A Phase 1/2 interventional study of Placebo and Low GG in Myopathy; Primary, sponsored by Texas Tech University Health Sciences Center. Recruiting at 1 site in United States. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Texas Tech University Health Sciences Center · Phase 1/2, Interventional, and Treatment
To evaluate the effects of 3-months annatto-derived geranylgeraniol (GG) supplementation on statin-associated skeletal muscle health.
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.
232 studies on the registry are indexed under Muscular Diseases; 54 are open to participants now.
This study's planned enrollment of 95 is above the median of 38 across 134 interventional studies indexed under Muscular Diseases.
Browse Muscular Diseases studies →Texas Tech University Health Sciences Center is the lead sponsor of 100 studies on the registry; 14 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Placebo group: subject will take one pill (150 mg olive oil) after breakfast and another pill (150 mg olive oil) after dinner
Dietary Supplement: Placebo
LOW GG group: subject will take one pill (150 mg olive oil) after breakfast and another pill (150 mg GG) after dinner
Dietary Supplement: Low GG
HIGH GG group: subject will take one pill (150 mg GG) after breakfast and another pill (150 mg GG) after dinner
Dietary Supplement: High GG
300 mg olive oil
150 mg GG
300 mg GG
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 months
BPI
Brief Pain Inventory (BPI) is to assess pain and interference of pain with everyday life.
Time frame: change in BPI at 3 months
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 months
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 months
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 months
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 months
blood biomarkers: serum creatinine kinase activity
Creatine kinase is to assess muscle damage.
Time frame: change in serum creatinine kinase activity at 3 months
blood biomarkers: myostatin
Myostatin is to assess muscle damage
Time frame: changes in serum myostatin at 3 months
blood biomarkers: atrogin 1
atrogin 1 is to assess muscle damage
Time frame: changes in serum atrogin 1 at 3 months
blood biomarkers: hsCRP
hsCRP is to assess inflammation
Time frame: changes in serum hsCRP at 3 months
blood biomarker: IL-6
IL-6 is to assess inflammation
Time frame: changes in serum IL-6 at 3 months
blood lipid profiles
lipid profiles include total triglycerides, total cholesterol, HDL, and calculated LDL
Time frame: changes in blood lipid profiles at 3 months
plasma menaquinone-4 (MK4) + menaquinone-4 (MK7)
MK4 and MK4 are vitamin K2 homologues and are measured by HPLC
Time frame: changes in plasma MK4+MK7 at 3 months
Plan to share: No
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