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

October 3, 2023 updated by: University of Padova

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

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

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Padova, Italy, 35131
        • University of Padova

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Antonio Paoli, MD, University of Padova

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2023

Primary Completion (Actual)

May 3, 2023

Study Completion (Actual)

May 3, 2023

Study Registration Dates

First Submitted

June 1, 2023

First Submitted That Met QC Criteria

October 3, 2023

First Posted (Estimated)

October 9, 2023

Study Record Updates

Last Update Posted (Estimated)

October 9, 2023

Last Update Submitted That Met QC Criteria

October 3, 2023

Last Verified

May 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • Padova_Soccer

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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

Clinical Trials on dark chocolate

3
Subscribe