DyslipidemiaNCT07401017
The Effects of Rosuvastatin on Running Training Adaptation and Safety
A study testing Rosuvastatin in people with Dyslipidemia and Long-Distance Running, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemia, Long-Distance Running, Endurance Training
- What is being tested?
- Rosuvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2026to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Meets clinical criteria for statin therapy, including at least one of the following:
- Family history of hyperlipidemia.
- LDL-C ≥ 160 mg/dL.
- 10-year Atherosclerotic Cardiovascular Disease (ASCVD) risk ≥ 7.5%
- Diabetes mellitus with LDL-C ≥ 70 mg/dL.
Show all 11Show fewer
- Determined by a clinician to require lipid-lowering therapy.
- Currently using or eligible to initiate rosuvastatin therapy.
- Performs long-distance running at least 3 times per week and is willing to maintain regular training for 3 months.
- Able and willing to undergo cardiopulmonary exercise testing (CPET) and to record training data using a sports watch (for TRIMP calculation).
- No known drug allergies and provides written informed consent after study explanation.
Who cannot join
- Known allergy or intolerance to statins or rosuvastatin.
- History of severe statin-related adverse events, including rhabdomyolysis or marked creatine kinase (CK) elevation.
- Liver dysfunction with AST or ALT > 3× upper limit of normal.
- Moderate to severe renal impairment (eGFR < 30 mL/min/1.73 m²).
- Current lower-limb pain, tendon injury, or other conditions that prevent running training.
- Not suitable for maximal cardiopulmonary exercise testing (CPET), such as unstable angina, uncontrolled hypertension, or recent cardiovascular events.
- Pregnant or breastfeeding.
- Inability to comply with study procedures, including use of a sports watch, regular follow-up visits, or maintaining running training.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effects of Rosuvastatin on Physiological Adaptation and Safety During Regular Long-Distance Running Training: A Randomized Controlled Trial
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
- Being tested
- Rosuvastatin
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Rosuvastatin 10 mg tablet taken orally once daily at bedtime for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin group | Experimental | Not described Receives: Drug: Rosuvastatin |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO₂max (mL/kg/min)
Maximum oxygen consumption obtained from cardiopulmonary exercise testing (CPET). Used to assess changes in cardiopulmonary fitness over the 3-month intervention period.
Measured: Baseline (Month 0), Month 1, Month 2, Month 3
Aerobic Threshold (AT)
Aerobic threshold determined by standardized CPET. Represents the transition from aerobic to anaerobic metabolism during exercise.
Measured: Baseline, Month 1, Month 2, Month 3
Respiratory Compensation Point (RCP)
RCP measured via CPET, representing the ventilatory response to metabolic acidosis. Used to evaluate endurance training adaptation.
Measured: Baseline, Month 1, Month 2, Month 3
Secondary outcomes (4)
Calculated Training Load Score (using TRIMP method)
Training load is reported as a single Training Impulse (TRIMP) score. It is calculated by multiplying exercise duration (minutes) by a heart-rate-based intensity factor (e.g., fractional heart rate reserve). This integrates two metrics into one unified numerical value.
The formula is: TRIMP = Duration (min) x [ΔHR ratio] x y
Where:
ΔHR ratio = (HR_ex - HR_rest) / (HR_max - HR_rest) y = A weighting factor derived from an exponential function to account for the disproportionate increase in physiological strain at higher exercise intensities (using gender-specific constants: 0.64e^(1.92x) for males and 0.86e^(1.67x) for females).
Measured: Through the end of the 3-month intervention period
Number of Participants with Statin-Associated Muscle Symptoms (SAMS)
Number of participants reporting any muscle soreness, weakness, or stiffness as assessed by the SAMS questionnaire.
Measured: Month 1, Month 2, and Month 3
Change from Baseline in Body Weight (kg)
Body weight measured in kilograms (kg) to evaluate changes during the training and intervention period.
Measured: Baseline, Month 1, Month 2, Month 3
Change from Baseline in Body Mass Index (kg/m^2)
Body Mass Index (BMI) calculated as weight in kilograms divided by height in meters squared (kg/m^2).
Measured: Baseline, Month 1, Month 2, Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Hsuan Cheng, MD, MS, Study chair, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07401017
- Sponsor's protocol ID
- N2025102501
- Status last verified
- Nov 2025
- First submitted
- 1 Dec 2025
- Last updated
- 10 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sigrist C, Murner-Lavanchy I, Peschel SKV, Schmidt SJ, Kaess M, Koenig J. Early life maltreatment and resting-state heart rate variability: A systematic review and meta-analysis. Neurosci Biobehav Rev. 2021 Jan;120:307-334. doi: 10.1016/j.neubiorev.2020.10.026. Epub 2020 Nov 7.
