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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Placebo
Dietary supplement300 mg olive oil
Low GG
Dietary supplement150 mg GG
High GG
Dietary supplement300 mg GG
Treatment groups
95 Participants
are divided into 3 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: Low GGActive comparator 1 intervention
Group C: High GGActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
SAMS-CI
Statin-Associated Muscle Symptom Clinical Index (SAMS-CI) is to assess muscle pain, muscle weakness, tiredness, and cramps.
Time frame
change in SAMS-CI at 3 months2
BPI
Brief Pain Inventory (BPI) is to assess pain and interference of pain with everyday life.
Time frame
change in BPI at 3 monthsSecondary outcomes
1
Lower body isometric strength
Lower body (i.e., predominantly of the quadriceps and hip extensors) isometric strength is measured using a dynamometer
Time frame
change in lower body isometric strength at 3 months2
Functional lower body strength
Functional lower body strength is measured using a loaded 50m walk.
Time frame
change in functional lower body strength at 3 months3
Wall-sit test
Wall-sit test (wall-slide test) is to assess static leg strength and endurance, particularly of the quadriceps and hip extensors
Time frame
change in wall-sit test at 3 months4
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
Time frame
change in heel raise test at 3 monthsSponsors and contacts
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Source ClinicalTrials.gov