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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo group: subject will take one pill (150 mg olive oil) after breakfast and another pill (150 mg olive oil) after dinner |
|
| Low GG | Active Comparator | LOW GG group: subject will take one pill (150 mg olive oil) after breakfast and another pill (150 mg GG) after dinner |
|
| High GG | Active Comparator | HIGH GG group: subject will take one pill (150 mg GG) after breakfast and another pill (150 mg GG) after dinner |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | 300 mg olive oil |
| |
| Low GG |
| Measure | Description | Time Frame |
|---|---|---|
| SAMS-CI | Statin-Associated Muscle Symptom Clinical Index (SAMS-CI) is to assess muscle pain, muscle weakness, tiredness, and cramps. | change in SAMS-CI at 3 months |
| BPI | Brief Pain Inventory (BPI) is to assess pain and interference of pain with everyday life. | change in BPI at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Lower body isometric strength | Lower body (i.e., predominantly of the quadriceps and hip extensors) isometric strength is measured using a dynamometer | change in lower body isometric strength at 3 months |
| Functional lower body strength |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chwan-Li (Leslie) Shen, PhD | Contact | 8067432815 | leslie.shen@ttuhsc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Chwan-Li (Leslie) Shen, PhD | Texas Tech Health Science Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Tech University Health Sciences Center | Recruiting | Lubbock | Texas | 79430 | United States |
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| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| Dietary Supplement |
150 mg GG |
|
| High GG | Dietary Supplement | 300 mg GG |
|
Functional lower body strength is measured using a loaded 50m walk.
| change in functional lower body strength at 3 months |
| Wall-sit test | Wall-sit test (wall-slide test) is to assess static leg strength and endurance, particularly of the quadriceps and hip extensors | change in wall-sit test at 3 months |
| Heel raise test | 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 | change in heel raise test at 3 months |
| blood biomarkers: serum creatinine kinase activity | Creatine kinase is to assess muscle damage. | change in serum creatinine kinase activity at 3 months |
| blood biomarkers: myostatin | Myostatin is to assess muscle damage | changes in serum myostatin at 3 months |
| blood biomarkers: atrogin 1 | atrogin 1 is to assess muscle damage | changes in serum atrogin 1 at 3 months |
| blood biomarkers: hsCRP | hsCRP is to assess inflammation | changes in serum hsCRP at 3 months |
| blood biomarker: IL-6 | IL-6 is to assess inflammation | changes in serum IL-6 at 3 months |
| blood lipid profiles | lipid profiles include total triglycerides, total cholesterol, HDL, and calculated LDL | changes in blood lipid profiles at 3 months |
| plasma menaquinone-4 (MK4) + menaquinone-4 (MK7) | MK4 and MK4 are vitamin K2 homologues and are measured by HPLC | changes in plasma MK4+MK7 at 3 months |