| Eligibility |
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)
|
