DyslipidemiasCOCOANCT06073327
Short-term Cocoa Supplementation and Elite Soccer Players
A study testing dark chocolate and White chocolate in people with Dyslipidemias and Fatty Acid; Metabolic Disorder, run by University of Padova at 1 site in Italy.
Trial summary
The goal of this interventional study was to investigate the impact of daily ingestion of 30g of dark chocolate on omega-3 fatty acid status and gut microbial community in professional soccer players. Read more about this study
- Who is it for?
- Ages 18 to 38 years, men only
- Conditions the study is for
- Dyslipidemias, Fatty Acid; Metabolic Disorder
- What is being tested?
- dark chocolate and White chocolate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteItaly
- Study dates
- 3 May 2023to 3 May 2023
- 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 38 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Elite football players playing in Serie A teams
Who cannot join
- Any disease or serious medical condition
- Probiotic use
- Special diet such as vegan or vegetarian or high-fiber
- Use of specific medications such as: non-steroidal anti-inflammatory drugs, antibiotics and statins taken in the last week
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short-term Cocoa Supplementation Influences Long-chain n-3 Polyunsaturated Fatty Acid Concentration and Microbiota Composition in Elite Male Football Players
The goal of this interventional study was to investigate the impact of daily ingestion of 30g of dark chocolate on omega-3 fatty acid status and gut microbial community in professional soccer players.
The main questions it aims to answer are:
Read more
Can 30g of dark chocolate positively influence the metabolism of polyunsaturated fatty acid (PUFAs) and, particularly, arachidonic acid (AA): eicosapentaenoic acid (EPA) ratio? Can 30g of dark chocolate change the microbial composition in professional soccer players? Elite male soccer players were randomly divided into 2 groups. One group was provided with 30g of dark chocolate 88% (2,5 mg/g of polyphenol) and one group, as control, was provided with with 30g of white chocolate (0 mg/g of polyphenol). Each group ingested the chocolate intervention as a "solid bar" in the morning (before 9:00 am) every day for 4 weeks. The dark chocolate and white chocolate were provided every morning to each subject by the nutritionist of each team, while, during off days, the chocolate was portioned into individual serving sizes and provided to each player. Adherence was checked by the nutritionist.
For each assessment, the participants arrived at the training center in the morning, after an overnight fast. Before the beginning and the end of the study, a 3-days food record (3dr) was recorded (2 weekdays and 1 week-end day) by the nutritionist. Blood was collected between 08:00 and 09:00 hours, fecal sample was delivered within the end of the morning, and anthropometry measures were determined.
Read the detailed description
This study was conducted in May 2022. Elite male soccer players (n=38) were randomly divided into two groups. The dark chocolate group (DC N=19) was provided with 30g of dark chocolate 88% (Novi Nero Nero 88% cacao, Elah Dufour S.p.A., Strada Serravalle 73, Novi Ligure) (2,5 mg/g of polyphenol). The white chocolate group (WC n=19) was provided with 30g of white chocolate. (Bianco Novi, Elah Dufour S.p.A., Strada Serravalle 73, Novi Ligure) (0 mg/g of polyphenol). Each group ingested the chocolate intervention as a "solid bar" in the morning (before 9:00 am) every day for 4 weeks. The participants were instructed to refrain from consuming chocolate or flavanol-containing products (i.e., blueberry, strawberry, blackberry, green tea, red wine, and pomegranate juice), starting from 3 days before the beginning of the study and throughout the intervention period. The dark chocolate and white chocolate were provided every morning to each subject by the nutritionist of each team, while, during off days, the chocolate was portioned into individual serving sizes and provided to each player. Adherence was checked by the nutritionist.
For each assessment, participants arrived at the training center in the morning, after an overnight fast. Before the beginning and the end of the study, a 3-days food record (3DR) was recorded (2 weekdays and 1 week-end day) by the nutritionist, blood was collected between 08:00 and 09:00 hours, fecal sample was delivered within the end of the morning, and anthropometry measures were determined. Briefly, for stool samples, athletes were asked to collect their fecal material (single defecation) in a plastic vial and place the vial in a labelled box. The nutritionist and/or the doctor of each team immediately collected the fresh stool samples and delivered them within 72h to the research hub facility (University of Padova, Department of Biomedical Science).
- Conditions
- Dyslipidemias, Fatty Acid; Metabolic Disorder
- Being tested
- dark chocolate, White chocolate
- Keywords
- fatty acid, soccer, dark chocolate
- Medical subject headings
- Dyslipidemias, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dark chocolateDietary supplement
30g of dark or white chocolate was provided by the nutritionist for 30 days
White chocolateDietary supplement
30g of white chocolate was provided by the nutritionist for 30 days
| Study group | Role | What they receive |
|---|---|---|
| Dark Chocolate | Experimental | Dark chocolate group was provided with 30g of dark chocolate (high in flavanol) for 30 days Receives: Dietary Supplement: dark chocolate |
| White Chocolate | Sham comparator | White chocolate group was provided with30g of white chocolate (0 mg/g of polyphenol) for 30 days Receives: Dietary Supplement: White chocolate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasmatic level of arachidonic acid and eicosapentaenoic acid (AA:EPA) ratio
Investigate the impact of daily ingestion of 30g of dark chocolate on omega-3 fatty acid status in professional soccer players
Measured: 1 month
Main compositional changes in gut microbiota
Investigate the impact of daily ingestion of 30g of dark chocolate gut microbial community in professional soccer players
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start3 May 2023
- Primary completion3 May 2023
- Study completion3 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiasStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio Paoli, MD, Principal investigator, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06073327
- Sponsor's protocol ID
- Padova_Soccer
- Acronym
- COCOA
- Status last verified
- May 2022
- First submitted
- 1 Jun 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Cocoa Supplementation Influences Long-chain n-3 Polyunsaturated Fatty Acid Concentration and Microbiota Composition in Elite Male Football Players
- ClinicalTrials.gov ID
- NCT06073327
- Acronym / sponsor ID
- COCOA / Padova_Soccer
- Conditions
- Dyslipidemias, Fatty Acid; Metabolic Disorder
- Keywords
- fatty acid, soccer, dark chocolate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 3 May 2023 (actual)
- Primary completion
- 3 May 2023 (actual)
- Study completion
- 3 May 2023 (actual)
- First posted
- 10 Oct 2023 (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 goal of this interventional study was to investigate the impact of daily ingestion of 30g of dark chocolate on omega-3 fatty acid status and gut microbial community in professional soccer players.
