Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 5:41 AM
Study NCT ID:
NCT07438158
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-02
First Post:
2026-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Protein Distribution and Leucine Supplementation Effects on Body Composition and Performance in Tactical Athletes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Due to the nature of the dietary intervention and differences in meal timing, participants and study personnel responsible for dietary supervision are not blinded to group allocation. Laboratory analyses of biochemical outcomes may be performed without knowledge of group assignment.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a three-arm, parallel-group randomized controlled trial. Participants will be randomly assigned in a 1:1:1 ratio to one of three dietary intervention groups (EVEN, FAST, FAST-RESCUE) for 8 weeks during an intensive tactical training program. Each group will follow a distinct protein distribution strategy while maintaining identical total daily protein intake (1.6 g/kg/day) and iso-caloric energy intake.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 69}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-26', 'studyFirstSubmitDate': '2026-02-22', 'studyFirstSubmitQcDate': '2026-02-22', 'lastUpdatePostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Lean Body Mass (LBM)', 'timeFrame': 'Baseline (Week 1) to Week 8', 'description': 'Lean body mass (kg) assessed by multi-frequency bioelectrical impedance analysis (BIA) using the SECA mBCA 515.'}], 'secondaryOutcomes': [{'measure': 'Change in Fat Mass Percentage', 'timeFrame': 'Baseline (Week 1), Week 5, and Week 8', 'description': 'Fat mass percentage (%) assessed by multi-frequency bioelectrical impedance analysis (SECA mBCA 515).'}, {'measure': 'Change in Fat-Free Mass (FFM)', 'timeFrame': 'Baseline (Week 1), Week 5, and Week 8', 'description': 'Fat-free mass (kg) assessed by multi-frequency bioelectrical impedance analysis (SECA mBCA 515).'}, {'measure': 'Change in Skeletal Muscle Mass (SMM)', 'timeFrame': 'Baseline (Week 1), Week 5, and Week 8', 'description': 'Skeletal muscle mass (kg) assessed by multi-frequency bioelectrical impedance analysis (SECA mBCA 515).'}, {'measure': 'Change in Maximal Strength - Isometric Mid-Thigh Pull (IMTP)', 'timeFrame': 'Baseline (Week 1), Week 5, and Week 8', 'description': 'Maximal force during IMTP measured using a force plate system (k-Delta). Best of two trials recorded.'}, {'measure': 'Change in Maximal Voluntary Isometric Contraction (MVC)', 'timeFrame': 'Baseline (Week 1), Week 5, and Week 8', 'description': 'Knee extension MVC force measured using a strain gauge system. Best of trials recorded per protocol procedures.'}, {'measure': 'Change in Handgrip Strength', 'timeFrame': 'Baseline (Week 1), Week 5, and Week 8', 'description': 'Handgrip strength measured with a handgrip dynamometer; best value recorded.'}, {'measure': 'Change in Countermovement Jump (CMJ) Performance', 'timeFrame': 'Baseline (Week 1), Week 5, and Week 8', 'description': 'Jump height measured via force plate system; best of two trials recorded.'}, {'measure': 'Change in Peak Power Output (Wingate Test)', 'timeFrame': 'Baseline (Week 1), Week 5, and Week 8', 'description': 'Peak power output (W) during a 30-second Wingate Anaerobic Test performed on a cycle ergometer.'}, {'measure': 'Change in Mean Power Output (Wingate Test)', 'timeFrame': 'Baseline (Week 1), Week 5, and Week 8', 'description': 'Mean power output (W) during a 30-second Wingate Anaerobic Test performed on a cycle ergometer.'}, {'measure': 'Change in Urinary Titin N-terminal Fragment to Creatinine Ratio (UTF/Cr)', 'timeFrame': 'Baseline (Week 1) and Week 5', 'description': 'Urinary titin N-terminal fragment (UTF) normalized to creatinine as a biomarker of myofibrillar damage, assessed from morning urine samples using ELISA methods described in the protocol.'}, {'measure': 'Change in Serum Creatine Kinase (CK)', 'timeFrame': 'Baseline (Week 1), Week 5, and Week 8', 'description': 'Serum CK concentration measured from blood samples as a marker of muscle damage.'}, {'measure': 'Change in Serum Urea (Blood Urea Nitrogen, BUN)', 'timeFrame': 'Baseline (Week 1), Week 5, and Week 8', 'description': 'Serum urea concentration (mg/dL or mmol/L) measured from venous blood samples.'