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

NCT07438158 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2026-03-02

No results posted yet for this study

Summary

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.

Conditions

  • Muscle Damage

Interventions

DIETARY_SUPPLEMENT

L-leucine supplementation

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.

BEHAVIORAL

Even Protein Distribution

Iso-caloric diet providing 1.6 g/kg/day protein evenly distributed across three daily meals for 8 weeks.

BEHAVIORAL

Skewed Protein Distribution (16-hour Protein-Fasting Window)

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.

Sponsors & Collaborators

  • Tel Aviv University

    lead OTHER

Principal Investigators

  • Yftach Gepner, PhD · Tel Aviv University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2028-12-31
Completion
2028-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07438158 on ClinicalTrials.gov