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Short-term Cocoa Supplementation and Elite Soccer Players (COCOA)

Primary Purpose

Dyslipidemias, Fatty Acid; Metabolic Disorder

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
dark chocolate
White chocolate
Sponsored by
University of Padova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemias focused on measuring fatty acid, soccer, dark chocolate

Eligibility Criteria

18 Years - 38 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Padova

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Dark Chocolate

White Chocolate

Arm Description

Dark chocolate group was provided with 30g of dark chocolate (high in flavanol) for 30 days

White chocolate group was provided with30g of white chocolate (0 mg/g of polyphenol) for 30 days

Outcomes

Primary Outcome Measures

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
Main compositional changes in gut microbiota
Investigate the impact of daily ingestion of 30g of dark chocolate gut microbial community in professional soccer players

Secondary Outcome Measures

Full Information

First Posted
June 1, 2023
Last Updated
October 3, 2023
Sponsor
University of Padova
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1. Study Identification

Unique Protocol Identification Number
NCT06073327
Brief Title
Short-term Cocoa Supplementation and Elite Soccer Players
Acronym
COCOA
Official Title
Short-term Cocoa Supplementation Influences Long-chain n-3 Polyunsaturated Fatty Acid Concentration and Microbiota Composition in Elite Male Football Players
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
May 3, 2023 (Actual)
Primary Completion Date
May 3, 2023 (Actual)
Study Completion Date
May 3, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Padova

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemias, Fatty Acid; Metabolic Disorder
Keywords
fatty acid, soccer, dark chocolate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dark Chocolate
Arm Type
Experimental
Arm Description
Dark chocolate group was provided with 30g of dark chocolate (high in flavanol) for 30 days
Arm Title
White Chocolate
Arm Type
Sham Comparator
Arm Description
White chocolate group was provided with30g of white chocolate (0 mg/g of polyphenol) for 30 days
Intervention Type
Dietary Supplement
Intervention Name(s)
dark chocolate
Intervention Description
30g of dark or white chocolate was provided by the nutritionist for 30 days
Intervention Type
Dietary Supplement
Intervention Name(s)
White chocolate
Intervention Description
30g of white chocolate was provided by the nutritionist for 30 days
Primary Outcome Measure Information:
Title
Plasmatic level of arachidonic acid and eicosapentaenoic acid (AA:EPA) ratio
Description
Investigate the impact of daily ingestion of 30g of dark chocolate on omega-3 fatty acid status in professional soccer players
Time Frame
1 month
Title
Main compositional changes in gut microbiota
Description
Investigate the impact of daily ingestion of 30g of dark chocolate gut microbial community in professional soccer players
Time Frame
1 month

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Paoli, MD
Organizational Affiliation
University of Padova
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Padova
City
Padova
ZIP/Postal Code
35131
Country
Italy

12. IPD Sharing Statement

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Short-term Cocoa Supplementation and Elite Soccer Players

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