Clinical trial NCT01578629: NUTRITION: Natural Tocotrienol Against Ischemic Stroke Event
Official title: Human Blood Outcomes Following Tocotrienol Supplementation - NUTRITION Phase I and Phase IIA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Ischemic Stroke
Transient Ischemic Attack (TIA)
Keywords: stroke
ischemia
TIA
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Government of Malaysia
First posted: 2012-04-17
Enrollment: 210
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Phase IA

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

Exclusion Criteria - (as self reported by potential participants during review of eligibility criteria with Research Nurse,)

* 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)
* Medication exclusion criteria - current use or recent discontinuation (within last 28 days) of any medication including the following: anti-coagulants and blood-thinners (e.g., Warfarin), psychotropic medications including antipsychotics, mood-stabilizers (e.g., lithium, valproic acid, carbamazepine/tegretol); anti-depressants (tricyclics, SSRI's, MAOI's, nonselective MAOIs, Wellbutrin, St. John's Wort); anti-anxiety/anti-panic agents; anti-obsessive agents; prescription stimulants (e.g., Provigil, Ritalin); diet pills/anorectics; daily medication for chronic pain (e.g., opiates) or muscle spasms; daily use of over the counter stimulants in pill form (e.g., ephedrine); daily medication for asthma, Parkinson's disease medications (e.g., levodopa, methyldopa, apomorphine), smoking cessation medications (Wellbutrin/Zyban, Chantix/varenicline); statin use is not grounds for exclusion.

Phase IIA

Inclusion Criteria:

* 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
* 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)
* Medication exclusion criteria - current use or recent discontinuation (within last 28 days) of any medication including the following: anti-coagulants and blood-thinners (e.g., Warfarin), psychotropic medications including antipsychotics, mood-stabilizers (e.g., lithium, valproic acid, carbamazepine/tegretol); anti-depressants (tricyclics, SSRI's, MAOI's, nonselective MAOIs, Wellbutrin, St. John's Wort); anti-anxiety/anti-panic agents; anti-obsessive agents; prescription stimulants (e.g., Provigil, Ritalin); diet pills/anorectics; daily medication for chronic pain (e.g., opiates) or muscle spasms; daily use of over the counter stimulants in pill form (e.g., ephedrine); daily medication for asthma, Parkinson's disease medications (e.g., levodopa, methyldopa, apomorphine), smoking cessation medications (Wellbutrin/Zyban, Chantix/varenicline)

Primary outcomes:
measure: Platelet function panel
timeFrame: up to one year
measure: Lipid profile
timeFrame: up to one year
Secondary outcomes:
measure: Tape Stripping Test
timeFrame: up to one year
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio state University Medical Center
state: Ohio
Study officials:
References: