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NCT Number: NCT07438158

Protein Distribution and Leucine Supplementation Effects on Body Composition and Performance in Tactical Athletes

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.

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Key information

Conditions

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

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:

  • EVEN: Protein evenly distributed across three daily meals (08:00, 13:00, 18:00).
  • 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.
  • FAST-RESCUE: Identical to FAST, with addition of 5 g free-form leucine consumed at breakfast.

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:

  • Maximal strength (isometric mid-thigh pull, maximal voluntary contraction, handgrip strength)
  • Anaerobic performance (Wingate test, countermovement jump)
  • Serum biomarkers (creatine kinase, urea, testosterone, inflammatory markers)
  • Urinary titin N-terminal fragment to creatinine ratio (UTF/Cr) as a marker of myofibrillar damage

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male participants aged 18-35 years
  • Enrolled in an active Ministry of Defense tactical training program
  • Physically active and medically cleared to participate in intensive training
  • Willing and able to comply with the dietary intervention and training protocol
  • Provide written informed consent prior to participation

Exclusion criteria

  • Musculoskeletal or neuromuscular injury or impairment limiting participation in exercise training
  • Cardiopulmonary disease (including recent myocardial infarction or unstable angina)
  • History of cancer, diabetes, thyroid disease, hypertension, or chronic renal failure
  • Cognitive impairment affecting ability to provide informed consent
  • Use of medications that may affect metabolism, muscle physiology, or exercise performance
  • Known allergy or intolerance to study dietary components or leucine supplementation
  • Non-compliance with study protocol requirements

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Lean Body Mass (LBM)

    Time frame: Baseline (Week 1) to Week 8

    Lean body mass (kg) assessed by multi-frequency bioelectrical impedance analysis (BIA) using the SECA mBCA 515.

Secondary outcomes

  1. Change in Fat Mass Percentage

    Time frame: Baseline (Week 1), Week 5, and Week 8

    Fat mass percentage (%) assessed by multi-frequency bioelectrical impedance analysis (SECA mBCA 515).

  2. Change in Fat-Free Mass (FFM)

    Time frame: Baseline (Week 1), Week 5, and Week 8

    Fat-free mass (kg) assessed by multi-frequency bioelectrical impedance analysis (SECA mBCA 515).

  3. Change in Skeletal Muscle Mass (SMM)

    Time frame: Baseline (Week 1), Week 5, and Week 8

    Skeletal muscle mass (kg) assessed by multi-frequency bioelectrical impedance analysis (SECA mBCA 515).

  4. Change in Maximal Strength - Isometric Mid-Thigh Pull (IMTP)

    Time frame: Baseline (Week 1), Week 5, and Week 8

    Maximal force during IMTP measured using a force plate system (k-Delta). Best of two trials recorded.

  5. Change in Maximal Voluntary Isometric Contraction (MVC)

    Time frame: Baseline (Week 1), Week 5, and Week 8

    Knee extension MVC force measured using a strain gauge system. Best of trials recorded per protocol procedures.

  6. Change in Handgrip Strength

    Time frame: Baseline (Week 1), Week 5, and Week 8

    Handgrip strength measured with a handgrip dynamometer; best value recorded.

  7. Change in Countermovement Jump (CMJ) Performance

    Time frame: Baseline (Week 1), Week 5, and Week 8

    Jump height measured via force plate system; best of two trials recorded.

  8. Change in Peak Power Output (Wingate Test)

    Time frame: Baseline (Week 1), Week 5, and Week 8

    Peak power output (W) during a 30-second Wingate Anaerobic Test performed on a cycle ergometer.

  9. Change in Mean Power Output (Wingate Test)

    Time frame: Baseline (Week 1), Week 5, and Week 8

    Mean power output (W) during a 30-second Wingate Anaerobic Test performed on a cycle ergometer.

  10. Change in Urinary Titin N-terminal Fragment to Creatinine Ratio (UTF/Cr)

    Time frame: Baseline (Week 1) and Week 5

    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.

  11. Change in Serum Creatine Kinase (CK)

    Time frame: Baseline (Week 1), Week 5, and Week 8

    Serum CK concentration measured from blood samples as a marker of muscle damage.

  12. Change in Serum Urea (Blood Urea Nitrogen, BUN)

    Time frame: Baseline (Week 1), Week 5, and Week 8

    Serum urea concentration (mg/dL or mmol/L) measured from venous blood samples.

  13. Change in Total Testosterone

    Time frame: Baseline (Week 1), Week 5, and Week 8

    Serum total testosterone measured from blood samples.

  14. Change in C-Reactive Protein (CRP)

    Time frame: Baseline (Week 1), Week 5, and Week 8

    Serum C-reactive protein concentration (mg/L) measured from venous blood samples.

  15. Change in Tumor Necrosis Factor-alpha (TNF-α)

    Time frame: Baseline (Week 1), Week 5, and Week 8

    Serum TNF-α concentration (pg/mL) measured from venous blood samples.

  16. Change in Interleukin-6 (IL-6)

    Time frame: Baseline (Week 1), Week 5, and Week 8

    Serum IL-6 concentration (pg/mL) measured from venous blood samples.

  17. Change in Resting Metabolic Rate (RMR)

    Time frame: Baseline (Week 1) and Week 8

    Resting metabolic rate (kcal/day) assessed by indirect calorimetry using a metabolic cart under standardized fasting conditions.

Study contacts

Contact information is provided by the study sponsor or research team.

Lien Bruck

CONTACT

[email protected]

0587487431

Lien Bruck

CONTACT

[email protected]

0587487431

Sponsors and collaborators

Lead sponsor

Tel Aviv University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 27, 2026
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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