Annatto-derived GG for Statin-associated Myopathy (GG-statin)

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

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

Study Overview

• Status: Recruiting
• Conditions: Myopathy; Primary
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Low GG; Dietary supplement: High GG

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.

• Study Type: Interventional
• Enrollment (Estimated): 95
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Chwan-Li (Leslie) Shen, PhD; Phone Number: 8067432815; Email: leslie.shen@ttuhsc.edu

Study Locations

• United States
  • Texas
    • Lubbock, Texas, United States, 79430
      • Recruiting
      • Texas Tech University Health Sciences Center
      • Contact: Chwan-Li (Leslie) Shen, PhD; Phone Number: 806-743-2815; Email: leslie.shen@ttuhsc.edu
      • Principal Investigator: Chwan-Li (Leslie) Shen, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo group: subject will take one pill (150 mg olive oil) after breakfast and another pill (150 mg olive oil) after dinner	Dietary supplement: Placebo; 300 mg olive oil
Active Comparator: Low GG; LOW GG group: subject will take one pill (150 mg olive oil) after breakfast and another pill (150 mg GG) after dinner	Dietary supplement: Low GG; 150 mg GG
Active Comparator: High GG; HIGH GG group: subject will take one pill (150 mg GG) after breakfast and another pill (150 mg GG) after dinner	Dietary supplement: High GG; 300 mg GG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SAMS-CI	Statin-Associated Muscle Symptom Clinical Index (SAMS-CI) is to assess muscle pain, muscle weakness, tiredness, and cramps.	change in SAMS-CI at 3 months
BPI	Brief Pain Inventory (BPI) is to assess pain and interference of pain with everyday life.	change in BPI at 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lower body isometric strength	Lower body (i.e., predominantly of the quadriceps and hip extensors) isometric strength is measured using a dynamometer	change in lower body isometric strength at 3 months
Functional lower body strength	Functional lower body strength is measured using a loaded 50m walk.	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	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	change in heel raise test at 3 months
blood biomarkers: serum creatinine kinase activity	Creatine kinase is to assess muscle damage.	change in serum creatinine kinase activity at 3 months
blood biomarkers: myostatin	Myostatin is to assess muscle damage	changes in serum myostatin at 3 months
blood biomarkers: atrogin 1	atrogin 1 is to assess muscle damage	changes in serum atrogin 1 at 3 months
blood biomarkers: hsCRP	hsCRP is to assess inflammation	changes in serum hsCRP at 3 months
blood biomarker: IL-6	IL-6 is to assess inflammation	changes in serum IL-6 at 3 months
blood lipid profiles	lipid profiles include total triglycerides, total cholesterol, HDL, and calculated LDL	changes in blood lipid profiles at 3 months
plasma menaquinone-4 (MK4) + menaquinone-4 (MK7)	MK4 and MK4 are vitamin K2 homologues and are measured by HPLC	changes in plasma MK4+MK7 at 3 months

Collaborators and Investigators

• Sponsor: Texas Tech University Health Sciences Center
• Investigators: Principal Investigator: Chwan-Li (Leslie) Shen, PhD, Texas Tech Health Science Center

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2022
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: March 9, 2022
• First Submitted That Met QC Criteria: April 1, 2022
• First Posted (Actual): April 5, 2022

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 5, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nervous System Diseases; Neuromuscular Diseases; Muscular Diseases; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: L22-130

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No