PubMed 33171141Glei M, Schlormann W. Analysis of DNA damage and repair by comet fluorescence in situ hybridization (Comet-FISH). Methods Mol Biol. 2014;1094:39-48. doi: 10.1007/978-1-62703-706-8_4.
PubMed 24162978Yamada Y, Hoyano M, Akashi R, Oto K, Kanemitsu Y. Impact of Chemical Doping on Optical Responses in Bismuth-Doped CH3NH3PbBr3 Single Crystals: Carrier Lifetime and Photon Recycling. J Phys Chem Lett. 2017 Dec 7;8(23):5798-5803. doi: 10.1021/acs.jpclett.7b02508. Epub 2017 Nov 15.
PubMed 29130309Najmeddin F, Khalili H. Comment on: Guidelines for the diagnosis and antibiotic treatment of endocarditis in adults: a report of the Working Party of the British Society for Antimicrobial Chemotherapy. J Antimicrob Chemother. 2012 Dec;67(12):3016-7; author reply 3017. doi: 10.1093/jac/dks290. Epub 2012 Jul 24. No abstract available.
PubMed 22833643Tabit CE, Shenouda SM, Holbrook M, Fetterman JL, Kiani S, Frame AA, Kluge MA, Held A, Dohadwala MM, Gokce N, Farb MG, Rosenzweig J, Ruderman N, Vita JA, Hamburg NM. Protein kinase C-beta contributes to impaired endothelial insulin signaling in humans with diabetes mellitus. Circulation. 2013 Jan 1;127(1):86-95. doi: 10.1161/CIRCULATIONAHA.112.127514. Epub 2012 Nov 30.
PubMed 23204109Park JS, Park D. Effect of Polydeoxyribonucleotide Injection in a Patient With Carpal Tunnel Syndrome. Am J Phys Med Rehabil. 2018 Oct;97(10):e93-e95. doi: 10.1097/PHM.0000000000000901.
PubMed 29373371Hartiala O, Magnussen CG, Kajander S, Knuuti J, Ukkonen H, Saraste A, Rinta-Kiikka I, Kainulainen S, Kahonen M, Hutri-Kahonen N, Laitinen T, Lehtimaki T, Viikari JS, Hartiala J, Juonala M, Raitakari OT. Adolescence risk factors are predictive of coronary artery calcification at middle age: the cardiovascular risk in young Finns study. J Am Coll Cardiol. 2012 Oct 9;60(15):1364-70. doi: 10.1016/j.jacc.2012.05.045. Epub 2012 Sep 12.
PubMed 22981553Mikus CR, Boyle LJ, Borengasser SJ, Oberlin DJ, Naples SP, Fletcher J, Meers GM, Ruebel M, Laughlin MH, Dellsperger KC, Fadel PJ, Thyfault JP. Simvastatin impairs exercise training adaptations. J Am Coll Cardiol. 2013 Aug 20;62(8):709-14. doi: 10.1016/j.jacc.2013.02.074. Epub 2013 Apr 10.
PubMed 23583255
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Rosuvastatin on Physiological Adaptation and Safety During Regular Long-Distance Running Training: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07401017
- Acronym / sponsor ID
- N2025102501
- Conditions
- Dyslipidemia, Long-Distance Running, Endurance Training, Statin-Associated Muscle Symptoms
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin group | Experimental | Drug: Rosuvastatin |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 18 years.
- Meets clinical criteria for statin therapy, including at least one of the following:
- Family history of hyperlipidemia.
- LDL-C ≥ 160 mg/dL.
- 10-year Atherosclerotic Cardiovascular Disease (ASCVD) risk ≥ 7.5%
Key exclusion criteria (8 listed)
- Known allergy or intolerance to statins or rosuvastatin.
- History of severe statin-related adverse events, including rhabdomyolysis or marked creatine kinase (CK) elevation.
- Liver dysfunction with AST or ALT > 3× upper limit of normal.
- Moderate to severe renal impairment (eGFR < 30 mL/min/1.73 m²).
- Current lower-limb pain, tendon injury, or other conditions that prevent running training.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RosuvastatinRosuvastatin 10 mg tablet taken orally once daily at bedtime for 3 months. | Drug | Rosuvastatin group |
Primary outcome
VO₂max (mL/kg/min)
Time frame: Baseline (Month 0), Month 1, Month 2, Month 3
Maximum oxygen consumption obtained from cardiopulmonary exercise testing (CPET). Used to assess changes in cardiopulmonary fitness over the 3-month intervention period.
