Ongoing
Objective: Plan to conduct two trials (I & IIA) to determine the effects of orally supplemented TCT on platelet function and cholesterol.
Study type: Interventional
Study Design: Randomized, Double-blind
Subjects: Phase I – healthy volunteers; Phase IIa- hyperlipidemic subjects
Intervention: Tocotrienol, low dose aspirin
Primary Outcome: 1) Platelet function panel. Blood draw followed by platelet aggregometry.
2) Lipid profile. Blood lipid panel including HDL, LDL, total cholesterol
Secondary Outcome: Tape Stripping Test. HPLC vitamin E analysis of tape strips for compliance
Methodology: We plan to conduct two trials (I & IIA) to determine the effects of orally supplemented TCT on platelet function and cholesterol. Phase I subjects will be healthy volunteers, recruited by an advertisement. Phase IIA subjects will be hyperlipidemic (having high cholesterol), and will be referred to us by their Wound Care Center Physicians. Patients will be randomized to receive placebo pills, (400 or 800 mg) TCT pills, low-dose 81 mg aspirin (commonly used for secondary prevent stroke), or TCT and aspirin together. potential subjects for Phase-I who meet study criteria and agree to participate will be in the study for 6 months and have following study related procedures,blood draw total 3 times, tape stripping(non-invasive procedure) and blood pressure measurement in each visit (every month). For participants in Phase-IIA will have total 5 times blood draw, tape stripping and blood pressure measurement and participants will be in the study for 12 months.