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

ConditionMuscle Damage
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-35
SponsorTel Aviv University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

69 Participants
are divided into 3 treatment groups
Group A: EVEN (Even Protein Distribution)Other 1 intervention
Group B: FAST (Protein-Fasting Morning; Protein at Lunch + Dinner)Experimental treatment 1 intervention
Group C: FAST-RESCUE (FAST + Leucine at Breakfast)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Lean Body Mass (LBM)

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

Time frame
Baseline (Week 1) to Week 8

Secondary outcomes

1

Change in Fat Mass Percentage

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

Time frame
Baseline (Week 1), Week 5, and Week 8
2

Change in Fat-Free Mass (FFM)

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

Time frame
Baseline (Week 1), Week 5, and Week 8
3

Change in Skeletal Muscle Mass (SMM)

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

Time frame
Baseline (Week 1), Week 5, and Week 8
4

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.

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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