- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06073327
Short-term Cocoa Supplementation and Elite Soccer Players (COCOA)
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:
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Padova, Italy, 35131
- University of Padova
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• Elite football players playing in Serie A teams
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dark Chocolate
Dark chocolate group was provided with 30g of dark chocolate (high in flavanol) for 30 days
|
30g of dark or white chocolate was provided by the nutritionist for 30 days
|
Sham Comparator: White Chocolate
White chocolate group was provided with30g of white chocolate (0 mg/g of polyphenol) for 30 days
|
30g of white chocolate was provided by the nutritionist for 30 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1 month
|
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
|
1 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Antonio Paoli, MD, University of Padova
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Padova_Soccer
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dyslipidemias
-
IlDong Pharmaceutical Co LtdCompletedMixed DyslipidemiasKorea, Republic of
-
Orient Pharma Co., Ltd.CompletedPrimary Hypercholesterolemia | Mixed DyslipidemiasTaiwan, Australia, New Zealand
-
University of PaviaFoundation IRCCS San Matteo HospitalRecruiting
-
Çankırı Karatekin UniversityHacettepe UniversityRecruiting
-
Daewoong Pharmaceutical Co. LTD.RecruitingDyslipidemiasKorea, Republic of
-
AstraZenecaParexelRecruitingDyslipidemiaUnited States, United Kingdom
-
Jiangxi University of Traditional Chinese MedicineNot yet recruiting
-
Mackay Memorial HospitalAmgenRecruiting
-
EMSRecruiting
-
Daiichi SankyoDaiichi Sankyo Korea Co., Ltd.Active, not recruiting
Clinical Trials on dark chocolate
-
Loma Linda UniversityCompleted
-
Queen Margaret UniversityBarry CallebautCompletedBody WeightUnited Kingdom
-
Universidad de AntioquiaTerminated
-
University of Roma La SapienzaCompleted
-
Gregoire Wuerzner; MDRecruiting
-
University of the Incarnate WordCompleted
-
University of LeipzigCompleted
-
Eastern Mediterranean UniversityCompletedCardiovascular DiseasesTurkey