AthletesPROMETHEONCT04301583
Procyanidin B2 Enriched Cocoa Effects on Mitochondrial Biogenesis
A study testing procyanidin B2 enriched cocoa in people with Athletes, run by Universidad Europea de Madrid at 1 site in Spain.
Trial summary
The purpose of this study is to test how cocoa-rich procyanidin B2 affect the mitochondrial exercise adaptations. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Athletes
- What is being tested?
- procyanidin B2 enriched cocoa
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2020to 1 Sep 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men/Women
- Age between 18 and 45 years
- Aerobic power of oxygen consumption greater than or equal to 55 mL / kg / min
Who cannot join
- Smoke
- Any chronic disease
- Intake of nutritional or ergogenic supplements
- Chronic medication
- Cocoa allergy
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to test how cocoa-rich procyanidin B2 affect the mitochondrial exercise adaptations.
- Conditions
- Athletes
- Being tested
- procyanidin B2 enriched cocoa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
procyanidin B2 enriched cocoaDietary supplement
Volunteers will intake 5 grams per day of dietary supplement for 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| Procyanidin B2 enriched cocoa | Active comparator | Participants receiving cocoa capsules Receives: Dietary Supplement: procyanidin B2 enriched cocoa |
| Placebo group | Placebo comparator | Participants maltodextrin capsules Receives: Dietary Supplement: procyanidin B2 enriched cocoa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in mitochondrial number
Number of mitochondria in blood cells measured by qPCR using mitochondrial COX1 gene and beta globin as housekeeping nuclear gene
Measured: 10 weeks
Difference in exercise performance
Maximum oxygen consumption
- of incomplete pulmonary gas exchange on VO2 max - Powers - Citado por 318
- determination of cardiorespiratory fitness and training … - Clark - Citado por 180 Maximum oxygen consumption
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start1 Jun 2020
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Participant, Investigator
- Enrolment
- 38 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, Principal investigator, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04301583
- Sponsor's protocol ID
- UEM004
- Acronym
- PROMETHEO
- Status last verified
- Nov 2020
- First submitted
- 5 Mar 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: There is not a plan to make IPD available
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
- Procyanidin B2 Enriched Cocoa Effects on Mitochondrial Biogenesis
- ClinicalTrials.gov ID
- NCT04301583
- Acronym / sponsor ID
- PROMETHEO / UEM004
- Conditions
- Athletes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 10 Mar 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.
The purpose of this study is to test how cocoa-rich procyanidin B2 affect the mitochondrial exercise adaptations.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Procyanidin B2 enriched cocoa | Active comparator | Dietary Supplement: procyanidin B2 enriched cocoaParticipants receiving cocoa capsules |
| Placebo group | Placebo comparator | Dietary Supplement: procyanidin B2 enriched cocoaParticipants maltodextrin capsules |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Men/Women
- Age between 18 and 45 years
- Aerobic power of oxygen consumption greater than or equal to 55 mL / kg / min
Key exclusion criteria (5 listed)
- Smoke
- Any chronic disease
- Intake of nutritional or ergogenic supplements
- Chronic medication
- Cocoa allergy
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 |
|---|---|---|
| procyanidin B2 enriched cocoaVolunteers will intake 5 grams per day of dietary supplement for 10 weeks | Dietary supplement | Placebo group, Procyanidin B2 enriched cocoa |
Primary outcome
Difference in mitochondrial number
Time frame: 10 weeks
Number of mitochondria in blood cells measured by qPCR using mitochondrial COX1 gene and beta globin as housekeeping nuclear gene
Difference in exercise performance
Time frame: 10 weeks
Maximum oxygen consumption * of incomplete pulmonary gas exchange on VO2 max - Powers - Citado por 318 * determination of cardiorespiratory fitness and training … - Clark - Citado por 180 Maximum oxygen consumption
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. There is not a plan to make IPD available
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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 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 procyanidin B2 enriched cocoa in people with 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 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 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?
Difference in mitochondrial number (time frame: 10 weeks). The study lists 2 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.