NUTRITION: Natural Tocotrienol Against Ischemic Stroke Event "NUTRITION"

Recruiting

Phase 1/2 Results N/A

Trial 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.

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.

Conditions

Interventions

  • Vitamin E tocotrienol (TCT) pills ; Low dose Aspirin Other
    Intervention Desc: Vitamin E TCT pills- 400-800 mg Aspirin- 81 mg
    ARM 1: Kind: Experimental
    Label: Healthy Volunteers
    ARM 2: Kind: Experimental
    Label: Hyperlipidemic
  • Vitamin E tocotrienol (TCT) capsules ; Low dose Aspirin Other
    Intervention Desc: Vitamin E TCT capsules- 400-800 mg Aspirin- 81 mg
    ARM 1: Kind: Experimental
    Label: Healthy Volunteers
    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 2: Kind: Experimental
    Label: Hyperlipidemic
    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.
  • Placebo vehicle control Other
    Other Names: placebo capsule
    Intervention Desc: vehicle control compared to Vitamin E TCT pills
    ARM 1: Kind: Experimental
    Label: Healthy Volunteers
    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 2: Kind: Experimental
    Label: Hyperlipidemic
    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.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator)
  • Purpose: Health Services Research
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Platelet function panel up to one year Yes
Primary Lipid profile up to one year No
Secondary Tape Stripping Test up to one year No

Sponsors