NUTRITION: Natural Tocotrienol Against Ischemic Stroke Event

NCT ID: NCT01578629

Last Updated: 2021-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2018-12-31

Brief 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Healthy Volunteers

Healthy participants randomized into one of 6 groups that will take 4 capsules, twice a day of vitamin E tocotrienol (TCT) capsules ; Low Dose Aspirin or placebo capsule for 7 months.

Group Type: ACTIVE_COMPARATOR

Vitamin E tocotrienol (TCT) capsules ; Low dose Aspirin

Intervention Type: OTHER

Vitamin E TCT capsules- 400-800 mg Aspirin- 81 mg

Placebo vehicle control

Intervention Type: OTHER

vehicle control compared to Vitamin E TCT pills

Hyperlipidemic

hyperlipidemic patients randomized into one of 6 groups that will take 4 capsules, twice a day of Vitamin E Tocotrienol (TCT) capsules; Low Dose Aspirin or placebo vehicle control capsule for 7 months.

Group Type: ACTIVE_COMPARATOR

Vitamin E tocotrienol (TCT) capsules ; Low dose Aspirin

Intervention Type: OTHER

Vitamin E TCT capsules- 400-800 mg Aspirin- 81 mg

Placebo vehicle control

Intervention Type: OTHER

vehicle control compared to Vitamin E TCT pills

Interventions

Vitamin E tocotrienol (TCT) capsules ; Low dose Aspirin

Vitamin E TCT capsules- 400-800 mg Aspirin- 81 mg

Intervention Type: OTHER

Placebo vehicle control

vehicle control compared to Vitamin E TCT pills

Intervention Type: OTHER

Other Intervention Names

placebo capsule

Eligibility Criteria

Inclusion Criteria

• Healthy subjects between 40 and 70 years of age
• No history of long-term vitamin E supplement (defined as daily oral tocopherol or tocotrienol supplementation greater than or equal to 6mos; within the past 5 years)
• No current vitamin E supplementation in multivitamin

• Hyperlipidemic patients between 40 and 70 years of age currently taking statins
• LDL>130mg/dL
• TG>150mg/dL
• HDL<40mg/dL
• No history of long-term vitamin E supplement (defined as daily oral tocopherol or tocotrienol supplementation greater than or equal to 6mos; within the past 5 years)
• No current vitamin E supplementation in multivitamin

Exclusion Criteria

• Evidence of heart disease as diagnosed by a physician by one or more of the following tests; EKG, chest x-ray, stress test, tilt table test, echocardiogram, coronary angiogram, electrophysiology test, CT heart scan, coronary MRI, pericardiocentesis
• High cholesterol (total cholesterol >240mg/dL, LDL>160mg/dL)
• Prior cancer diagnosis
• Pregnancy - To exclude the possibility of pregnant women entering the study or becoming pregnant during the study only post-menopausal women or women who have had hysterectomies or bilateral oophorectomies will be included.
• Breast feeding
• Smoker (Must have quit 5 or more years ago)
• Alcohol dependence (>4 drinks per day for more than 1yr anytime in the last 3 years)

Phase IIA

• Evidence of heart disease as diagnosed by a physician by one or more of the following tests; EKG, chest x-ray, stress test, tilt table test, echocardiogram, coronary angiogram, electrophysiology test, CT heart scan, coronary MRI, pericardiocentesis
• Prior cancer diagnosis
• Currently taking blood thinners
• Pregnancy - To exclude the possibility of pregnant women entering the study or becoming pregnant during the study only post-menopausal women or women who have had hysterectomies or bilateral oophorectomy will be included.
• Breast feeding
• Smoking (Must have quit within the past 6 months)
• Alcohol dependence - (>4 drinks per day for more than 1yr anytime in the last 3 years)

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Government of Malaysia

UNKNOWN

Sponsor Role: collaborator

Andrew Slivka

OTHER

Sponsor Role: lead

Responsible Party

Andrew Slivka

MD, Professor of Neurology

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

The Ohio state University Medical Center

Columbus, Ohio, United States

Countries

United States

Other Identifiers

2011H0242

Identifier Type: -

Identifier Source: org_study_id