Creatine Supplementation and Resistance Training to Improve Sarcopenia Parameters in Patients With Prostate Cancer After Androgen Deprivation Therapy

Sponsor
University of Sao Paulo
Study ID
NCT07463092
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Creatine Monohydrate — DIETARY_SUPPLEMENT
    Participants will receive 5 g/day of creatine monohydrate throughout the 12-week supervised resistance training program.
  • Maltodextrin — DIETARY_SUPPLEMENT
    Participants will receive 5 g/day of maltodextrin, matched in appearance and caloric content to creatine, throughout the 12-week supervised resistance training program.
  • Resistance training — BEHAVIORAL
    Participants will complete a 12-week supervised, progressive resistance training program designed to improve muscle strength and muscle mass. Training sessions will be conducted under professional supervision and will occur three times per week. The program will target major muscle groups of the upper and lower body using weight machines and free weights. All participants in both study arms will follow the same resistance training protocol.

Study Details

This randomized, double-blind, placebo-controlled clinical trial will investigate the effects of creatine supplementation combined with a 12-week supervised resistance training program on muscle mass, muscle strength, physical performance (e.g., parameters of sarcopenia), and muscle density in men with prostate cancer undergoing androgen deprivation therapy (ADT). ADT often causes loss of lean mass, reduced muscle strength, functional impairment, and increased fat mass. Eligible male patients will be randomly assigned to receive either creatine monohydrate or a placebo (maltodextrin) in a double-blind manner, in addition to participating in the resistance exercise program. Assessments will be performed at baseline and after the 12-week intervention period and will include: * Muscle density and architecture assessed by ultrasound * Body composition (lean mass and fat mass) * Muscle strength * Physical performance (functional performance tests) * Inflammatory biomarkers * Vascular function parameters The primary goal is to assess whether creatine supplementation combined with resistance training can safely improve muscle quality and quantity, strength, and physical function in these patients. If effective and safe, the intervention could help reduce muscle loss and improve quality of life in men undergoing ADT.

Key Dates

First listed
Mar 10, 2026
Start date
May 1, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2028
Completion
Jan 31, 2029

Study Design

Enrollment
34 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Creatine Supplementation + Resistance Training
    Participants assigned to the experimental arm will complete a 12-week supervised, progressive resistance training program and receive 5 g/day of creatine monohydrate. Creatine supplementation will be administered daily throughout the intervention period.
  • Active Comparator: Placebo (Maltodextrin) + Resistance Training
    Participants assigned to the control arm will complete a 12-week supervised, progressive resistance training program and receive 5 g/day of maltodextrin. Maltodextrin will be administered daily throughout the intervention period.

Primary Outcome Measure

Muscle Density (Ultrasound-derived Echo Intensity and Thickness) [ Time Frame: Baseline and 12 weeks. ]

Central Contacts

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