GG-statin: Annatto-derived GG for Statin-associated Myopathy
Study Details
Study Description
Brief Summary
To evaluate the effects of 3-months annatto-derived geranylgeraniol (GG) supplementation on statin-associated skeletal muscle health.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo Placebo group: subject will take one pill (150 mg olive oil) after breakfast and another pill (150 mg olive oil) after dinner |
Dietary Supplement: Placebo
300 mg olive oil
|
| Active Comparator: Low GG LOW GG group: subject will take one pill (150 mg olive oil) after breakfast and another pill (150 mg GG) after dinner |
Dietary Supplement: Low GG
150 mg GG
|
| Active Comparator: High GG HIGH GG group: subject will take one pill (150 mg GG) after breakfast and another pill (150 mg GG) after dinner |
Dietary Supplement: High GG
300 mg GG
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- Functional lower body strength [change in functional lower body strength at 3 months]
Functional lower body strength is measured using a loaded 50m walk.
- 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
- 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 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
- blood biomarkers: hsCRP [changes in serum hsCRP at 3 months]
hsCRP is to assess inflammation
- blood biomarker: IL-6 [changes in serum IL-6 at 3 months]
IL-6 is to assess inflammation
- 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
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Texas Tech University Health Sciences Center | Lubbock | Texas | United States | 79430 |
Sponsors and Collaborators
- Texas Tech University Health Sciences Center
Investigators
- Principal Investigator: Chwan-Li (Leslie) Shen, PhD, Texas Tech Health Science Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- L22-130