Aerobic Threshold (AT)
Time frame: Baseline, Month 1, Month 2, Month 3
Aerobic threshold determined by standardized CPET. Represents the transition from aerobic to anaerobic metabolism during exercise.
Respiratory Compensation Point (RCP)
Time frame: Baseline, Month 1, Month 2, Month 3
RCP measured via CPET, representing the ventilatory response to metabolic acidosis. Used to evaluate endurance training adaptation.
4 secondary outcomes
Calculated Training Load Score (using TRIMP method)
Time frame: Through the end of the 3-month intervention period
Number of Participants with Statin-Associated Muscle Symptoms (SAMS)
Time frame: Month 1, Month 2, and Month 3
Change from Baseline in Body Weight (kg)
Time frame: Baseline, Month 1, Month 2, Month 3
Change from Baseline in Body Mass Index (kg/m^2)
Time frame: Baseline, Month 1, Month 2, Month 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Background: PubMed 33171141Sigrist C, Murner-Lavanchy I, Peschel SKV, Schmidt SJ, Kaess M, Koenig J. Early life maltreatment and resting-state heart rate variability: A systematic review and meta-analysis. Neurosci Biobehav Rev. 2021 Jan;120:307-334. doi: 10.1016/j.neubiorev.2020.10.026. Epub 2020 Nov 7.
- Background: PubMed 24162978Glei M, Schlormann W. Analysis of DNA damage and repair by comet fluorescence in situ hybridization (Comet-FISH). Methods Mol Biol. 2014;1094:39-48. doi: 10.1007/978-1-62703-706-8_4.
- Background: PubMed 29130309Yamada Y, Hoyano M, Akashi R, Oto K, Kanemitsu Y. Impact of Chemical Doping on Optical Responses in Bismuth-Doped CH3NH3PbBr3 Single Crystals: Carrier Lifetime and Photon Recycling. J Phys Chem Lett. 2017 Dec 7;8(23):5798-5803. doi: 10.1021/acs.jpclett.7b02508. Epub 2017 Nov 15.
- Background: PubMed 22833643Najmeddin F, Khalili H. Comment on: Guidelines for the diagnosis and antibiotic treatment of endocarditis in adults: a report of the Working Party of the British Society for Antimicrobial Chemotherapy. J Antimicrob Chemother. 2012 Dec;67(12):3016-7; author reply 3017. doi: 10.1093/jac/dks290. Epub 2012 Jul 24. No abstract available.
- Background: PubMed 23204109Tabit CE, Shenouda SM, Holbrook M, Fetterman JL, Kiani S, Frame AA, Kluge MA, Held A, Dohadwala MM, Gokce N, Farb MG, Rosenzweig J, Ruderman N, Vita JA, Hamburg NM. Protein kinase C-beta contributes to impaired endothelial insulin signaling in humans with diabetes mellitus. Circulation. 2013 Jan 1;127(1):86-95. doi: 10.1161/CIRCULATIONAHA.112.127514. Epub 2012 Nov 30.
- Background: PubMed 29373371Park JS, Park D. Effect of Polydeoxyribonucleotide Injection in a Patient With Carpal Tunnel Syndrome. Am J Phys Med Rehabil. 2018 Oct;97(10):e93-e95. doi: 10.1097/PHM.0000000000000901.
- Background: PubMed 22981553Hartiala O, Magnussen CG, Kajander S, Knuuti J, Ukkonen H, Saraste A, Rinta-Kiikka I, Kainulainen S, Kahonen M, Hutri-Kahonen N, Laitinen T, Lehtimaki T, Viikari JS, Hartiala J, Juonala M, Raitakari OT. Adolescence risk factors are predictive of coronary artery calcification at middle age: the cardiovascular risk in young Finns study. J Am Coll Cardiol. 2012 Oct 9;60(15):1364-70. doi: 10.1016/j.jacc.2012.05.045. Epub 2012 Sep 12.
- Background: PubMed 23583255Mikus CR, Boyle LJ, Borengasser SJ, Oberlin DJ, Naples SP, Fletcher J, Meers GM, Ruebel M, Laughlin MH, Dellsperger KC, Fadel PJ, Thyfault JP. Simvastatin impairs exercise training adaptations. J Am Coll Cardiol. 2013 Aug 20;62(8):709-14. doi: 10.1016/j.jacc.2013.02.074. Epub 2013 Apr 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yu-Hsuan Cheng, MD, MS study chair
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rosuvastatin in people with Dyslipidemia and Long-Distance Running, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu-Hsuan Cheng, MD, MS (886-2-2930-7930 Ext. 1600, heathcyh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO₂max (mL/kg/min) (time frame: Baseline (Month 0), Month 1, Month 2, Month 3). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07401017, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.