NCT05312424PHASE1, PHASE2RecruitingAccepts Healthy Volunteers

Annatto-derived GG for Statin-associated Myopathy

Texas Tech University Health Sciences Center

Start Date

7/15/2022

Completion Date

12/31/2027

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.

Eligibility Criteria

Age Range: 40 years to No maximum

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.

Interventions

DIETARY_SUPPLEMENT

Placebo

DIETARY_SUPPLEMENT

Low GG

DIETARY_SUPPLEMENT

High GG

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Conditions

Myopathy; Primary

Locations

Texas Tech University Health Sciences Center

Lubbock, Texas 79430

United States