The main questions it aims to answer are:
Can 30g of dark chocolate positively influence the metabolism of polyunsaturated fatty acid (PUFAs) and, particularly, arachidonic acid (AA): eicosapentaenoic acid (EPA) ratio? Can 30g of dark chocolate change the microbial composition in professional soccer players? Elite male soccer players were randomly divided into 2 groups. One group was provided with 30g of dark chocolate 88% (2,5 mg/g of polyphenol) and one group, as control, was provided with with 30g of white chocolate (0 mg/g of polyphenol). Each group ingested the chocolate intervention as a "solid bar" in the morning (before 9:00 am) every day for 4 weeks. The dark chocolate and white chocolate were provided every morning to each subject by the nutritionist of each team, while, during off days, the chocolate was portioned into individual serving sizes and provided to each player. Adherence was checked by the nutritionist.
For each assessment, the participants arrived at the training center in the morning, after an overnight fast. Before the beginning and the end of the study, a 3-days food record (3dr) was recorded (2 weekdays and 1 week-end day) by the nutritionist. Blood was collected between 08:00 and 09:00 hours, fecal sample was delivered within the end of the morning, and anthropometry measures were determined.
Detailed description
This study was conducted in May 2022. Elite male soccer players (n=38) were randomly divided into two groups. The dark chocolate group (DC N=19) was provided with 30g of dark chocolate 88% (Novi Nero Nero 88% cacao, Elah Dufour S.p.A., Strada Serravalle 73, Novi Ligure) (2,5 mg/g of polyphenol). The white chocolate group (WC n=19) was provided with 30g of white chocolate. (Bianco Novi, Elah Dufour S.p.A., Strada Serravalle 73, Novi Ligure) (0 mg/g of polyphenol). Each group ingested the chocolate intervention as a "solid bar" in the morning (before 9:00 am) every day for 4 weeks. The participants were instructed to refrain from consuming chocolate or flavanol-containing products (i.e., blueberry, strawberry, blackberry, green tea, red wine, and pomegranate juice), starting from 3 days before the beginning of the study and throughout the intervention period. The dark chocolate and white chocolate were provided every morning to each subject by the nutritionist of each team, while, during off days, the chocolate was portioned into individual serving sizes and provided to each player. Adherence was checked by the nutritionist.
For each assessment, participants arrived at the training center in the morning, after an overnight fast. Before the beginning and the end of the study, a 3-days food record (3DR) was recorded (2 weekdays and 1 week-end day) by the nutritionist, blood was collected between 08:00 and 09:00 hours, fecal sample was delivered within the end of the morning, and anthropometry measures were determined. Briefly, for stool samples, athletes were asked to collect their fecal material (single defecation) in a plastic vial and place the vial in a labelled box. The nutritionist and/or the doctor of each team immediately collected the fresh stool samples and delivered them within 72h to the research hub facility (University of Padova, Department of Biomedical Science).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dark Chocolate | Experimental | Dietary Supplement: dark chocolateDark chocolate group was provided with 30g of dark chocolate (high in flavanol) for 30 days |
| White Chocolate | Sham comparator | Dietary Supplement: White chocolateWhite chocolate group was provided with30g of white chocolate (0 mg/g of polyphenol) for 30 days |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Elite football players playing in Serie A teams
Key exclusion criteria (4 listed)
- Any disease or serious medical condition
- Probiotic use
- Special diet such as vegan or vegetarian or high-fiber
- Use of specific medications such as: non-steroidal anti-inflammatory drugs, antibiotics and statins taken in the last week
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 |
|---|---|---|
| dark chocolate30g of dark or white chocolate was provided by the nutritionist for 30 days | Dietary supplement | Dark Chocolate |
| White chocolate30g of white chocolate was provided by the nutritionist for 30 days | Dietary supplement | White Chocolate |
Primary outcome
Plasmatic level of arachidonic acid and eicosapentaenoic acid (AA:EPA) ratio
Time frame: 1 month
Investigate the impact of daily ingestion of 30g of dark chocolate on omega-3 fatty acid status in professional soccer players
Main compositional changes in gut microbiota
Time frame: 1 month
Investigate the impact of daily ingestion of 30g of dark chocolate gut microbial community in professional soccer players
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 10 Oct 2023.
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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.
Antonio Paoli, MD principal investigator
University of Padova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dark chocolate and White chocolate in people with Dyslipidemias and Fatty Acid; Metabolic Disorder, run by University of Padova at 1 site in Italy.
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 1 inclusion and 4 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 10 Oct 2023. 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 Italy. 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?
Plasmatic level of arachidonic acid and eicosapentaenoic acid (AA:EPA) ratio (time frame: 1 month). 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 10 Oct 2023.