}, {'measure': 'Change in Total Testosterone', 'timeFrame': 'Baseline (Week 1), Week 5, and Week 8', 'description': 'Serum total testosterone measured from blood samples.'}, {'measure': 'Change in C-Reactive Protein (CRP)', 'timeFrame': 'Baseline (Week 1), Week 5, and Week 8', 'description': 'Serum C-reactive protein concentration (mg/L) measured from venous blood samples.'}, {'measure': 'Change in Tumor Necrosis Factor-alpha (TNF-α)', 'timeFrame': 'Baseline (Week 1), Week 5, and Week 8', 'description': 'Serum TNF-α concentration (pg/mL) measured from venous blood samples.'}, {'measure': 'Change in Interleukin-6 (IL-6)', 'timeFrame': 'Baseline (Week 1), Week 5, and Week 8', 'description': 'Serum IL-6 concentration (pg/mL) measured from venous blood samples.'}, {'measure': 'Change in Resting Metabolic Rate (RMR)', 'timeFrame': 'Baseline (Week 1) and Week 8', 'description': 'Resting metabolic rate (kcal/day) assessed by indirect calorimetry using a metabolic cart under standardized fasting conditions.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tactical Athletes', 'Protein Distribution', 'Leucine Supplementation', 'Lean Body Mass', 'Muscle Protein Synthesis', 'Resistance Training'], 'conditions': ['Muscle Damage']}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial will examine the effects of within-day protein distribution and leucine supplementation on body composition, physical performance, and biomarkers of muscle damage in tactical athletes during an 8-week intensive training program. Sixty-nine healthy male participants (18-35 years) enrolled in a Ministry of Defense training course will be randomly assigned to one of three iso-caloric dietary groups providing 1.6 g/kg/day of protein: (1) evenly distributed protein across three meals (EVEN), (2) a 16-hour daily protein fasting pattern with protein concentrated at lunch and dinner (FAST), or (3) the same fasting pattern with 5 g leucine supplementation at breakfast (FAST-RESCUE).\n\nPrimary outcomes include changes in lean body mass. Secondary outcomes include strength, anaerobic performance, and biochemical markers of muscle damage, including urinary titin N-terminal fragment (UTF). Assessments will be conducted at baseline, Week 5, and Week 8.', 'detailedDescription': 'This study is an 8-week, three-arm, parallel-group randomized controlled trial conducted in healthy male tactical trainees (18-35 years) enrolled in a Ministry of Defense training program. Participants will undergo a high-volume concurrent training regimen exceeding 30 hours per week, including resistance training, load carriage, aerobic conditioning, and combat-based drills.\n\nParticipants (n=69) will be randomized in a 1:1:1 ratio to one of three iso-caloric dietary interventions providing 1.6 g/kg/day of protein:\n\n1. EVEN: Protein evenly distributed across three daily meals (08:00, 13:00, 18:00).\n2. FAST: Skewed protein distribution with a 16-hour protein-free window (21:00-13:00), omitting protein at breakfast and concentrating intake at lunch and dinner.\n3. FAST-RESCUE: Identical to FAST, with addition of 5 g free-form leucine consumed at breakfast.\n\nEnergy intake will be individualized based on measured resting metabolic rate and estimated physical activity level. Dietary adherence will be monitored daily using a mobile application and weekly dietitian supervision.\n\nPrimary Outcome:\n\n\\- Change in lean body mass measured by bioelectrical impedance analysis from baseline to Week 8.\n\nSecondary Outcomes:\n\n* Maximal strength (isometric mid-thigh pull, maximal voluntary contraction, handgrip strength)\n* Anaerobic performance (Wingate test, countermovement jump)\n* Serum biomarkers (creatine kinase, urea, testosterone, inflammatory markers)\n* Urinary titin N-terminal fragment to creatinine ratio (UTF/Cr) as a marker of myofibrillar damage\n\nAssessments will be performed at baseline, Week 5, and Week 8. Data will be analyzed according to the intention-to-treat principle using linear mixed models to evaluate Group × Time interactions.