Annatto-derived GG for Statin-associated Myopathy

Last updated: August 2, 2024
Sponsor: Texas Tech University Health Sciences Center
Overall Status: Active - Recruiting

Phase

1/2

Condition

N/A

Treatment

Low GG

High GG

Placebo

Clinical Study ID

NCT05312424
L22-130
  • Ages > 40
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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 90day of initiation or a dosage increase

Exclusion

Exclusion Criteria:

  • Malignancy or significant neurological or psychiatric disturbances, includingalcohol or drug abuse.

  • Woman who is pregnant, breastfeeding, or of childbearing potential and not takingadequate contraceptive precautions.

  • Had CoQ10 supplement one month before starting the study.

  • Genetic musculoskeletal and neurologic disorder known to affect skeletal musclemetabolism

  • Had steroid medication one month before starting the study.

Study Design

Total Participants: 95
Treatment Group(s): 3
Primary Treatment: Low GG
Phase: 1/2
Study Start date:
July 15, 2022
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Texas Tech University Health Sciences Center

    Lubbock, Texas 79430
    United States

    Active - Recruiting

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