Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Neuroprotective and Cardioprotective Effects Of Palm Vitamin E Tocotrienols

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00753532
Recruitment Status : Completed
First Posted : September 16, 2008
Last Update Posted : May 25, 2022
Sponsor:
Collaborator:
Malaysia Palm Oil Board
Information provided by (Responsible Party):
Yuen Kah Hay, Universiti Sains Malaysia

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of the study is to assess the neuroprotective, anti atherogenic and hepatoprotective properties of tocotrienols (palm vitamin E) supplementation as determined by white matter lesion load on serial magnetic resonance imaging (MRI), carotid artery magnetic resonance angiography (MRA) and liver ultrasound (US) as well as lipid profile analysis.

Condition or disease Intervention/treatment Phase
Cerebrovascular Disorders Dietary Supplement: 200mg of Palm vitamin E (tocotrienols) or placebo Phase 2

Detailed Description:

Stroke is the third largest cause of death after heart disease and cancer in Malaysia. It is estimated that 52,000 Malaysians suffer stroke annually. In 2005, 3245 cases of stroke were fatal. It is projected that the number of fatal stoke cases will exceed 25,000 in 2020.

It was found that at nanomolar concentrations, α-tocotrienol but not α-tocopherol prevent glutamate-induced neuron cell death in mice through inhibition of c-Src kinase and 12-lipoxygenase. Tocotrienol-supplemented rats showed more protection against stroke-induced injury compared with matched controls.

White matter lesion as detected on magnetic resonance imaging (MRI) is closely related to vascular events of the brain. MRI and histopathological study has shown that the larger white matter lesions not usually conforming to usual areas infarcts can actually represent areas of subclinical infarct. In addition there is positive correlation between white matter lesions with established vascular risk factors.

The Rotterdam Scan Study showed that elderly people with silent brain infarcts and white matter lesions are at a strongly increased risk of clinical stroke, which could not be explained by the major stroke risk factors alone.

Several recent studies showed that white matter lesions may be an independent prognostic measure of future stroke risk.

White matter hyperintensities as detected on MRI is closely related to vascular events of the brain and in some instances represent subclinical infarcts.

It is therefore conceivable to study the neuroprotective properties of tocotrienol supplementation in humans by looking at serial changes of white matter disease load.

Tocotrienol supplementation brings about various favourable effects including improving lipid profiles, lowering of thromboxane B2 and platelet factor 4 and reduced LDL oxidation. Carotid artery MR angiography is an established and robust technique in the evaluation of carotid artery stenosis. Therefore, to study the anti-atherogenic effects of tocotrienols supplementation, serial MR angiography of the carotid arteries are done.

Non-alcoholic fatty liver disease (NAFLD) is emerging as a not fully understood, both in aetiology and significance, liver disorder. FLD is reported to be the most common cause of chronic liver disease in the U.S.A. and other western countries with a prevalence rate ranging between 15% to 30% of the adult population. However, limited data are available for Malaysia.

US imaging provides valuable information of the liver condition with a sensitivity of 93-100%. Frequently NAFLD is associated with dyslipidemia, obesity, insulin resistance and type II diabetes and it represents the liver component of the metabolic syndrome (MetS). Patients with NAFLD are reported to have low levels of serum vitamin E. NAFLD patients present a significant increase in cardiovascular (CV) risk, thus linking NAFLD, MetS and accelerated atherosclerosis.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 241 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Double Blind Placebo Controlled Study On The Neuroprotective And Anti-Atherogenic Effects Of Palm TocotrienolRich Fraction(Palm Vitamin E)
Study Start Date : November 2007
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin E

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Placebo Comparator: MRI(+ve),
121 volunteers in MRI(+ve) cohort were randomized into two groups to receive either 200mg palm vitamin E (tocotrienols) softgel capsules or a identical looking placebo twice daily. 62 volunteers received 200mg palm vitamin E (tocotrienols) and the remaining 59 received placebo. They were followed up every 3 months for a period of 2 years for their blood biochemistry profile and MRI of the brain was conducted at baseline, 12 months and 24 months..
 Dietary Supplement: 200mg of Palm vitamin E (tocotrienols) or placebo
Individuals randomized in the (MRI+ve) and (MRI -ve) cohort respectively. In the MRI(+ve) cohort, 62 subjects received 200 mg softgels of Palm Vitamin E (tocotrienols) and 59 were assigned to placebo, taken orally twice a day for a study period of two years. In the MRI(-ve) cohort, 63 subjects received 200 mg softgels of Palm Vitamin E (tocotrienols) and 57 consumed placebo, taken twice a day for a follow up period of 1 year.
Other Name: Tocovid 200mg
Placebo Comparator: MRI(-ve)
120 volunteers in MRI(-ve) cohort were randomized into two groups to receive either 200mg palm vitamin E (tocotrienols) softgel capsules or a identical looking placebo twice daily. 63 volunteers received 200mg palm vitamin E (tocotrienols) and the remaining 57 received placebo. They were followed up every 3 months for a period of 1 year for their blood biochemistry profile and MRI of the brain was conducted at baseline and 12 months.
 Dietary Supplement: 200mg of Palm vitamin E (tocotrienols) or placebo
Individuals randomized in the (MRI+ve) and (MRI -ve) cohort respectively. In the MRI(+ve) cohort, 62 subjects received 200 mg softgels of Palm Vitamin E (tocotrienols) and 59 were assigned to placebo, taken orally twice a day for a study period of two years. In the MRI(-ve) cohort, 63 subjects received 200 mg softgels of Palm Vitamin E (tocotrienols) and 57 consumed placebo, taken twice a day for a follow up period of 1 year.
Other Name: Tocovid 200mg


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Regression of white matter lesion load in terms of numbers and size in the brain [ Time Frame: 1 to 2 years ]

Secondary Outcome Measures :
  1. Regression of the carotid artery stenoses in terms of percentage [ Time Frame: 1 to 2 years ]
  2. The improvement in the lipid profile other markers associated with increased cardiovascular risk [ Time Frame: 1 to 2 years ]
  3. Improvement in liver echogenicity. [ Time Frame: 1 to 2 years ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participant able to understand and has signed and dated the Informed Consent Form
  • Participant can be either a male or female
  • Participant is more than 35 years of age
  • Participant has total cholesterol between 5.2 - 6.2 mmol/L and LDL cholesterol between 2.6 - 4.2 mmol/L
  • Participant is able to comply with visits and medications
  • Participant has normal liver function (total protein, total albumin, total globulin, total bilirubin, SGOT and SGPT)

Participants who satisfy the Inclusion and Exclusion Criteria for Study in General with one or more of the following conditions will be eligible for MRI screening:

  • More than 40 years of age
  • Stable hypertension requiring only out-patient management
  • Diabetes mellitus requiring only out-patient management
  • Ischaemic heart disease requiring only out-patient management
  • Body mass index more than 25 (overweight or obese)

Exclusion Criteria:

  • Female participants who are pregnant
  • Participant has previously received vitamin E supplementation (tocotrienols or tocopherols) within the past 3 months at the time of recruitment
  • Participant has a history of cancer or has undergone radiation therapy
  • Participant has a history of major organ dysfunction, such as moderate or severe hepatic impairment, severe renal insufficiency, severe or unstable cardiovascular, respiratory, hematological, endocrinological, neurological or other somatic disorders resulting in previous hospitalization.
  • Participant has a neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol.
  • Participant is requiring long term anti-epileptics, hypnotics, and chronic medications for hypercholesterolemia
  • Participant has very high cholesterol levels, total cholesterol above 6.2 mmol/L and LDL cholesterol above 4.2 mmol/L, which require medical treatment.
  • Participant is requiring long term non-steroidal anti-inflammatory (NSAID) medication.
  • Participant has a history of hypersensitivity to vitamin E.
  • Participant has signs of alcohol and drug dependence or abuse.
  • Participant is unable to understand and comply with the elements in the consent form.

In addition, the participant must not have any contraindication to have MRI examinations including:

  • Biostimulators (e.g. cardiac pacemaker and implanted spinal cord stimulator)
  • Neurostimulators
  • Aneurysm clips in the brain
  • Cochlear implants
  • Hearing aids
  • Orthopaedic implants less than 2 months old
  • Metal fragments in eyes Any further implants or foreign body not listed above should have the safety assessed by a radiologist prior to recruitment into the MRI study.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00753532


Locations
Layout table for location information
Malaysia
Kepala Batas Hospital
Kepala Batas, Penang, Malaysia, 13200
Sponsors and Collaborators
Universiti Sains Malaysia
Malaysia Palm Oil Board
Investigators
Layout table for investigator information
Principal Investigator: Yuen Kah Hay, Phd Universiti Sains Malaysia
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Yuen Kah Hay, Professor, Universiti Sains Malaysia
ClinicalTrials.gov Identifier: NCT00753532    
Other Study ID Numbers: MPOB-USM-Version 1.4
First Posted: September 16, 2008    Key Record Dates
Last Update Posted: May 25, 2022
Last Verified: May 2022
Keywords provided by Yuen Kah Hay, Universiti Sains Malaysia:
Carotid artery stenoses
Brain ischaemia
stroke
Lipid abnormalities
Fatty Liver
Additional relevant MeSH terms:
Layout table for MeSH terms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Vitamin E
Tocopherols
 Tocotrienols
Tocovid
Vitamins
Micronutrients
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents