NUTRITION: Natural Tocotrienol Against Ischemic Stroke Event (NUTRITION)

• ClinicalTrials.gov Identifier: NCT01578629
• Recruitment Status: Unknown
• First Posted: April 17, 2012
• Last Update Posted: March 21, 2018
• Sponsor: Chandan K Sen
• Collaborator: Government of Malaysia
• Information provided by (Responsible Party): Chandan K Sen, Ohio State University

Tracking Information

• First Submitted Date: April 5, 2012
• First Posted Date: April 17, 2012
• Last Update Posted Date: March 21, 2018
• Study Start Date: March 2012
• Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 13, 2012)

• Platelet function panel [ Time Frame: up to one year ]
  Blood draw followed by platelet aggregometry
• Lipid profile [ Time Frame: up to one year ]
  blood lipid panel including HDL, LDL, total cholesterol

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 13, 2012)

Tape Stripping Test [ Time Frame: up to one year ]

HPLC vitamin E analysis of tape strips for compliance

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: NUTRITION: Natural Tocotrienol Against Ischemic Stroke Event
• Official Title: Human Blood Outcomes Following Tocotrienol Supplementation - NUTRITION Phase I and Phase IIA
• 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.
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Health Services Research

Condition

• Ischemic Stroke
• Transient Ischemic Attack (TIA)

Intervention

• 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

Study Arms

• 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.
  Interventions:

  • Other: Vitamin E tocotrienol (TCT) capsules ; Low dose Aspirin
  • Other: Placebo vehicle control
• 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.
  Interventions:

  • Other: Vitamin E tocotrienol (TCT) capsules ; Low dose Aspirin
  • Other: Placebo vehicle control

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: April 13, 2012): 210
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2018
• Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01578629
• Other Study ID Numbers: 2011H0242
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Chandan K Sen, Ohio State University
• Study Sponsor: Chandan K Sen
• Collaborators: Government of Malaysia
• Investigators: Not Provided
• PRS Account: Ohio State University
• Verification Date: March 2018