Status:
RECRUITING
Annatto-derived GG for Statin-associated Myopathy
Lead Sponsor:
Texas Tech University Health Sciences Center
Conditions:
Myopathy; Primary
Eligibility:
All Genders
40+ years
Phase:
PHASE1
PHASE2
Brief Summary
To evaluate the effects of 3-months annatto-derived geranylgeraniol (GG) supplementation on statin-associated skeletal muscle health.
Detailed Description
Statins are widely prescribed cholesterol-lowering oral drugs. The majority of reported adverse effects due to statin include muscle pain, weakness, cramp, and tiredness. CoQ10 supplementation has bee...
Eligibility Criteria
Inclusion
- Age ≥40 of either sex
- Statin-treated patients with muscle pain alone or accompanied by other symptoms.
- Patients currently receiving a statin who developed new-onset myalgias in within 90 day of initiation or a dosage increase
Exclusion
- Malignancy or significant neurological or psychiatric disturbances, including alcohol or drug abuse.
- Woman who is pregnant, breastfeeding, or of childbearing potential and not taking adequate contraceptive precautions.
- Had CoQ10 supplement one month before starting the study.
- Genetic musculoskeletal and neurologic disorder known to affect skeletal muscle metabolism
- Had steroid medication one month before starting the study.
Key Trial Info
Start Date :
July 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT05312424
Start Date
July 15 2022
End Date
December 31 2027
Last Update
September 12 2025
Active Locations (1)
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1
Texas Tech University Health Sciences Center
Lubbock, Texas, United States, 79430