Annatto-derived GG for Statin-associated Myopathy
ConditionMyopathy; Primary
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age40+
SponsorTexas Tech University Health Sciences Center
About this trial
To evaluate the effects of 3-months annatto-derived geranylgeraniol (GG) supplementation on statin-associated skeletal muscle health.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Placebo
- Low GG
- High GG
Treatment groups
95 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov