Recruiting
Phase 1
Phase 2

GG

Sponsor:

Texas Tech University Health Sciences Center

Code:

NCT05312424

Conditions

Myopathy; Primary

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Accepted

Interventions

Placebo

Low GG

High GG

Study Details

Brief summary:

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

Conditions

Myopathy; Primary

Study ID

NCT05312424

Start date

Jul 15, 2022

Status verified date

Sep, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Accepted

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 Design

Enrollment

95 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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

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

Interventions

Placebo

300 mg olive oil

Low GG

150 mg GG

High GG

300 mg GG

Primary outcome measure

  • SAMS-CI [ Time Frame: change in SAMS-CI at 3 months ]
  • BPI [ Time Frame: change in BPI at 3 months ]

Central Contacts and Locations

Central contacts

Chwan-Li (Leslie) Shen, PhD

8067432815leslie.shen@ttuhsc.edu

Locations

Texas Tech University Health Sciences Center

Recruiting

Lubbock, Texas, United States, 79430

Contacts

Chwan-Li (Leslie) Shen, PhD

806-743-2815Leslie.Shen@ttuhsc.edu

Principal Investigator:

Chwan-Li (Leslie) Shen, PhD

More Information

Sponsor

Texas Tech University Health Sciences Center

Last update posted

Sep 11, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Texas Tech University Health Sciences Center on 2026-09-11. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.