NCT05312424

Annatto-derived GG for Statin-associated Myopathy

Effect of Annatto-derived Geranylgeraniol (GG) on Statin-associated Myopathy

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 95 (estimated)
• Sponsor: Texas Tech University Health Sciences Center · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Myopathy; Primary

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Placebo	300 mg olive oil
DIETARY_SUPPLEMENT	Low GG	150 mg GG
DIETARY_SUPPLEMENT	High GG	300 mg GG

Timeline

• Start date: 2022-07-15
• Primary completion: 2027-06-30
• Completion: 2027-12-31
• First posted: 2022-04-05
• Last updated: 2025-09-12

Locations

1 site across 1 country: United States