NUTRITION: Natural Tocotrienol Against Ischemic Stroke Event
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ischemic Stroke Transient Ischemic Attack (TIA) |
Other: Vitamin E tocotrienol (TCT) pills ; Low dose Aspirin |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Health Services Research |
| Official Title: | Human Blood Outcomes Following Tocotrienol Supplementation - NUTRITION Phase I and Phase IIA |
- Platelet function panel [ Time Frame: up to one year ] [ Designated as safety issue: Yes ]Blood draw followed by platelet aggregometry
- Lipid profile [ Time Frame: up to one year ] [ Designated as safety issue: No ]blood lipid panel including HDL, LDL, total cholesterol
- Tape Stripping Test [ Time Frame: up to one year ] [ Designated as safety issue: No ]HPLC vitamin E analysis of tape strips for compliance
| Estimated Enrollment: | 210 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Healthy Volunteers |
Other: Vitamin E tocotrienol (TCT) pills ; Low dose Aspirin
Vitamin E TCT pills- 400-800 mg Aspirin- 81 mg
|
| Active Comparator: Hyperlipidemic |
Other: Vitamin E tocotrienol (TCT) pills ; Low dose Aspirin
Vitamin E TCT pills- 400-800 mg Aspirin- 81 mg
|
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 prevent 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 following study related procedures,blood draw total 3 times, tape stripping(non-invasive procedure) and blood pressure measurement in each visit (every month). For participants in Phase-IIA will have total 5 times blood draw, tape stripping and blood pressure measurement and participants will be in the study for 12 months.
Eligibility| Ages Eligible for Study: | 40 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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 6mos; within the past 5 years)
- No current vitamin E supplementation in multi-vitamin
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)
Contacts and Locations| Contact: Cameron Rink, PhD | 614-202-2861 | cameron.rink@osumc.edu |
| United States, Ohio | |
| The Ohio state University Medical Center | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: Cameron Rink cameron.rink@osumc.edu | |
| Principal Investigator: Chandan K Sen, Ph.D. | |
| Sub-Investigator: Andrew Slivka, MD | |
| Sub-Investigator: Cameron Rink, PhD | |
More Information
No publications provided
| Responsible Party: | Chandan K Sen, Professor, The Ohio State University |
| ClinicalTrials.gov Identifier: | NCT01578629 History of Changes |
| Other Study ID Numbers: | 2011H0242 |
| Study First Received: | April 5, 2012 |
| Last Updated: | November 28, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Ohio State University:
|
stroke ischemia TIA |
Additional relevant MeSH terms:
|
Vitamin E Alpha-Tocopherol Tocopherols Tocotrienols Ischemic Attack, Transient Ischemia Stroke Cerebral Infarction Brain Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
Pathologic Processes Brain Infarction Aspirin Vitamins Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Fibrinolytic Agents |
ClinicalTrials.gov processed this record on May 22, 2013