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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06073327
Other study ID # Padova_Soccer
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 3, 2023
Est. completion date May 3, 2023

Study information

Verified date May 2022
Source University of Padova
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date May 3, 2023
Est. primary completion date May 3, 2023
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 38 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
dark chocolate
30g of dark or white chocolate was provided by the nutritionist for 30 days
White chocolate
30g of white chocolate was provided by the nutritionist for 30 days

Locations

Country Name City State
Italy University of Padova Padova

Sponsors (1)

Lead Sponsor Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 1 month
Primary Main compositional changes in gut microbiota Investigate the impact of daily ingestion of 30g of dark chocolate gut microbial community in professional soccer players 1 month
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