Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 5:41 AM
Study NCT ID:
NCT07438158
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-02
First Post:
2026-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Protein Distribution and Leucine Supplementation Effects on Body Composition and Performance in Tactical Athletes
Sponsor:
Tel Aviv University
Organization:
Study Overview
Official 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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
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:
1. EVEN: Protein evenly distributed across three daily meals (08:00, 13:00, 18:00).
2. 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.
3. 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.
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:
1. EVEN: Protein evenly distributed across three daily meals (08:00, 13:00, 18:00).
2. 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.
3. 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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: