Annatto-derived GG for Statin-associated Myopathy (GG-statin)

To evaluate the effects of 3-months annatto-derived geranylgeraniol (GG) supplementation on statin-associated skeletal muscle health.

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 been widely used to reduce statin-related muscle complaints. Several human studies have been reported with inconsistent effects of CoQ10 on statin-related symptoms. This study is to investigate the role of 3-month annatto-derived geranylgeraniol (GG) in statin-related muscle outcomes in humans. Qualified subjects will be matched by age, gender, and body weight, and then randomly assigned to a no GG group, a low GG dose group, or a high GG dose group. The outcome measures will be assessed at baseline and after 3 months. Muscle-associated measurements will be recorded using subject questionnaires (also follow-up after 3 and 6 months), muscle performance results, and blood samples. We will monitor the safety of subjects after 3 months. Food intake, physical activity, and medication changes will be recorded at baseline and after 3 months. All data will be analyzed statistically.

Placebo group: subject will take one pill (150 mg olive oil) after breakfast and another pill (150 mg olive oil) after dinner

LOW GG group: subject will take one pill (150 mg olive oil) after breakfast and another pill (150 mg GG) after dinner

HIGH GG group: subject will take one pill (150 mg GG) after breakfast and another pill (150 mg GG) after dinner

Statin-Associated Muscle Symptom Clinical Index (SAMS-CI) is to assess muscle pain, muscle weakness, tiredness, and cramps.

Lower body (i.e., predominantly of the quadriceps and hip extensors) isometric strength is measured using a dynamometer

Wall-sit test (wall-slide test) is to assess static leg strength and endurance, particularly of the quadriceps and hip extensors

Heel raise test is commonly used to test calf muscle endurance, function, and performance. Single-leg or both-leg raise will be tested while staining on a step bench

Inclusion Criteria: 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 Criteria: 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.