A precision nutrition approach based on lipid and microbiota profiles in football players
| ISRCTN | ISRCTN53597010 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53597010 |
| Secondary identifying numbers | AME-RS-2024-02 |
- Submission date
- 20/11/2024
- Registration date
- 21/11/2024
- Last edited
- 21/11/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Backgroud 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. In this sense, omics technologies such as erythrocyte membrane lipidomics, genomics of the microbiota composition, and the study of microbiota metabolites are very appropriate to assess the nutritional status of the athlete, and thus offer personalised nutritional and supplementation recommendations for each player.
The main objective of this project is to characterise the membrane lipid profile, the genomics of the gut microbiota and the metabolites associated with nutrition and the microbiota of the football players of Real Sociedad team in order to establish the relationship between nutritional and metabolic status and, at the same time, to carry out a personalised nutritional and supplementation intervention based on this. In addition, as this is a prospective study, the effect of the course of the seasons and the practice of football over time on these parameters will be analysed. A secondary objective is also to study the relationship between the lipidomic and microbiomic profile with other variables such as performance, endurance, recovery, injuries and diet.
Who can participate?
Female and male players which are playing in the Real Sociedad teams, that signed the informed consent to participate.
What does the study involve?
The study duration is three competitive football seasons 2024-2025, 2025-2026 and 2026-2027.
Data collection (blood samples for biochemical parameters and LPMEM, stool samples for taxonomic profile of GM and SCFA profile on faeces, nutritional information through FFQ, performance, endurance, recovery and injury history accessible from medical staff and gut health and fatigue data using a wellness and Digestion-associated Quality of Life Questionnaire surveys) at two times during the season, beginning of the season and mid-season.
There was a personalised intervention of fatty acids supplements based on the lipid profile and gut symptoms.
What are the possible benefits and risks of participating?
There are not any risks of participating. The possible benefits are to enhance sport performance, inflammation state and gut health symptoms.
Where is the study run from?
Blood samples were collected at Policlinica Hospital (San Sebastian, Spain), stool samples and rest of the data were collected in spot facilities (Zubieta, San Sebastian, Spain). Data curation and supplementation recommendation was done in AZTI (Derio, Spain).
When is the study starting and how long is it expected to run for?
The study started at late September of 2024 and it is expected to finish at late 2027.
Who is funding the study?
The project is funded by Pileje Laboratories (Spain)
Who is the main contact?
Dr Itziar Tueros, itueros@azti.es
Dr Javier Amézaga, jamezaga@azti.es
Contact information
Public, Principal Investigator
Astondo Bidea, Edificio 609
Derio
48160
Spain
 ORCID ID |
0000-0002-7609-5435 |
|---|---|
| Phone | +34 677 174 290 |
| itueros@azti.es |
Public, Scientific, Principal Investigator
Astondo Bidea, Edificio 609
Derio
48160
Spain
| ORCID ID |
0000-0003-1829-111X |
|---|---|
| Phone | +34 667141249 |
| jamezaga@azti.es |
Scientific
Astondo Bidea, Edificio 609
Derio
48160
Spain
| ORCID ID |
0000-0002-5411-659X |
|---|---|
| Phone | +34 667174325 |
| npena@azti.es |
Study information
| Study design | Interventional non randomized study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Fitness/sport facility, Workplace |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Personalised intervention with fatty acid and probiotics supplements in football players across three competitive seasons |
| Study objectives | This project is based on the hypothesis that mature erythrocytes, the taxonomic profile of the gut microbiota (GM), and short-chain fatty acids (SCFA) in faeces provide key information about the metabolism of each individual and their relationship with nutritional intake and habits. Therefore, characterisation through these techniques is very useful for defining optimal nutritional recommendations from a precision nutrition approach. |
| Ethics approval(s) |
Approved 15/10/2024, Research Ethics Committee of the Gipuzkoa Healthcare Area (Begiristain Doktorea Pasealekua, Donostia-San Sebastián, 20014, Spain; +34 943 00 74 02; osid.cei@osakidetza.eus), ref: AME-RS-2024-02 |
| Health condition(s) or problem(s) studied | To determine the lipid profile of mature erythrocyte membrane (LPMEM), the composition of the GM and the profile of (SCFA) |
| Intervention | Pilot intervention study to determine the LPMEM , the composition of the GM, the metabolites associated with nutrition, lifestyle and dietary pattern in football players to carry out a nutritional intervention based on the results obtained. In total 100 football players, 80 adult female and male football players (>18 years old) from the Real Sociedad team, playing in the first and second division of the Spanish league, and 20 players from the youth team (<18 years old) who will foreseeably have continuity in the team and will reach the first categories, are participating. Recruitment is carried out by the medical services of the Real Sociedad in Zubieta, Spain. The inclusion criteria are be a player and be active in the Real Sociedad football team and players that signed the informed consent to participate. The study is conducted over 3 seasons (2024 - 2025, 2025 - 2026 and 2026 - 2027). Those players who leave the club, will no longer participate in the study. In the same way, it is envisaged that people who join in the future will become part of the study. On the other hand, other parameters were also studied, such as, nutritional habits, modifying a validated Food Frequency Questionnaire (FFQ) PREDIMED for the Spanish population, quality diet, physical activity data, and gut health and fatigue data using a wellness and Digestion-associated Quality of Life Questionnaire surveys. 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. Nutritional intervention phases: Beginning of the season (September): the parameters mentioned above are analysed to define the nutritional intervention for each player. The athletes started the intervention at this time. Mid-season (January): after 4 months, the same parameters were measured again for a new cycle of intervention. Each year the intervention process will be repeated as described in the previous two points. |
| Intervention type | Supplement |
| Primary outcome measure | LPMEM data, taxonomic and SCFA profiles are collected at two points during the seasons. The personalised supplementation was based on the LPMEM and reported gut symptoms. |
| Secondary outcome measures | Effects of the supplementation along with other variables on the taxonomic profile of GM and SCFA profile in faeces collected at two points during the seasons. |
| Overall study start date | 01/09/2023 |
| Completion date | 30/07/2027 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Mixed |
| Lower age limit | 12 Years |
| Upper age limit | 40 Years |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | 1. A player and active in the Real Sociedad football team 2. Signed the informed consent to participate |
| Key exclusion criteria | 1. Not being playing due to health reasons. 2. Not having signed the informed consent form. |
| Date of first enrolment | 25/09/2024 |
| Date of final enrolment | 30/07/2026 |
Locations
Countries of recruitment
- Spain
Study participating centres
Donostia-San Sebastián
20014
Spain
Derio
48160
Spain
Barcelona
08960
Spain
Sponsor information
Research organisation
Astondo Bidea, Edificio 609
Derio
48160
Spain
| Phone | +34 946 574 000 |
|---|---|
| info@azti.es | |
| Website | https://www.azti.es/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 20/12/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | Due to privacy concerns data will not be available since it could potentially be used to identify individual participants. As they are professional football players data such as date of birth or height is public and might be used for their identification. |
Editorial Notes
20/11/2024: Trial's existence confirmed by Research Ethics Committee of the Gipuzkoa Healthcare Area.
