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NUTRITION: Natural Tocotrienol Against Ischemic Stroke Event (NUTRITION)

Primary Purpose

Ischemic Stroke, Transient Ischemic Attack (TIA)

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Vitamin E tocotrienol (TCT) capsules ; Low dose Aspirin
Placebo vehicle control
Sponsored by
Andrew Slivka
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Ischemic Stroke focused on measuring stroke, ischemia, TIA

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • The Ohio state University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Healthy Volunteers

Hyperlipidemic

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Platelet function panel
Blood draw followed by platelet aggregometry
Lipid profile
blood lipid panel including HDL, LDL, total cholesterol

Secondary Outcome Measures

Tape Stripping Test
HPLC vitamin E analysis of tape strips for compliance

Full Information

First Posted
April 5, 2012
Last Updated
September 13, 2021
Sponsor
Andrew Slivka
Collaborators
Government of Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT01578629
Brief Title
NUTRITION: Natural Tocotrienol Against Ischemic Stroke Event
Acronym
NUTRITION
Official Title
Human Blood Outcomes Following Tocotrienol Supplementation - NUTRITION Phase I and Phase IIA
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Andrew Slivka
Collaborators
Government of Malaysia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Transient Ischemic Attack (TIA)
Keywords
stroke, ischemia, TIA

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
210 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy Volunteers
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Hyperlipidemic
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Vitamin E tocotrienol (TCT) capsules ; Low dose Aspirin
Intervention Description
Vitamin E TCT capsules- 400-800 mg Aspirin- 81 mg
Intervention Type
Other
Intervention Name(s)
Placebo vehicle control
Other Intervention Name(s)
placebo capsule
Intervention Description
vehicle control compared to Vitamin E TCT pills
Primary Outcome Measure Information:
Title
Platelet function panel
Description
Blood draw followed by platelet aggregometry
Time Frame
up to one year
Title
Lipid profile
Description
blood lipid panel including HDL, LDL, total cholesterol
Time Frame
up to one year
Secondary Outcome Measure Information:
Title
Tape Stripping Test
Description
HPLC vitamin E analysis of tape strips for compliance
Time Frame
up to one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Facility Information:
Facility Name
The Ohio state University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

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