Clinical trial NCT05312424: Annatto-derived GG for Statin-associated Myopathy
Official title: Effect of Annatto-derived Geranylgeraniol (GG) on Statin-associated Myopathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Myopathy; Primary
Lead sponsor: Texas Tech University Health Sciences Center
Sponsor class: OTHER
First posted: 2022-04-05
Enrollment: 95
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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: 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.

Primary outcomes:
measure: SAMS-CI
timeFrame: change in SAMS-CI at 3 months
measure: BPI
timeFrame: change in BPI at 3 months
Secondary outcomes:
measure: Lower body isometric strength
timeFrame: change in lower body isometric strength at 3 months
measure: Functional lower body strength
timeFrame: change in functional lower body strength at 3 months
measure: Wall-sit test
timeFrame: change in wall-sit test at 3 months
measure: Heel raise test
timeFrame: change in heel raise test at 3 months
measure: blood biomarkers: serum creatinine kinase activity
timeFrame: change in serum creatinine kinase activity at 3 months
measure: blood biomarkers: myostatin
timeFrame: changes in serum myostatin at 3 months
measure: blood biomarkers: atrogin 1
timeFrame: changes in serum atrogin 1 at 3 months
measure: blood biomarkers: hsCRP
timeFrame: changes in serum hsCRP at 3 months
measure: blood biomarker: IL-6
timeFrame: changes in serum IL-6 at 3 months
measure: blood lipid profiles
timeFrame: changes in blood lipid profiles at 3 months
measure: plasma menaquinone-4 (MK4) + menaquinone-4 (MK7)
timeFrame: changes in plasma MK4+MK7 at 3 months
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
Study officials:
affiliation: Texas Tech Health Science Center
name: Chwan-Li (Leslie) Shen, PhD
role: PRINCIPAL_INVESTIGATOR
References: