NUTRITION: Natural Tocotrienol Against Ischemic Stroke Event

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Ohio State University
Sponsor:
Collaborator:
Government of Malaysia
Information provided by (Responsible Party):
Chandan K Sen, The Ohio State University
ClinicalTrials.gov Identifier:
NCT01578629
First received: April 5, 2012
Last updated: August 21, 2014
Last verified: August 2014

April 5, 2012
August 21, 2014
March 2012
December 2016   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01578629 on ClinicalTrials.gov Archive Site
Tape Stripping Test [ Time Frame: up to one year ] [ Designated as safety issue: No ]
HPLC vitamin E analysis of tape strips for compliance
Same as current
Not Provided
Not Provided
 
NUTRITION: Natural Tocotrienol Against Ischemic Stroke Event
Human Blood Outcomes Following Tocotrienol Supplementation - NUTRITION Phase I and Phase IIA

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Health Services Research
  • Ischemic Stroke
  • Transient Ischemic Attack (TIA)
Other: Vitamin E tocotrienol (TCT) pills ; Low dose Aspirin
Vitamin E TCT pills- 400-800 mg Aspirin- 81 mg
  • Active Comparator: Healthy Volunteers
    Intervention: Other: Vitamin E tocotrienol (TCT) pills ; Low dose Aspirin
  • Active Comparator: Hyperlipidemic
    Intervention: Other: Vitamin E tocotrienol (TCT) pills ; Low dose Aspirin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
210
December 2016
December 2016   (final data collection date for primary outcome measure)

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)
Both
40 Years to 70 Years
Yes
Contact: Cameron Rink, PhD 614-202-2861 cameron.rink@osumc.edu
Contact: David Paoletto, RN 614-366-3515 david.paoletto@osumc.edu
United States
 
NCT01578629
2011H0242
No
Chandan K Sen, The Ohio State University
Chandan K Sen
Government of Malaysia
Not Provided
Ohio State University
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP