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NUTRITION: Natural Tocotrienol Against Ischemic Stroke Event (NUTRITION)

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ClinicalTrials.gov Identifier: NCT01578629
Recruitment Status : Unknown
Verified March 2018 by Chandan K Sen, Ohio State University.
Recruitment status was:  Active, not recruiting
First Posted : April 17, 2012
Last Update Posted : March 21, 2018
Sponsor:
Collaborator:
Government of Malaysia
Information provided by (Responsible Party):
Chandan K Sen, Ohio State University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Transient Ischemic Attack (TIA) Other: Vitamin E tocotrienol (TCT) capsules ; Low dose Aspirin Other: Placebo vehicle control Phase 1 Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
Official Title: Human Blood Outcomes Following Tocotrienol Supplementation - NUTRITION Phase I and Phase IIA
Study Start Date : March 2012
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin E

Arms and Interventions
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Arm Intervention/treatment
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.
 Other: Vitamin E tocotrienol (TCT) capsules ; Low dose Aspirin
Vitamin E TCT capsules- 400-800 mg Aspirin- 81 mg

Other: Placebo vehicle control
vehicle control compared to Vitamin E TCT pills
Other Name: placebo capsule
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.
 Other: Vitamin E tocotrienol (TCT) capsules ; Low dose Aspirin
Vitamin E TCT capsules- 400-800 mg Aspirin- 81 mg

Other: Placebo vehicle control
vehicle control compared to Vitamin E TCT pills
Other Name: placebo capsule


Outcome Measures
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Primary Outcome Measures :
  1. Platelet function panel [ Time Frame: up to one year ]
    Blood draw followed by platelet aggregometry

  2. Lipid profile [ Time Frame: up to one year ]
    blood lipid panel including HDL, LDL, total cholesterol


Secondary Outcome Measures :
  1. Tape Stripping Test [ Time Frame: up to one year ]
    HPLC vitamin E analysis of tape strips for compliance


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01578629


Locations
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United States, Ohio
The Ohio state University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Chandan K Sen
Government of Malaysia
More Information
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Responsible Party: Chandan K Sen, Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT01578629    
Other Study ID Numbers: 2011H0242
First Posted: April 17, 2012    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018
Keywords provided by Chandan K Sen, Ohio State University:
stroke
ischemia
TIA
Additional relevant MeSH terms:
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Stroke
Ischemic Attack, Transient
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Ischemia
Aspirin
Vitamin E
Tocopherols
Tocotrienols
 Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action