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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
L-leucine supplementation
Dietary supplementParticipants 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
BehavioralIso-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)
BehavioralIso-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
Trial outcomes
Primary outcomes
Change in Lean Body Mass (LBM)
Lean body mass (kg) assessed by multi-frequency bioelectrical impedance analysis (BIA) using the SECA mBCA 515.
Secondary outcomes
Change in Fat Mass Percentage
Fat mass percentage (%) assessed by multi-frequency bioelectrical impedance analysis (SECA mBCA 515).
Change in Fat-Free Mass (FFM)
Fat-free mass (kg) assessed by multi-frequency bioelectrical impedance analysis (SECA mBCA 515).
Change in Skeletal Muscle Mass (SMM)
Skeletal muscle mass (kg) assessed by multi-frequency bioelectrical impedance analysis (SECA mBCA 515).
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.
Locations
Sponsors and contacts
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