Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2026-01-01 @ 3:16 AM
Study NCT ID:
NCT04213456
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-15
First Post:
2019-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Double Blind, Randomized, Placebo Controlled Pilot Study to Evaluate the Effect of Nutritional Supplementation on Physical Activity Performance of Young Soccer Players
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-14', 'studyFirstSubmitDate': '2019-12-26', 'studyFirstSubmitQcDate': '2019-12-26', 'lastUpdatePostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Average daily caloric intake', 'timeFrame': 'at 4 months'}, {'measure': 'Average daily macronutrients intake', 'timeFrame': 'at 4 months'}, {'measure': 'Average daily micronutrients intake', 'timeFrame': 'at 4 months'}, {'measure': 'Average weekly duration of physical activity', 'timeFrame': 'at 4 months'}, {'measure': 'Average daily duration of sedentary activity', 'timeFrame': 'at 4 months'}], 'primaryOutcomes': [{'measure': 'Height SDS (standard deviation score)', 'timeFrame': 'at 4 months', 'description': "Change in standard deviation score of participant's height between baseline and 4 months"}, {'measure': '10m sprint score', 'timeFrame': 'at 4 months', 'description': 'Change in 10m sprint score between baseline and 4 months (test the speed and acceleration of the player)'}, {'measure': '20m sprint score', 'timeFrame': 'at 4 months', 'description': 'Change in 20m sprint score between baseline and 4 months (test the speed and acceleration of the player)'}, {'measure': 'Countermovement Jump (CMJ) score', 'timeFrame': 'at 4 months', 'description': 'Change in Countermovement Jump (CMJ) score between baseline and 4 months (assess explosive strength of the lower extremity muscles)'}, {'measure': 'Agility test score', 'timeFrame': 'at 4 months', 'description': 'Change in Agility test score between baseline and 4 months(agility is the ability to change the direction of the body rapidly and is a result of a combination of strength, speed, balance and coordination)'}, {'measure': 'The Yo-Yo Intermittent Recovery Test Level 1 (Yo-Yo IR1) score', 'timeFrame': 'at 4 months', 'description': 'Change in the Yo-Yo IR1 score between baseline and 4 months (The Yo-Yo IR test measure the ability to recover from intense exercise)'}], 'secondaryOutcomes': [{'measure': 'weight-SDS', 'timeFrame': 'at 4 months', 'description': "Change in standard deviation score of subject's weight between baseline and 4 months"}, {'measure': 'BMI-SDS', 'timeFrame': 'at 4 months', 'description': "Change in standard deviation score of subject's BMI between baseline and 4 months"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sport performance'], 'conditions': ['Nutritional Supplementation', 'Growth']}, 'descriptionModule': {'briefSummary': "Research has clearly shown that lacking sufficient calories, macro- and micro-nutrients may impair an athlete's training adaptations, while athletes who consume a balanced diet that meets energy needs can enhance physiological training adaptations. Maintaining an energy and nutrient deficient diet during training may lead to loss of muscle mass, strength, and bone mineral density, in addition to an increased susceptibility to illness and injuries, disturbances in immune, endocrine and reproductive function, and an increased prevalence of overreaching and/or overtraining. In children and adolescent athletes, an insufficient diet may additionally result in impaired physical growth. Incorporating good dietary practices as part of a training program is one way to help optimize training adaptations and prevent overtraining.\n\nBased on this, nutritional supplementation is an effective and safe approach for attaining the high nutritional requirements of adolescent athletes, to help them maintain healthy growth. Nutritional supplementation could also improve their body composition, sport performance and general health. The primary objective of the proposed study is to evaluate the effect of dietary supplement versus placebo on growth and physical activity performance in young athletes. A total of 50 young soccer players (25 in each group) will participate in this Double blind, randomized, placebo controlled study."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Young soccer players aged 8-15 years old\n\nExclusion Criteria:\n\n* Diagnosis of GH Deficiency or treatment with GH\n* Any known chronic disease or dysmorphic syndrome including: organic brain diseases, neurological disease, past or current malignancy, chronic cardiac, renal or pulmonary problems, gastrointestinal disease including malabsorption and bone dysplasia.'}, 'identificationModule': {'nctId': 'NCT04213456', 'briefTitle': 'Double Blind, Randomized, Placebo Controlled Pilot Study to Evaluate the Effect of Nutritional Supplementation on Physical Activity Performance of Young Soccer Players', 'organization': {'class': 'OTHER', 'fullName': 'Rabin Medical Center'}, 'officialTitle': 'Double Blind, Randomized, Placebo Controlled Pilot Study to Evaluate the Effect of Nutritional Supplementation on Physical Activity Performance of Young Soccer Players', 'orgStudyIdInfo': {'id': 'RMC0888-18ctil'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nutritional supplementation', 'description': 'Powder added to water,high protein and multi vitamin and minerals', 'interventionNames': ['Dietary Supplement: Nutritional Sport Formula']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Low caloric formula (Powder added to water), without added vitamins and minerals.', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Nutritional Sport Formula', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Powder added to water,high protein and multi vitamins and minerals', 'armGroupLabels': ['Nutritional supplementation']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Low caloric formula (Powder added to water), without added vitamins and minerals.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4920235', 'city': 'Petah Tikva', 'country': 'Israel', 'facility': "Schnider Children's Medical Center", 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rabin Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'NG Solutions Ltd', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}