NUTRITION: Natural Tocotrienol Against Ischemic Stroke Event

Status Completed

Clinical Trial Summary

Clinical Trial Description

A natural form of vitamin E called tocotrienol (TCT), found in many common foods such as barley, decreases stroke size in animal models. Vitamin E has blood-thinning properties and lowers cholesterol, which make it a potential therapy for stroke prevention, though these effects are less well characterized for TCT. 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 prevention of 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 the following study related procedures, blood draw total 4 times, tape stripping (non-invasive procedure), BMI, and blood pressure measurement at each visit (every month). Participants in Phase-IIA will have blood drawn a total of 6 times, tape stripping, BMI and blood pressure measurement and participants will be in the study for 13 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01578629
Study type	Interventional
Source	Ohio State University
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	March 2012
Completion date	December 2018

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NUTRITION: Natural Tocotrienol Against Ischemic Stroke Event — NUTRITION

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms