
Measured: Changes from baseline to 10 weeks of intervention
Plasma metabolome profile
Abundance of blood metabolites, metabolic networks, and metabolic pathways activity determined by High Pressure Liquid Chromatography-Mass Spectrometry
Measured: Changes from baseline to 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 posted23 Jun 2020
- Study start1 Jul 2020
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AthletesStudies 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
- 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
- Responsible party
- Principal investigator, Mar Larrosa, Universidad Europea de Madrid
- Investigators
- Mar Larrosa, PhD, Principal investigator, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04444388
- Sponsor's protocol ID
- UEM005
- Status last verified
- Nov 2020
- First submitted
- 18 Jun 2020
- Last updated
- 4 Nov 2020
- 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 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cocoa Supplementation in Training Athletes Microbiota and Metabolome: Effects on Acute and Adaptive Exercise
- ClinicalTrials.gov ID
- NCT04444388
- Acronym / sponsor ID
- UEM005
- Conditions
- Healthy Athletes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 23 Jun 2020 (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.
It has recently been suggested that cocoa may improve exercise performance and recovery. This study aim to evaluate the plasma and fecal metabolome after 10 weeks of cocoa supplementation during the training period in recreational athletes to detect possible metabolites involved in the observed benefits of cocoa in athletes
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cocoa group | Experimental | Dietary Supplement: cocoa5 g/day of flavonoid-rich defatted cocoa for 10 weeks |
| Placebo group | Placebo comparator | Dietary Supplement: Placebo5 g/day of maltodextrin for 10 weeks |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-45 years of age
- high physical condition (VO2 ≥ 55 ml/kg/min)
- BMI 18-25 kg/m2
Key exclusion criteria (10 listed)
- antibiotics intake during 3 months prior to the study,
- smoking
- nutritional complements
- ergogenic complements
- prebiotics
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 |
|---|---|---|
| cocoaSachets of 5 grams of cocoa daily supplementation | Dietary supplement | Cocoa group |
| PlaceboSachets of 5 grams of maltodextrin daily supplementation | Dietary supplement | Placebo group |
Primary outcome
Fecal microbiota
Time frame: Changes from baseline to 10 weeks of intervention
Abundance of bacterial taxa determined by 16SRNAr gene sequencing
Fecal metabolome profile
Time frame: Changes from baseline to 10 weeks of intervention
Abundance of fecal metabolites, metabolic networks, and metabolic pathways determined by High Pressure Liquid Chromatography-Mass Spectrometry
Plasma metabolome profile
Time frame: Changes from baseline to 10 weeks of intervention
Abundance of blood metabolites, metabolic networks, and metabolic pathways activity determined by High Pressure Liquid Chromatography-Mass Spectrometry
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 4 Nov 2020.
- 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.
Mar Larrosa, 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 in people with Healthy Athletes, 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 10 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 4 Nov 2020. 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?
Fecal microbiota (time frame: Changes from baseline to 10 weeks of intervention). The study lists 3 primary outcomes in all. 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 4 Nov 2020.