Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-31 @ 10:18 PM
Study NCT ID:
NCT06534567
Status:
RECRUITING
Last Update Posted:
2024-08-05
First Post:
2024-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Body Composition, Growth, and Maturation of Triathletes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001836', 'term': 'Body Weight Changes'}], 'ancestors': [{'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D038441', 'term': 'Diet, Mediterranean'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D000095500', 'term': 'Diet, Plant-Based'}, {'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-01', 'studyFirstSubmitDate': '2024-07-30', 'studyFirstSubmitQcDate': '2024-07-30', 'lastUpdatePostDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Body Composition', 'timeFrame': '5 years', 'description': 'Change in body composition (fat mass and muscle mass) by anthropometric evaluation'}], 'secondaryOutcomes': [{'measure': 'Physical Activity Level', 'timeFrame': '5 years', 'description': 'Low, moderate or high'}, {'measure': 'Mediterranean Diet Adherence', 'timeFrame': '5 years', 'description': 'Low, moderate or high'}, {'measure': 'Biological Maturation Status', 'timeFrame': '5 years', 'description': 'early, average or late maturers'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diet Habit', 'Body Weight Changes']}, 'referencesModule': {'references': [{'pmid': '36518299', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '35402095', 'type': 'BACKGROUND', 'citation': 'Albaladejo-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.'}, {'pmid': '33466291', 'type': 'BACKGROUND', 'citation': 'Albaladejo-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.'}, {'pmid': '11932580', 'type': 'BACKGROUND', 'citation': 'Mirwald 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.'}, {'pmid': '27793062', 'type': 'BACKGROUND', 'citation': 'Moran 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.'}]}, 'descriptionModule': {'briefSummary': '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:\n\n• 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.', 'detailedDescription': '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.\n\nRegarding 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.\n\nDuring 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Young triathletes belonging to the ADESAVI triathlon club from the city of San Vicente del Raspeig (Spain)', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acceptation of informed consent by parents\n\nExclusion Criteria:\n\n* No attendance to body composition evaluation\n* Reporting less than 80% of assistance to physical activity sessions reported by trainer'}, 'identificationModule': {'nctId': 'NCT06534567', 'briefTitle': 'Body Composition, Growth, and Maturation of Triathletes', 'organization': {'class': 'OTHER', 'fullName': 'University of Alicante'}, 'officialTitle': 'Association of Body Composition, Growth, and Maturation Status With Physical Activity and Adherence With Mediterranean Diet in Youth Triathletes', 'orgStudyIdInfo': {'id': 'UA-2021-11-17'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Male', 'description': 'Young male triathletes', 'interventionNames': ['Other: Mediterranean Diet', 'Other: Physical activity']}, {'label': 'Female', 'description': 'Young female triathletes', 'interventionNames': ['Other: Mediterranean Diet', 'Other: Physical activity']}], 'interventions': [{'name': 'Mediterranean Diet', 'type': 'OTHER', 'description': 'Mediterranean diet adherence', 'armGroupLabels': ['Female', 'Male']}, {'name': 'Physical activity', 'type': 'OTHER', 'description': 'Physical activity level', 'armGroupLabels': ['Female', 'Male']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30690', 'city': 'San Vicent del Raspeig', 'state': 'Alicante', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Manuel Fernández Alcántar, Dr.', 'role': 'CONTACT', 'email': 'mfernandeza@ua.es', 'phone': '+34965903400', 'phoneExt': '2236'}], 'facility': 'Faculty of Health Sciences. University of Alicante.', 'geoPoint': {'lat': 38.3964, 'lon': -0.5255}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data are available from the authors on request from the IP JMMS (josemiguel.ms@ua.es).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alicante', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor. Director of the Research Group on Applied Dietetics, Nutrition and Body Composition. Nursing Department. Faculty of Health Sciences. University of Alicante.', 'investigatorFullName': 'Jose Miguel Martinez Sanz', 'investigatorAffiliation': 'University of Alicante'}}}}