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male participants aged 18-35 years\n* Enrolled in an active Ministry of Defense tactical training program\n* Physically active and medically cleared to participate in intensive training\n* Willing and able to comply with the dietary intervention and training protocol\n* Provide written informed consent prior to participation\n\nExclusion Criteria:\n\n* Musculoskeletal or neuromuscular injury or impairment limiting participation in exercise training\n* Cardiopulmonary disease (including recent myocardial infarction or unstable angina)\n* History of cancer, diabetes, thyroid disease, hypertension, or chronic renal failure\n* Cognitive impairment affecting ability to provide informed consent\n* Use of medications that may affect metabolism, muscle physiology, or exercise performance\n* Known allergy or intolerance to study dietary components or leucine supplementation\n* Non-compliance with study protocol requirements'}, 'identificationModule': {'nctId': 'NCT07438158', 'briefTitle': 'Protein Distribution and Leucine Supplementation Effects on Body Composition and Performance in Tactical Athletes', 'organization': {'class': 'OTHER', 'fullName': 'Tel Aviv University'}, 'officialTitle': 'The Effect of Protein Distribution and Leucine Supplementation on Body Composition, Physical Performance, and Myofibrillar Damage in Tactical Athletes: a Randomized Controlled Trial During 8 Weeks of Intensive Training', 'orgStudyIdInfo': {'id': '0011980-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'EVEN (Even Protein Distribution)', 'description': 'Participants consume an iso-caloric diet providing 1.6 g/kg/day protein, distributed evenly across three daily meals at approximately 08:00, 13:00, and 18:00, with each meal providing \\~one-third of daily protein. Participants follow an overnight protein fasting window of approximately 21:00-08:00.', 'interventionNames': ['Behavioral: Even Protein Distribution']}, {'type': 'EXPERIMENTAL', 'label': 'FAST (Protein-Fasting Morning; Protein at Lunch + Dinner)', 'description': 'Participants consume an iso-caloric diet providing 1.6 g/kg/day protein using a skewed distribution that creates a 16-hour protein-free window (21:00-13:00) by omitting protein at breakfast (breakfast contains carbohydrate and fat only). Daily protein intake is concentrated at lunch and dinner to achieve the total 1.6 g/kg/day target.', 'interventionNames': ['Behavioral: Skewed Protein Distribution (16-hour Protein-Fasting Window)']}, {'type': 'EXPERIMENTAL', 'label': 'FAST-RESCUE (FAST + Leucine at Breakfast)', 'description': 'Identical dietary pattern to FAST: iso-caloric diet with 1.6 g/kg/day protein, protein-free breakfast, and protein concentrated at lunch and dinner, creating a 16-hour protein-free window (21:00-13:00).', 'interventionNames': ['Dietary Supplement: L-leucine supplementation']}], 'interventions': [{'name': 'L-leucine supplementation', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants ingest 5 g free-form L-leucine at breakfast (\\~08:00) daily for 8 weeks. Leucine is provided as unflavored, pharmaceutical-grade instantized powder, reconstituted in water and consumed at the protein-free breakfast meal.', 'armGroupLabels': ['FAST-RESCUE (FAST + Leucine at Breakfast)']}, {'name': 'Even Protein Distribution', 'type': 'BEHAVIORAL', 'description': 'Iso-caloric diet providing 1.6 g/kg/day protein evenly distributed across three daily meals for 8 weeks.', 'armGroupLabels': ['EVEN (Even Protein Distribution)']}, {'name': 'Skewed Protein Distribution (16-hour Protein-Fasting Window)', 'type': 'BEHAVIORAL', 'description': 'Iso-caloric diet providing 1.6 g/kg/day protein with protein omitted at breakfast and concentrated at lunch and dinner, creating a 16-hour daily protein-free window for 8 weeks.', 'armGroupLabels': ['FAST (Protein-Fasting Morning; Protein at Lunch + Dinner)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Lien Bruck', 'role': 'CONTACT', 'email': 'lien.brueck@gmail.com', 'phone': '0587487431'}, {'name': 'Lien Bruck', 'role': 'CONTACT', 'email': 'lien.bruck@tauex.tau.ac.il', 'phone': '0587487431'}], 'overallOfficials': [{'name': 'Yftach Gepner, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tel Aviv University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tel Aviv University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator - Professor', 'investigatorFullName': 'Gepner Yftach', 'investigatorAffiliation': 'Tel Aviv University'}}}}