RecruitingPhase 1Phase 2NCT05312424
Annatto-derived GG for Statin-associated Myopathy
Effect of Annatto-derived Geranylgeraniol (GG) on Statin-associated Myopathy
Sponsor
Texas Tech University Health Sciences Center
Enrollment
95 participants
Start Date
Jul 15, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
To evaluate the effects of 3-months annatto-derived geranylgeraniol (GG) supplementation on statin-associated skeletal muscle health.
Eligibility
Min Age: 40 Years
Plain Language Summary
Simplified for easier understanding
This study tests whether annatto-derived GG (a form of vitamin K2) can reduce muscle pain caused by statin medications - a common side effect known as statin-associated myopathy. Statins are widely prescribed cholesterol-lowering drugs, but up to 10-15% of people develop muscle pain. This study tests a natural supplement as a potential solution.
You may be eligible if:
- You are 40 or older
- You are currently taking a statin medication
- You developed new muscle pain within 90 days of starting or increasing your statin dose
You may NOT be eligible if:
- You have cancer, a significant neurological disorder, or a history of alcohol or drug abuse
- You are pregnant, breastfeeding, or of childbearing age without adequate contraception
- You have taken CoQ10 supplements in the past month
- You have a genetic musculoskeletal or neurological condition affecting muscle metabolism
- You have taken steroids in the past month
Talk to your doctor to see if this trial is right for you.
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
DIETARY_SUPPLEMENTPlacebo
300 mg olive oil
DIETARY_SUPPLEMENTLow GG
150 mg GG
DIETARY_SUPPLEMENTHigh GG
300 mg GG
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05312424