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NOT YET RECRUITING
NCT07401017
NA

The Effects of Rosuvastatin on Running Training Adaptation and Safety

Sponsor: Taipei Medical University WanFang Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-03-01

Completion Date

2026-10-31

Last Updated

2026-02-10

Healthy Volunteers

Yes

Interventions

DRUG

Rosuvastatin

Rosuvastatin 10 mg tablet taken orally once daily at bedtime for 3 months.

Locations (1)

Taipei medical university

Taipei, Taiwan