NCT07401017

The Effects of Rosuvastatin on Running Training Adaptation and Safety

The Effects of Rosuvastatin on Physiological Adaptation and Safety During Regular Long-Distance Running Training: A Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Taipei Medical University WanFang Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Statins lower low-density lipoprotein cholesterol (LDL-C) and help prevent atherosclerotic cardiovascular disease, but some users develop statin-associated muscle symptoms (SAMS) such as soreness, stiffness, weakness, or elevated creatine kinase (CK). These symptoms may be more noticeable during exercise. Regular long-distance running improves cardiopulmonary fitness-VO₂max, aerobic threshold (AT), and respiratory compensation point (RCP)-mainly through mitochondrial and metabolic adaptations. Prior studies suggest that lipophilic statins like simvastatin may blunt these adaptations, while hydrophilic statins such as rosuvastatin may have a smaller impact. However, prospective data in habitual endurance runners are limited. This randomized controlled trial will examine how rosuvastatin affects cardiopulmonary fitness improvements and muscle tolerance in individuals who run at least three times per week and meet clinical criteria for statin therapy. After informed consent and baseline cardiopulmonary exercise testing (CPET), participants will be randomized to rosuvastatin 10 mg daily or no statin therapy for three months. Both groups will maintain their usual training routines, and training load will be recorded using heart-rate-based TRIMP. CPET will be repeated monthly to assess changes in VO₂max, AT, and RCP, and muscle enzymes and SAMS will be evaluated at each visit. The study aims to clarify whether rosuvastatin influences endurance-related physiological adaptations or increases muscle symptoms in regular long-distance runners.

Conditions

• Dyslipidemia
• Long-Distance Running
• Endurance Training
• Statin-Associated Muscle Symptoms

Interventions

Type	Name	Description
DRUG	Rosuvastatin	Rosuvastatin 10 mg tablet taken orally once daily at bedtime for 3 months.

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-08-31
• Completion: 2026-10-31
• First posted: 2026-02-10
• Last updated: 2026-02-10

Locations

1 site across 1 country: Taiwan