Precision nutrition approach based on lipid and microbiota profile to promote health and performance in football players

ISRCTN ISRCTN18358034
DOI https://doi.org/10.1186/ISRCTN18358034
Secondary identifying numbers TUE-RS-2022-01
Submission date
04/10/2024
Registration date
14/10/2024
Last edited
11/10/2024
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English Summary

Background and study aims
In high-performance athletes, high physical activity produces stress at the cardiac, muscular and metabolic levels in general. At the cellular level, the ruptures caused by exercise must be repaired quickly and this depends on diverse factors, which may vary between individuals, some of which are controllable. Different studies indicate that physical activity promotes an inflammatory state and increases oxidative stress. To reverse these situations, supplements such as antioxidants, vitamins and fatty acids are increasingly used in sports practice, based on the idea that they are natural substances and they are not harmful. However, there are different aspects to be taken into account when using this type of product. A high dose may be harmful to the body, or a general recommendation may not be suitable for a given person. Therefore, the intake of these supplements should be considered according to the specific needs of the individual athlete. The use of new precision nutrition tools is making it possible to advance the personalisation and individualisation of nutritional interventions.
The main aim of this study is to design a personalised nutritional intervention. To this end, the lipid profile of mature erythrocyte membrane (LPMEM), the taxonomy profile of the gut microbiota (bacteria) and the quantification of metabolites and other variables, such as performance, endurance, recovery, injuries and diet, will be characterised. To this end, a study was carried out to determine the LPMEM, lifestyle and dietary pattern in football players from the Real Sociedad team (men's first and second teams and women's first team).

Who can participate?
Female and male football players aged 18 to 45 years from the Real Sociedad team

What does the study involve?
The study duration was the football seasons 2022-2023 and 2023-2024. Blood and stool samples, nutritional information and physical activity data were collected three times at the beginning of the season, mid-season and end of the season.
The nutritional intervention had three phases:
Pre-season: during the pre-season, the parameters above were analysed to define the nutritional intervention for each player. The athletes started the intervention at this time.
Mid-season: after 4 months, the same parameters were measured again for a new cycle of intervention.
End of season: the parameters obtained in the pre-season and mid-season were determined again and the relevant conclusions were drawn.

What are the possible benefits and risks of participating?
There are no risks of participating. The possible benefits are to enhance sports performance, inflammation state and gut health.

Where is the study run from?
Fundación AZTI (Spain)

When is the study starting and how long is it expected to run for?
March 2022 to September 2024

Who is funding the study?
1. Fundación AZTI (Spain)
2. Real Sociedad football team (Spain)

Who is the main contact?
Dr Itziar Tueros, itueros@azti.es

Contact information

Dr Itziar Tueros
Public, Principal Investigator

Astondo Bidea, Edificio 609
Derio
48160
Spain

ORCiD logoORCID ID 0000-0002-7609-5435
Phone +34 (0)677 174 290
Email itueros@azti.es
Dr Javier Amezaga
Scientific

Astondo Bidea, Edificio 609
Derio
48160
Spain

ORCiD logoORCID ID 0000-0003-1829-111X
Phone +34 (0)667141249
Email jamezaga@azti.es
Miss Nerea Peña
Scientific

Astondo Bidea, Edificio 609
Derio
48160
Spain

ORCiD logoORCID ID 0000-0002-5411-659X
Phone +34 (0)667174325
Email npena@azti.es

Study information

Study designInterventional study
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Fitness/sport facility
Study typeOther, Quality of life
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleGut microbiota modulation is associated with personalised fatty acids supplementation in professional football players assayed across the competitive season
Study hypothesisThis project is based on the hypothesis that mature erythrocytes and the taxonomic profile of the gut microbiota provide key information about the metabolism of each individual and their relationship with nutritional intake and lifestyle. Therefore, characterisation through these techniques is very useful for tailoring optimal nutritional recommendations from a precision nutrition approach.
Ethics approval(s)

Approved 02/05/2022, Research Ethics Committee of the Gipuzkoa Healthcare Area (Begiristain Doktorea Pasealekua, San Sebastian, 20014, Spain; +34 (0)943007402; mjose.velazquezzubicoa@oakidetza.net), ref: TUE-RS-2022-01

ConditionLipid profile of mature erythrocyte membrane and the composition of the gut microbiota
InterventionIntevention study to determine the lipid profile of mature erythrocyte membrane, and the composition of the gut microbiota associated with nutrition, lifestyle and dietary pattern in football players and to carry out a nutritional intervention based on the results obtained.

The study was conducted with adult female and male football players (>18 years old) from the Real Sociedad team, playing in the first and second divisions of the Spanish league over two seasons (2022-2023 and 2023-2024). Recruitment was conducted by the medical services of the Real Sociedad in Zubieta, Spain. The inclusion criteria were players who signed the informed consent to participate.

Other parameters were also studied, such as nutritional habits, by a validated Food Frequency Questionnaire (FFQ) PREDIMED for the Spanish population and physical activity. Additionally, other biochemical parameters were measured (plasma lipid profile, liver functions, inflammation), along with performance, endurance, recovery and injury history. This information was collected by medical and technical staff.

The nutritional intervention had three phases:
Pre-season: during the pre-season, the parameters mentioned above were analysed to define the nutritional intervention for each player. The athletes started the intervention at this time.
Mid-season: after 4 months, the same parameters were measured again for a new cycle of intervention.
End of season: the parameters obtained in the pre-season and mid-season were determined again and the relevant conclusions were drawn.
Intervention typeSupplement
Primary outcome measureInflammatory and nutritional status of the football players is measured through the analysis of the fatty acids in the membrane of the mature red blood cells (targeting omega-3, omega-6 and MUFA and SFA) at three points (T1: beginning of the season, T2: mid-season and T3: at the end of the season) during the seasons 2022-2023 and 2023-2024.
Secondary outcome measuresThere are no secondary outcome measures
Overall study start date14/03/2022
Overall study end date27/09/2024

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
Upper age limit45 Years
SexBoth
Target number of participants100
Total final enrolment77
Participant inclusion criteriaPlayers who signed the informed consent to participate
Participant exclusion criteria1. Not playing due to health reasons
2. Not having signed the informed consent form
Recruitment start date01/07/2022
Recruitment end date30/07/2024

Locations

Countries of recruitment

  • Spain

Study participating centres

Real Sociedad Fútbol Club
Anoeta Pasalekua,1
Donostia-San Sebastián
20014
Spain
Fundación AZTI
Astondo Bidea, Edificio 609
Derio
48160
Spain

Sponsor information

Fundación Azti
Research organisation

Astondo Bidea
Edificio 609
Derio
48160
Spain

Phone +34 946 574 000
Email info@azti.es
Website https://www.azti.es/

Funders

Funder type

Research organisation

Fundación AZTI

No information available

Real Sociedad Fútbol Club

No information available

Results and Publications

Intention to publish date10/10/2024
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planPlanned publication in a peer-reviewed journal
IPD sharing planThe datasets generated during and/or analysed during the current study are not expected to be made available due to the challenges of anonymising qualitative data and the risk of identifying study participants

Editorial Notes

04/10/2024: Study's existence confirmed by the Research Ethics Committee of the Gipuzkoa Healthcare Area