[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100463263":3},{"organization":4,"outcomesModule":7,"designInfo":63,"detailedDescription":73,"studyPopulation":62,"armGroups":74,"interventions":92,"overallOfficials":103,"centralContacts":108,"locations":113,"responsibleParty":132,"collaborators":62,"id":134,"slug":62,"hasResults":135,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":141,"sex":142,"minAge":143,"maxAge":62,"enrollmentInfo":144,"targetDuration":62,"studyType":147,"phases":148,"briefSummary":151,"conditions":152,"keywords":62,"overallStatus":115,"whyStopped":62,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},{"fullName":5,"class":6},"Texas Tech University Health Sciences Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":62},[9,13],{"measure":10,"description":11,"timeFrame":12},"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",{"measure":14,"description":15,"timeFrame":16},"BPI","Brief Pain Inventory (BPI) is to assess pain and interference of pain with everyday life.","change in BPI at 3 months",[18,22,26,30,34,38,42,46,50,54,58],{"measure":19,"description":20,"timeFrame":21},"Lower body isometric strength","Lower body (i.e., predominantly of the quadriceps and hip extensors) isometric strength is measured using a dynamometer","change in lower body isometric strength at 3 months",{"measure":23,"description":24,"timeFrame":25},"Functional lower body strength","Functional lower body strength is measured using a loaded 50m walk.","change in functional lower body strength at 3 months",{"measure":27,"description":28,"timeFrame":29},"Wall-sit test","Wall-sit test (wall-slide test) is to assess static leg strength and endurance, particularly of the quadriceps and hip extensors","change in wall-sit test at 3 months",{"measure":31,"description":32,"timeFrame":33},"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","change in heel raise test at 3 months",{"measure":35,"description":36,"timeFrame":37},"blood biomarkers: serum creatinine kinase activity","Creatine kinase is to assess muscle damage.","change in serum creatinine kinase activity at 3 months",{"measure":39,"description":40,"timeFrame":41},"blood biomarkers: myostatin","Myostatin is to assess muscle damage","changes in serum myostatin at 3 months",{"measure":43,"description":44,"timeFrame":45},"blood biomarkers: atrogin 1","atrogin 1 is to assess muscle damage","changes in serum atrogin 1 at 3 months",{"measure":47,"description":48,"timeFrame":49},"blood biomarkers: hsCRP","hsCRP is to assess inflammation","changes in serum hsCRP at 3 months",{"measure":51,"description":52,"timeFrame":53},"blood biomarker: IL-6","IL-6 is to assess inflammation","changes in serum IL-6 at 3 months",{"measure":55,"description":56,"timeFrame":57},"blood lipid profiles","lipid profiles include total triglycerides, total cholesterol, HDL, and calculated LDL","changes in blood lipid profiles at 3 months",{"measure":59,"description":60,"timeFrame":61},"plasma menaquinone-4 (MK4) + menaquinone-4 (MK7)","MK4 and MK4 are vitamin K2 homologues and are measured by HPLC","changes in plasma MK4+MK7 at 3 months",null,{"allocation":64,"interventionModel":65,"interventionModelDescription":62,"primaryPurpose":66,"observationalModel":62,"timePerspective":62,"maskingInfo":67},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":68,"maskingDescription":62,"whoMasked":69},"TRIPLE",[70,71,72],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR","Statins are widely prescribed cholesterol-lowering oral drugs. The majority of reported adverse effects due to statin include muscle pain, weakness, cramp, and tiredness. CoQ10 supplementation has been widely used to reduce statin-related muscle complaints. Several human studies have been reported with inconsistent effects of CoQ10 on statin-related symptoms. This study is to investigate the role of 3-month annatto-derived geranylgeraniol (GG) in statin-related muscle outcomes in humans. Qualified subjects will be matched by age, gender, and body weight, and then randomly assigned to a no GG group, a low GG dose group, or a high GG dose group. The outcome measures will be assessed at baseline and after 3 months. Muscle-associated measurements will be recorded using subject questionnaires (also follow-up after 3 and 6 months), muscle performance results, and blood samples. We will monitor the safety of subjects after 3 months. Food intake, physical activity, and medication changes will be recorded at baseline and after 3 months. All data will be analyzed statistically.",[75,81,87],{"label":76,"type":77,"description":78,"interventionNames":79},"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",[80],"Dietary Supplement: Placebo",{"label":82,"type":83,"description":84,"interventionNames":85},"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",[86],"Dietary Supplement: Low GG",{"label":88,"type":83,"description":89,"interventionNames":90},"High GG","HIGH GG group: subject will take one pill (150 mg GG) after breakfast and another pill (150 mg GG) after dinner",[91],"Dietary Supplement: High GG",[93,97,100],{"type":94,"name":76,"description":95,"armGroupLabels":96,"otherNames":62},"DIETARY_SUPPLEMENT","300 mg olive oil",[76],{"type":94,"name":82,"description":98,"armGroupLabels":99,"otherNames":62},"150 mg GG",[82],{"type":94,"name":88,"description":101,"armGroupLabels":102,"otherNames":62},"300 mg GG",[88],[104],{"name":105,"affiliation":106,"role":107},"Chwan-Li (Leslie) Shen, PhD","Texas Tech Health Science Center","PRINCIPAL_INVESTIGATOR",[109],{"name":105,"role":110,"phone":111,"phoneExt":62,"email":112},"CONTACT","8067432815","leslie.shen@ttuhsc.edu",[114],{"facility":5,"status":115,"city":116,"state":117,"zip":118,"country":119,"countryCode":120,"cosmosGeoPoint":121,"geoPoint":126,"contacts":127},"RECRUITING","Lubbock","Texas","79430","United States","US",{"type":122,"coordinates":123},"Point",[124,125],-101.85517,33.57786,{"lat":125,"lon":124},[128,131],{"name":105,"role":110,"phone":129,"phoneExt":62,"email":130},"806-743-2815","Leslie.Shen@ttuhsc.edu",{"name":105,"role":107,"phone":62,"phoneExt":62,"email":62},{"type":133,"investigatorFullName":62,"investigatorTitle":62,"investigatorAffiliation":62,"oldNameTitle":62,"oldOrganization":62},"SPONSOR","100463263",false,"NCT05312424","Annatto-derived GG for Statin-associated Myopathy","Effect of Annatto-derived Geranylgeraniol (GG) on Statin-associated Myopathy","GG-statin","Inclusion Criteria:\n\n* Age ≥40 of either sex\n* Statin-treated patients with muscle pain alone or accompanied by other symptoms.\n* Patients currently receiving a statin who developed new-onset myalgias in within 90 day of initiation or a dosage increase\n\nExclusion Criteria:\n\n* Malignancy or significant neurological or psychiatric disturbances, including alcohol or drug abuse.\n* Woman who is pregnant, breastfeeding, or of childbearing potential and not taking adequate contraceptive precautions.\n* Had CoQ10 supplement one month before starting the study.\n* Genetic musculoskeletal and neurologic disorder known to affect skeletal muscle metabolism\n* Had steroid medication one month before starting the study.",true,"ALL","40 Years",{"count":145,"type":146},95,"ESTIMATED","INTERVENTIONAL",[149,150],"PHASE1","PHASE2","To evaluate the effects of 3-months annatto-derived geranylgeraniol (GG) supplementation on statin-associated skeletal muscle health.",[153],"Myopathy; Primary","2025-09-05",{"date":156,"type":157},"2025-09-12","ACTUAL",{"date":159,"type":157},"2022-07-15",{"date":161,"type":146},"2027-12-31",{"name":5,"class":6},1]