NUTRITION: Natural Tocotrienol Against Ischemic Stroke Event
关键词
抽象
描述
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.
日期
| 最后验证: | 02/28/2018 |
| 首次提交: | 04/04/2012 |
| 提交的预估入学人数: | 04/12/2012 |
| 首次发布: | 04/16/2012 |
| 上次提交的更新: | 03/19/2018 |
| 最近更新发布: | 03/20/2018 |
| 实际学习开始日期: | 02/29/2012 |
| 预计主要完成日期: | 10/31/2018 |
| 预计完成日期: | 11/30/2018 |
状况或疾病
干预/治疗
Other: Vitamin E tocotrienol (TCT) capsules ; Low dose Aspirin
Other: Placebo vehicle control
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Active Comparator: 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. | |
| Active Comparator: 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. |
资格标准
| 有资格学习的年龄 | 40 Years 至 40 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | 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) |
结果
主要结果指标
1. Platelet function panel [up to one year]
2. Lipid profile [up to one year]
次要成果指标
1. Tape Stripping Test [up to one year]
