Effects of annatto-derived GG on muscle health in statin users
Official title: Effect of Annatto-derived Geranylgeraniol (GG) on Statin-associated Myopathy
Run by Texas Tech University Health Sciences Center · NCT05312424 · Data updated 2026-11-12
This study is testing if a supplement made from annatto can help people over 40 who have muscle pain from taking statins feel better after three months.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 40 Years and up |
| Sex | All |
| Enrollment | 95 (estimated) |
| Sponsor | Texas Tech University Health Sciences Center Academic / other |
| Locations | 1 site (Lubbock, Texas) |
| Status | Recruiting |
| Started | July 15, 2022 |
| Main results expected | June 30, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | September 11, 2026 |
| Trial ID | NCT05312424 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are statin-treated patients aged 40 and older who have developed muscle pain within 90 days of starting or increasing their statin dosage.
✕Probably not a fit
Patients with significant neurological or psychiatric disorders, malignancies, or those who have recently taken CoQ10 or steroids may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the impact of 3-month supplementation with annatto-derived geranylgeraniol (GG) on muscle health in patients experiencing muscle pain due to statin use. Participants aged 40 and older, who are currently on statins and have developed muscle pain, will be randomly assigned to receive either a placebo, low dose, or high dose of GG. The study will assess muscle-related outcomes through questionnaires, performance tests, and blood samples at baseline and after 3 months, while also monitoring safety and recording lifestyle factors. The goal is to determine if GG can alleviate statin-associated myopathy symptoms.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients suffering from muscle pain related to statin therapy.
How similar studies have gone: While CoQ10 supplementation has been studied with mixed results, this approach using annatto-derived GG is novel and has not been extensively tested in this context.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Texas Tech University Health Sciences Center
Lubbock, Texas, United States Recruiting
Study contacts
- Principal investigator: Chwan-Li (Leslie) Shen, PhD — Texas Tech Health Science Center
- Study coordinator: Chwan-Li (Leslie) Shen, PhD
- Email: leslie.shen@ttuhsc.edu
- Phone: 8067432815
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.