Diet HabitNCT06534567
Body Composition, Growth, and Maturation of Triathletes
An observational study of Diet Habit and Body Weight Changes, run by University of Alicante at 1 site in Spain.
Trial summary
The goal of this observational study is to determine if physical activity and the adherence to a Mediterranean diet have a relationship with body composition, growth, and maturation status in youth triathletes. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Diet Habit, Body Weight Changes
- What is being tested?
- Mediterranean Diet and Physical activity
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2021to 30 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- Child
Study population: Young triathletes belonging to the ADESAVI triathlon club from the city of San Vicente del Raspeig (Spain)
Who may be able to join
- Acceptation of informed consent by parents
Who cannot join
- No attendance to body composition evaluation
- Reporting less than 80% of assistance to physical activity sessions reported by trainer
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Faculty of Health Sciences. University of Alicante.
San Vicent del Raspeig, Alicante, 30690
Manuel Fernández Alcántar, Dr., +34965903400 ext. 2236, mfernandeza@ua.es
About this study
Official title: Association of Body Composition, Growth, and Maturation Status With Physical Activity and Adherence With Mediterranean Diet in Youth Triathletes
The goal of this observational study is to determine if physical activity and the adherence to a Mediterranean diet have a relationship with body composition, growth, and maturation status in youth triathletes. The main question it aims to answer is:
- Is body composition (fat and muscle) determined primarily by growth and biological maturation or by physical activity and the Mediterranean diet in youth triathletes? Participants already have been evaluated in body composition, mediterranean diet adherence and practical of physical activity during 3 years.
Read the detailed description
Triathlon is an individual, multidisciplinary and resistance sport with three stages: swimming, cycling and running, linked by two transitions. The importance of knowing body composition, eating patterns, level of physical activity and maturational state, will allow influence on training, increasing sports performance.
Regarding body composition and its relationship with performance, it has been observed that the greater the body fat, the lower the physical performance of triathletes. In each sport, athletes have different composition somatotypes. For triathlon, it is difficult to establish a specific somatotype, since it is a modality that encompasses three sports, among which the anthropometric characteristics of the athletes who practice them are not similar. In addition, since it is a relatively new category, there are not enough bibliographical references regarding anthropometry and body composition.
During biological maturation, there is an increase in the basal metabolic rate, so an optimal diet helps the growth process and improves the performance and recovery of athletes. Therefore, in the early stages of childhood and adolescence, adherence to the diet plays an important role in the acquisition of healthy lifestyles to determine an optimal state of health. The Mediterranean Diet model is associated with healthy eating habits, high levels of quality of life and physical benefits.
- Conditions
- Diet Habit, Body Weight Changes
- Being tested
- Mediterranean Diet, Physical activity
- Medical subject headings
- Feeding Behavior, Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean DietOther
Mediterranean diet adherence
Physical activityOther
Physical activity level
| Study group | Role | What they receive |
|---|---|---|
| Male | Young male triathletes Receives: Other: Mediterranean Diet; Other: Physical activity | |
| Female | Young female triathletes Receives: Other: Mediterranean Diet; Other: Physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Body Composition
Change in body composition (fat mass and muscle mass) by anthropometric evaluation
Measured: 5 years
Secondary outcomes (3)
Physical Activity Level
Low, moderate or high
Measured: 5 years
Mediterranean Diet Adherence
Low, moderate or high
Measured: 5 years
Biological Maturation Status
early, average or late maturers
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start1 Nov 2021
- Primary completion30 Nov 2021
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diet HabitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alicante
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Miguel Martinez Sanz, University of Alicante
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06534567
- Sponsor's protocol ID
- UA-2021-11-17
- Status last verified
- Aug 2024
- First submitted
- 30 Jul 2024
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data are available from the authors on request from the IP JMMS (josemiguel.ms@ua.es).
Publications
Romero-Garcia D, Esparza-Ros F, Pico Garcia M, Martinez-Sanz JM, Vaquero-Cristobal R. Adherence to the Mediterranean diet, kinanthropometric characteristics and physical performance of young male handball players. PeerJ. 2022 Dec 1;10:e14329. doi: 10.7717/peerj.14329. eCollection 2022.
PubMed 36518299Albaladejo-Saura M, Vaquero-Cristobal R, Garcia-Roca JA, Esparza-Ros F. Influence of biological maturation status on selected anthropometric and physical fitness variables in adolescent male volleyball players. PeerJ. 2022 Apr 5;10:e13216. doi: 10.7717/peerj.13216. eCollection 2022.
PubMed 35402095Albaladejo-Saura M, Vaquero-Cristobal R, Gonzalez-Galvez N, Esparza-Ros F. Relationship between Biological Maturation, Physical Fitness, and Kinanthropometric Variables of Young Athletes: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2021 Jan 5;18(1):328. doi: 10.3390/ijerph18010328.
PubMed 33466291Mirwald RL, Baxter-Jones AD, Bailey DA, Beunen GP. An assessment of maturity from anthropometric measurements. Med Sci Sports Exerc. 2002 Apr;34(4):689-94. doi: 10.1097/00005768-200204000-00020.
