Annatto-derived GG for Statin-associated Myopathy
- Conditions
- Myopathy; Primary
- Interventions
- Dietary Supplement: Low GGDietary Supplement: PlaceboDietary Supplement: High GG
- Registration Number
- NCT05312424
- Lead Sponsor
- Texas Tech University Health Sciences Center
- 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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 95
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low GG Low GG LOW GG group: subject will take one pill (150 mg olive oil) after breakfast and another pill (150 mg GG) after dinner Placebo Placebo Placebo group: subject will take one pill (150 mg olive oil) after breakfast and another pill (150 mg olive oil) after dinner High GG High GG HIGH GG group: subject will take one pill (150 mg GG) after breakfast and another pill (150 mg GG) after dinner
- Primary Outcome Measures
Name Time Method SAMS-CI change in SAMS-CI at 3 months Statin-Associated Muscle Symptom Clinical Index (SAMS-CI) is to assess muscle pain, muscle weakness, tiredness, and cramps.
BPI change in BPI at 3 months Brief Pain Inventory (BPI) is to assess pain and interference of pain with everyday life.
- Secondary Outcome Measures
Name Time Method blood biomarkers: hsCRP changes in serum hsCRP at 3 months hsCRP is to assess inflammation
blood biomarkers: serum creatinine kinase activity change in serum creatinine kinase activity at 3 months Creatine kinase is to assess muscle damage.
blood biomarkers: myostatin changes in serum myostatin at 3 months Myostatin is to assess muscle damage
blood biomarkers: atrogin 1 changes in serum atrogin 1 at 3 months atrogin 1 is to assess muscle damage
Lower body isometric strength change in lower body isometric strength at 3 months Lower body (i.e., predominantly of the quadriceps and hip extensors) isometric strength is measured using a dynamometer
Heel raise test change in heel raise test at 3 months 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
blood biomarker: IL-6 changes in serum IL-6 at 3 months IL-6 is to assess inflammation
Functional lower body strength change in functional lower body strength at 3 months Functional lower body strength is measured using a loaded 50m walk.
blood lipid profiles changes in blood lipid profiles at 3 months lipid profiles include total triglycerides, total cholesterol, HDL, and calculated LDL
plasma menaquinone-4 (MK4) + menaquinone-4 (MK7) changes in plasma MK4+MK7 at 3 months MK4 and MK4 are vitamin K2 homologues and are measured by HPLC
Wall-sit test change in wall-sit test at 3 months Wall-sit test (wall-slide test) is to assess static leg strength and endurance, particularly of the quadriceps and hip extensors
Trial Locations
- Locations (1)
Texas Tech University Health Sciences Center
🇺🇸Lubbock, Texas, United States