None listed
Conditions
Brief summary
Hypercholesterolemia treatment is a challenging task in the modern internal medicine. Diet, exercise and inhibitors of HMG-CoA reductase (statins) inhibitors are among therapeutic options in the hypercholesterolemia. However statins are poorly absorbed in the intestine and have a low bioavailability. Microencapsulation methods are shown to increase intestinal absorption and bioavailability of many drugs. We hypothesize that microencapsulation of statins with lycopene will increase bioavailbility of simvastatin and will enhance its therapeutic effect.
Interventions
Each volunteer will be given once daily at the evening time 20 mg lycosome-formulated simvastatin fused with 7 mg of lycopene or the same amount (20 mg) of unmodified simvastatin with no lycopene. Control patients will be given 7 mg of lycopene alone. All study products will be given orally for a period of 4 weeks. Adherence to the study protocol will be monitored by questioning of the patients and plasma measurements of simvastatin at the end of interventional period.
Sponsors
Lycotec Ltd, Cambridge, UK
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Major inclusion criteria were as follows: Caucasian male or female subjects 40-65 years old, elevated total plasma cholesterol (over 200 mg/dl), elevated plasma LDL (over 150 mg/dl), plasma markers for oxidative stress LDL-Px ELISA ×103 over 250 microM/ml and IOD over 40 microM/mL, absence of concomitant intake of anti-hypertensive, lipid-lowering or any other cardiovascular drugs.
Exclusion criteria
Among exclusion criteria were: (1)Unwillingness to sign informed consent. (2) Unable to comply with the protocol for the duration of the study. (3) History of MI in the 3 months preceding the study. (4) Ejection fraction (EF) higher than 45%. (5) Significant medical condition that would impact safety considerations (e.g., significantly elevated LFT, hepatitis, severe dermatitis, uncontrolled diabetes, cancer, severe GI disease, fibromyalgia, renal failure, recent CVA (cerebrovascular accident), pancreatitis, respiratory diseases, epilepsy, etc.). (6) Compulsive alcohol abuse (more than 10 drinks weekly), or regular exposure to other substances of abuse. (7) Participation in other nutritional or pharmaceutical studies. (8) Resting heart rate of more than 100 beats per minute or less than 45 beats per minute. inability to comply with the study protocol, severe medical conditions (hepatitis, pancreatitis, uncontrolled diabetes, cancer, recent cardiovascular events, tuberculosis etc).
Outcome results
None listed