Annatto-derived GG for Statin-associated Myopathy

NCT05312424 | Recruiting Phase 1

• 1 other identifier: L22-130
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Myopathy; Primary

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Lower body isometric strength

  change in lower body isometric strength at 3 months

• Functional lower body strength

  change in functional lower body strength at 3 months

• Wall-sit test

  change in wall-sit test at 3 months

• Heel raise test

  change in heel raise test at 3 months

• blood biomarkers: serum creatinine kinase activity

  change in serum creatinine kinase activity at 3 months

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Low GG

ACTIVE COMPARATOR

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

High GG

ACTIVE COMPARATOR

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

Interventions

Placebo DIETARY_SUPPLEMENT

300 mg olive oil

Placebo

Low GG DIETARY_SUPPLEMENT

150 mg GG

Low GG

High GG DIETARY_SUPPLEMENT

300 mg GG

High GG

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead

Study Sites (1)

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

RECRUITING

MeSH Terms

Conditions

Muscular Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Chwan-Li (Leslie) Shen, PhD

  Texas Tech Health Science Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chwan-Li (Leslie) Shen, PhD

CONTACT

8067432815; leslie.shen@ttuhsc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: April 5, 2022
• Study Start: July 15, 2022
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)