NCT06073327

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 3, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2023

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 1, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
Last Updated

October 10, 2023

Status Verified

May 1, 2022

Enrollment Period

Same day

First QC Date

June 1, 2023

Last Update Submit

October 3, 2023

Conditions

Keywords

fatty acidsoccerdark chocolate

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Dark Chocolate

EXPERIMENTAL

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

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

Dietary Supplement: White chocolate

Interventions

dark chocolateDIETARY_SUPPLEMENT

30g of dark or white chocolate was provided by the nutritionist for 30 days

Dark Chocolate
White chocolateDIETARY_SUPPLEMENT

30g of white chocolate was provided by the nutritionist for 30 days

White Chocolate

Eligibility Criteria

Age18 Years - 38 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Elite football players playing in Serie A teams

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Padova

Padua, 35131, Italy

Location

MeSH Terms

Conditions

DyslipidemiasMetabolic Diseases

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersNutritional and Metabolic Diseases

Study Officials

  • Antonio Paoli, MD

    University of Padova

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2023

First Posted

October 10, 2023

Study Start

May 3, 2023

Primary Completion

May 3, 2023

Study Completion

May 3, 2023

Last Updated

October 10, 2023

Record last verified: 2022-05

Locations