Annatto-derived GG for Statin-associated Myopathy

Phase 2RecruitingNCT05312424

Texas Tech University Health Sciences Center95 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Myopathy; Primary

Interventions

PlaceboDIETARY_SUPPLEMENT

300 mg olive oil

Low GGDIETARY_SUPPLEMENT

150 mg GG

High GGDIETARY_SUPPLEMENT

300 mg GG

Eligibility

Sex: ALLMin age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Texas Tech University Health Sciences Center

Lubbock, Texas, United States

RECRUITING

Outcomes

Primary Outcomes

SAMS-CI

Statin-Associated Muscle Symptom Clinical Index (SAMS-CI) is to assess muscle pain, muscle weakness, tiredness, and cramps.

Time frame: change in SAMS-CI at 3 months

BPI

Brief Pain Inventory (BPI) is to assess pain and interference of pain with everyday life.

Time frame: change in BPI at 3 months

Secondary Outcomes

Lower body isometric strength

Lower body (i.e., predominantly of the quadriceps and hip extensors) isometric strength is measured using a dynamometer

Time frame: change in lower body isometric strength at 3 months

Functional lower body strength

Functional lower body strength is measured using a loaded 50m walk.

Time frame: change in functional lower body strength at 3 months

Wall-sit test

Wall-sit test (wall-slide test) is to assess static leg strength and endurance, particularly of the quadriceps and hip extensors

Time frame: change in wall-sit test at 3 months

Heel raise test

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

Time frame: change in heel raise test at 3 months

blood biomarkers: serum creatinine kinase activity

Creatine kinase is to assess muscle damage.

Time frame: change in serum creatinine kinase activity at 3 months

Central Contacts

Chwan-Li (Leslie) Shen, PhD

CONTACT

8067432815 leslie.shen@ttuhsc.edu

Data from ClinicalTrials.gov

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