NCT01578629

NUTRITION: Natural Tocotrienol Against Ischemic Stroke Event

Human Blood Outcomes Following Tocotrienol Supplementation - NUTRITION Phase I and Phase IIA

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: Andrew Slivka · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Ischemic Stroke
• Transient Ischemic Attack (TIA)

Interventions

Type	Name	Description
OTHER	Vitamin E tocotrienol (TCT) capsules ; Low dose Aspirin	Vitamin E TCT capsules- 400-800 mg Aspirin- 81 mg
OTHER	Placebo vehicle control	vehicle control compared to Vitamin E TCT pills

Timeline

• Start date: 2012-03-01
• Primary completion: 2018-11-01
• Completion: 2018-12-01
• First posted: 2012-04-17
• Last updated: 2021-09-20

Locations

1 site across 1 country: United States