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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).
Primary 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.
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.
Participants (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:
Energy 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.
Primary Outcome:
- Change in lean body mass measured by bioelectrical impedance analysis from baseline to Week 8.
Secondary Outcomes:
Assessments 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EVEN (Even Protein Distribution) | Other | 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. |
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| FAST (Protein-Fasting Morning; Protein at Lunch + Dinner) | Experimental | 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. |
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| FAST-RESCUE (FAST + Leucine at Breakfast) | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-leucine supplementation | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Lean Body Mass (LBM) | Lean body mass (kg) assessed by multi-frequency bioelectrical impedance analysis (BIA) using the SECA mBCA 515. | Baseline (Week 1) to Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fat Mass Percentage | Fat mass percentage (%) assessed by multi-frequency bioelectrical impedance analysis (SECA mBCA 515). | Baseline (Week 1), Week 5, and Week 8 |
| Change in Fat-Free Mass (FFM) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lien Bruck | Contact | 0587487431 | lien.brueck@gmail.com | |
| Lien Bruck | Contact | 0587487431 | lien.bruck@tauex.tau.ac.il |
| Name | Affiliation | Role |
|---|---|---|
| Yftach Gepner, PhD | Tel Aviv University | Principal Investigator |
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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.
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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.
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| Even Protein Distribution | Behavioral | Iso-caloric diet providing 1.6 g/kg/day protein evenly distributed across three daily meals for 8 weeks. |
|
| Skewed Protein Distribution (16-hour Protein-Fasting Window) | Behavioral | 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. |
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Fat-free mass (kg) assessed by multi-frequency bioelectrical impedance analysis (SECA mBCA 515).
| Baseline (Week 1), Week 5, and Week 8 |
| Change in Skeletal Muscle Mass (SMM) | Skeletal muscle mass (kg) assessed by multi-frequency bioelectrical impedance analysis (SECA mBCA 515). | Baseline (Week 1), Week 5, and Week 8 |
| Change in Maximal Strength - Isometric Mid-Thigh Pull (IMTP) | Maximal force during IMTP measured using a force plate system (k-Delta). Best of two trials recorded. | Baseline (Week 1), Week 5, and Week 8 |
| Change in Maximal Voluntary Isometric Contraction (MVC) | Knee extension MVC force measured using a strain gauge system. Best of trials recorded per protocol procedures. | Baseline (Week 1), Week 5, and Week 8 |
| Change in Handgrip Strength | Handgrip strength measured with a handgrip dynamometer; best value recorded. | Baseline (Week 1), Week 5, and Week 8 |
| Change in Countermovement Jump (CMJ) Performance | Jump height measured via force plate system; best of two trials recorded. | Baseline (Week 1), Week 5, and Week 8 |
| Change in Peak Power Output (Wingate Test) | Peak power output (W) during a 30-second Wingate Anaerobic Test performed on a cycle ergometer. | Baseline (Week 1), Week 5, and Week 8 |
| Change in Mean Power Output (Wingate Test) | Mean power output (W) during a 30-second Wingate Anaerobic Test performed on a cycle ergometer. | Baseline (Week 1), Week 5, and Week 8 |
| Change in Urinary Titin N-terminal Fragment to Creatinine Ratio (UTF/Cr) | 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. | Baseline (Week 1) and Week 5 |
| Change in Serum Creatine Kinase (CK) | Serum CK concentration measured from blood samples as a marker of muscle damage. | Baseline (Week 1), Week 5, and Week 8 |
| Change in Serum Urea (Blood Urea Nitrogen, BUN) | Serum urea concentration (mg/dL or mmol/L) measured from venous blood samples. | Baseline (Week 1), Week 5, and Week 8 |
| Change in Total Testosterone | Serum total testosterone measured from blood samples. | Baseline (Week 1), Week 5, and Week 8 |
| Change in C-Reactive Protein (CRP) | Serum C-reactive protein concentration (mg/L) measured from venous blood samples. | Baseline (Week 1), Week 5, and Week 8 |
| Change in Tumor Necrosis Factor-alpha (TNF-α) | Serum TNF-α concentration (pg/mL) measured from venous blood samples. | Baseline (Week 1), Week 5, and Week 8 |
| Change in Interleukin-6 (IL-6) | Serum IL-6 concentration (pg/mL) measured from venous blood samples. | Baseline (Week 1), Week 5, and Week 8 |
| Change in Resting Metabolic Rate (RMR) | Resting metabolic rate (kcal/day) assessed by indirect calorimetry using a metabolic cart under standardized fasting conditions. | Baseline (Week 1) and Week 8 |