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

Texas Tech University Health Sciences Center

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Myopathy; Primary

Treatments: Dietary Supplement: Low GG; Dietary Supplement: High GG; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05312424

L22-130

Details and patient eligibility

About

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

Full 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.

Enrollment: 95 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

95 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo

Low GG

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Low GG

High GG

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: High GG