Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-30 @ 9:45 PM
Study NCT ID:
NCT07104669
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-05
First Post:
2025-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sports Nutrition Assessment Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D014008', 'term': 'Tinea Pedis'}], 'ancestors': [{'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014005', 'term': 'Tinea'}, {'id': 'D003881', 'term': 'Dermatomycoses'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D005533', 'term': 'Foot Dermatoses'}, {'id': 'D005534', 'term': 'Foot Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D011537', 'term': 'Pruritus'}, {'id': 'D012877', 'term': 'Skin Manifestations'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004032', 'term': 'Diet'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D001823', 'term': 'Body Composition'}, {'id': 'D000074267', 'term': 'Organism Hydration Status'}, {'id': 'D006304', 'term': 'Health Status'}], 'ancestors': [{'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'}, {'id': 'D001669', 'term': 'Biochemical Phenomena'}, {'id': 'D055598', 'term': 'Chemical Phenomena'}, {'id': 'D008660', 'term': 'Metabolism'}, {'id': 'D001824', 'term': 'Body Constitution'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2031-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-29', 'studyFirstSubmitDate': '2025-07-29', 'studyFirstSubmitQcDate': '2025-07-29', 'lastUpdatePostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diet Adherence', 'timeFrame': '5 years', 'description': 'Low, moderate or high'}], 'secondaryOutcomes': [{'measure': 'Physical Activity Level', 'timeFrame': '5 years', 'description': 'Low, moderate or high'}, {'measure': 'Changes in Body Composition', 'timeFrame': '5 years', 'description': 'Change in body composition (fat mass and muscle mass) by anthropometric evaluation'}, {'measure': 'Hydration status', 'timeFrame': '5 years', 'description': 'normohydrated, dehydrated, very dehydrated'}, {'measure': 'perception of health status', 'timeFrame': '5 years', 'description': 'very good, good, average, bad, very bad'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sport nutrition', 'dietary-nutritional assessment', 'athletes', 'questionnaires'], 'conditions': ['Diet Habit', 'Body Weight', 'Athlete Foot']}, 'referencesModule': {'references': [{'pmid': '27270749', 'type': 'BACKGROUND', 'citation': 'Lachat C, Hawwash D, Ocke MC, Berg C, Forsum E, Hornell A, Larsson C, Sonestedt E, Wirfalt E, Akesson A, Kolsteren P, Byrnes G, De Keyzer W, Van Camp J, Cade JE, Slimani N, Cevallos M, Egger M, Huybrechts I. Strengthening the Reporting of Observational Studies in Epidemiology-Nutritional Epidemiology (STROBE-nut): An Extension of the STROBE Statement. PLoS Med. 2016 Jun 7;13(6):e1002036. doi: 10.1371/journal.pmed.1002036. eCollection 2016 Jun.'}, {'pmid': '39641837', 'type': 'BACKGROUND', 'citation': 'Serafini S, Charrier D, Izzicupo P, Esparza-Ros F, Vaquero-Cristobal R, Petri C, Mecherques-Carini M, Baglietto N, Holway F, Tinsley G, Paoli A, Campa F. Anthropometric-based predictive equations developed with multi-component models for estimating body composition in athletes. Eur J Appl Physiol. 2025 Mar;125(3):595-610. doi: 10.1007/s00421-024-05672-3. Epub 2024 Dec 6.'}, {'pmid': '38542815', 'type': 'BACKGROUND', 'citation': 'Sebastia-Rico J, Soriano JM, Sanchis-Chorda J, Garcia-Fernandez AF, Lopez-Mateu P, de la Cruz Marcos S, Martinez-Sanz JM. Analysis of Fluid Balance and Urine Values in Elite Soccer Players: Impact of Different Environments, Playing Positions, Sexes, and Competitive Levels. Nutrients. 2024 Mar 21;16(6):903. doi: 10.3390/nu16060903.'}, {'pmid': '29207495', 'type': 'BACKGROUND', 'citation': "Capling L, Beck KL, Gifford JA, Slater G, Flood VM, O'Connor H. Validity of Dietary Assessment in Athletes: A Systematic Review. Nutrients. 2017 Dec 2;9(12):1313. doi: 10.3390/nu9121313."}]}, 'descriptionModule': {'briefSummary': 'The NutriEvalUA program is an observational study aiming to assess the nutritional status, body composition, hydration, physical activity, and health indicators in university athletes. The main objective is to describe and evaluate dietary habits, supplement use, physical condition, and related risk factors to improve health and sports performance in this population. The main question it aims to answer is: What is the nutritional, body composition, hydration, physical activity, and general health profile of university athletes at the University of Alicante, and which factors are associated with potential risks to their performance and well-being?', 'detailedDescription': 'University athletes represent a population with specific nutritional and physiological needs. Despite their active lifestyle, there is often a lack of systematic evaluation protocols focused on their health and performance. NutriEvalUA addresses this gap through a comprehensive assessment protocol including anthropometry, body composition, dietary habits, physical activity levels, hydration status, and health-related questionnaires (e.g., sleep, disordered eating, exercise addiction).\n\nThis cohort study is carried out in collaboration with sports teams affiliated with the University of Alicante. The information obtained will help identify patterns, risks, and opportunities for nutritional intervention, supporting evidence-based strategies to optimize performance and promote long-term health.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "University athletes who train and compete on the University of Alicante's sports teams", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acceptation of informed consent\n\nExclusion Criteria:\n\n* No attendance to the evaluations\n* Reporting less than 80% of assistance to physical activity sessions reported by trainer'}, 'identificationModule': {'nctId': 'NCT07104669', 'acronym': 'NutriEvalUA', 'briefTitle': 'Sports Nutrition Assessment Program', 'organization': {'class': 'OTHER', 'fullName': 'University of Alicante'}, 'officialTitle': 'Sports Nutrition Assessment Program at the University of Alicante', 'orgStudyIdInfo': {'id': 'UA-2025-07-15'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'male', 'description': 'adults male athletes', 'interventionNames': ['Other: diet', 'Other: Physical activity', 'Other: body composition', 'Other: hydration status', 'Other: health status']}, {'label': 'female', 'description': 'adults female athletes', 'interventionNames': ['Other: diet', 'Other: Physical activity', 'Other: body composition', 'Other: hydration status', 'Other: health status']}], 'interventions': [{'name': 'diet', 'type': 'OTHER', 'description': 'diet adherence', 'armGroupLabels': ['female', 'male']}, {'name': 'Physical activity', 'type': 'OTHER', 'description': 'Physical activity level', 'armGroupLabels': ['female', 'male']}, {'name': 'body composition', 'type': 'OTHER', 'description': 'body composition assessment', 'armGroupLabels': ['female', 'male']}, {'name': 'hydration status', 'type': 'OTHER', 'description': 'hydration status assessment', 'armGroupLabels': ['female', 'male']}, {'name': 'health status', 'type': 'OTHER', 'description': 'perception of health status', 'armGroupLabels': ['female', 'male']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03690', 'city': 'San Vicent del Raspeig', 'state': 'Alicante', 'country': 'Spain', 'contacts': [{'name': 'Manuel Fernández Alcántara, 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}}], 'centralContacts': [{'name': 'Jose Miguel Martinez Sanz, Dr.', 'role': 'CONTACT', 'email': 'josemiguel.ms@ua.es', 'phone': '+34 620420726'}, {'name': 'David Romero García, Dr.', 'role': 'CONTACT', 'email': 'david.romero@ua.es'}]}, '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'}}}}