Myopathy; Primary
Conditions
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.
Interventions
DIETARY_SUPPLEMENTPlacebo
300 mg olive oil
DIETARY_SUPPLEMENTLow GG
150 mg GG
DIETARY_SUPPLEMENTHigh GG
300 mg GG
Sponsors
Texas Tech University Health Sciences Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
CONTACTChwan-Li (Leslie) Shen, PhD
PRINCIPAL_INVESTIGATORChwan-Li (Leslie) Shen, PhD
Texas Tech Health Science Center
Outcome results
None listed