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)

Texas Tech University Health Sciences Center

Lubbock, Texas, United States

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NCT05312424