PubMed 11932580Moran J, Sandercock G, Rumpf MC, Parry DA. Variation in Responses to Sprint Training in Male Youth Athletes: A Meta-analysis. Int J Sports Med. 2017 Jan;38(1):1-11. doi: 10.1055/s-0042-111439. Epub 2016 Oct 28.
PubMed 27793062
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Body Composition, Growth, and Maturation Status With Physical Activity and Adherence With Mediterranean Diet in Youth Triathletes
- ClinicalTrials.gov ID
- NCT06534567
- Acronym / sponsor ID
- UA-2021-11-17
- Conditions
- Diet Habit, Body Weight Changes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of AlicanteUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 2 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to determine if physical activity and the adherence to a Mediterranean diet have a relationship with body composition, growth, and maturation status in youth triathletes. The main question it aims to answer is:
- Is body composition (fat and muscle) determined primarily by growth and biological maturation or by physical activity and the Mediterranean diet in youth triathletes? Participants already have been evaluated in body composition, mediterranean diet adherence and practical of physical activity during 3 years.
Detailed description
Triathlon is an individual, multidisciplinary and resistance sport with three stages: swimming, cycling and running, linked by two transitions. The importance of knowing body composition, eating patterns, level of physical activity and maturational state, will allow influence on training, increasing sports performance.
Regarding body composition and its relationship with performance, it has been observed that the greater the body fat, the lower the physical performance of triathletes. In each sport, athletes have different composition somatotypes. For triathlon, it is difficult to establish a specific somatotype, since it is a modality that encompasses three sports, among which the anthropometric characteristics of the athletes who practice them are not similar. In addition, since it is a relatively new category, there are not enough bibliographical references regarding anthropometry and body composition.
During biological maturation, there is an increase in the basal metabolic rate, so an optimal diet helps the growth process and improves the performance and recovery of athletes. Therefore, in the early stages of childhood and adolescence, adherence to the diet plays an important role in the acquisition of healthy lifestyles to determine an optimal state of health. The Mediterranean Diet model is associated with healthy eating habits, high levels of quality of life and physical benefits.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Male | – | Other: Mediterranean Diet, Other: Physical activityYoung male triathletes |
| Female | – | Other: Mediterranean Diet, Other: Physical activityYoung female triathletes |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- Young triathletes belonging to the ADESAVI triathlon club from the city of San Vicente del Raspeig (Spain)
Key inclusion criteria (1 listed)
- Acceptation of informed consent by parents
Key exclusion criteria (2 listed)
- No attendance to body composition evaluation
- Reporting less than 80% of assistance to physical activity sessions reported by trainer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mediterranean DietMediterranean diet adherence | Other | Female, Male |
| Physical activityPhysical activity level | Other | Female, Male |
Primary outcome
Changes in Body Composition
Time frame: 5 years
Change in body composition (fat mass and muscle mass) by anthropometric evaluation
3 secondary outcomes
Physical Activity Level
Time frame: 5 years
Mediterranean Diet Adherence
Time frame: 5 years
Biological Maturation Status
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Background: PubMed 36518299Romero-Garcia D, Esparza-Ros F, Pico Garcia M, Martinez-Sanz JM, Vaquero-Cristobal R. Adherence to the Mediterranean diet, kinanthropometric characteristics and physical performance of young male handball players. PeerJ. 2022 Dec 1;10:e14329. doi: 10.7717/peerj.14329. eCollection 2022.
- Background: PubMed 35402095Albaladejo-Saura M, Vaquero-Cristobal R, Garcia-Roca JA, Esparza-Ros F. Influence of biological maturation status on selected anthropometric and physical fitness variables in adolescent male volleyball players. PeerJ. 2022 Apr 5;10:e13216. doi: 10.7717/peerj.13216. eCollection 2022.
- Background: PubMed 33466291Albaladejo-Saura M, Vaquero-Cristobal R, Gonzalez-Galvez N, Esparza-Ros F. Relationship between Biological Maturation, Physical Fitness, and Kinanthropometric Variables of Young Athletes: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2021 Jan 5;18(1):328. doi: 10.3390/ijerph18010328.
- Background: PubMed 11932580Mirwald RL, Baxter-Jones AD, Bailey DA, Beunen GP. An assessment of maturity from anthropometric measurements. Med Sci Sports Exerc. 2002 Apr;34(4):689-94. doi: 10.1097/00005768-200204000-00020.
- Background: PubMed 27793062Moran J, Sandercock G, Rumpf MC, Parry DA. Variation in Responses to Sprint Training in Male Youth Athletes: A Meta-analysis. Int J Sports Med. 2017 Jan;38(1):1-11. doi: 10.1055/s-0042-111439. Epub 2016 Oct 28.
- Individual participant dataSharing planned: No. The data are available from the authors on request from the IP JMMS (josemiguel.ms@ua.es).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faculty of Health Sciences. University of Alicante.
San Vicent del Raspeig, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diet Habit and Body Weight Changes, run by University of Alicante at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Body Composition (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06534567, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2024.