NUTRITION: Natural Tocotrienol Against Ischemic Stroke Event

NCT01578629 | Completed Phase 1

• 1 other identifier: 2011H0242
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke; Transient Ischemic Attack (TIA)

Keywords

stroke; ischemia; TIA

Outcome Measures

Primary Outcomes (2)

• Platelet function panel

  Blood draw followed by platelet aggregometry

  up to one year

• Lipid profile

  blood lipid panel including HDL, LDL, total cholesterol

  up to one year

Secondary Outcomes (1)

• Tape Stripping Test

  up to one year

Study Arms (2)

Healthy Volunteers

ACTIVE COMPARATOR

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.

Other: Vitamin E tocotrienol (TCT) capsules ; Low dose Aspirin; Other: Placebo vehicle control

Hyperlipidemic

ACTIVE COMPARATOR

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.

Other: Vitamin E tocotrienol (TCT) capsules ; Low dose Aspirin; Other: Placebo vehicle control

Interventions

Vitamin E tocotrienol (TCT) capsules ; Low dose Aspirin OTHER

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

Healthy Volunteers; Hyperlipidemic

Placebo vehicle control OTHER

vehicle control compared to Vitamin E TCT pills

Also known as: placebo capsule

Healthy Volunteers; Hyperlipidemic

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Andrew Slivka: lead
• Government of Malaysia: collaborator

Study Sites (1)

The Ohio state University Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Ischemic Stroke; Ischemic Attack, Transient; Stroke; Ischemia

Interventions

Thrombin Time; Capsules; Aspirin

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Coagulation Tests; Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Dosage Forms; Pharmaceutical Preparations; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, Professor of Neurology

Study Record Dates

• First Submitted: April 5, 2012
• First Posted: April 17, 2012
• Study Start: March 1, 2012
• Primary Completion: November 1, 2018
• Study Completion: December 1, 2018
• Last Updated: September 20, 2021

Record last verified: 2021-09

Locations

US (1)