Effects of a Supplement Derived From Palm Oil on Cholesterol Levels in the Blood

Both tocotrienols and tocopherols, whose derivatives are in eight different isoforms, are
closely related structurally. Tocopherols are generally present in common vegetable oils
(i.e. soy, canola). However, tocotrienols are concentrated in cereal grains (ie. oat, barley,
and rye, rice bran), with the highest level found in crude palm oil. The development of new
cholesterol-lowering agents has been given more and more attention by pharmaceutical
companies due to the strong relationship between cholesterol and atherosclerosis.
Tocotrienols, especially δ- and γ-tocotrienols, were shown to be effective nutritional agents
to treat high cholesterol in recent research programs. In particular, γ-tocotrienol appears
to inhibit 3-hydroxy-3-methylglutaryl-coenzyme A reductase at a posttranscriptional level and
there is some evidence that tocopherols antagonize this effect. Therefore, the current study
is designed to demonstrate that treatment with a tocotrienol-enriched fraction of palm oil
for a three month period will lead to a significant reduction in LDL cholesterol with no
effect on HDL cholesterol in patients whose cholesterol level is not adequately controlled in
spite of statins. This objective will be achieved utilizing a simple three arm randomized
placebo-controlled trial in a total of 99 subjects After acclimation to a step I AHA diet and
no supplemental vitamin E in the diet, subjects will be given either a placebo capsule or a
tocotrienol (120mg or 240mg) capsule in addition to their statin medications

Inclusion Criteria:

- Able to read, speak, and understand English

- Male or female, 35-70 years old (inclusive)

- Total Fasting Plasma Cholesterol of >180 mg/dl

- Currently taking statin medications.

- Willing to maintain AHA Step 1 diet for the duration of the study.

Exclusion Criteria:

- Any subject who is taking vitamin E supplements or taking any antibiotics or other
medication or dietary supplement which could interfere with the action of
tocotrienols.

- Any subject who is taking cholesterol lowering medications other than statins.

- Any subject who has lost >5% of their body weight during the past 3 months.

- Any subjects with a history of gastrointestinal surgery, diabetes mellitus, or other
serious medical condition, such as chronic hepatitis or renal disease, bleeding
disorder, congestive heart disease, chronic diarrhea disorders, myocardial infarction,
coronary artery bypass graft, angioplasty within 6 months prior to screening, current
diagnosis of uncontrolled hypertension (defined as BP >160mmHg, diastolic BP>95mmHg),
active or chronic gastrointestinal disorders, bulimia, anorexia, laxative abuse, or
endocrine diseases (except thyroid disease requiring medication) as indicated by
medical history or routine physical examination.

- Major surgery within 12 weeks prior to subject randomization and/or screening,
especially cardiac surgery

- Is currently a smoker who has a therapeutic plan to quit smoking anytime during the
study period; or if not a current smoker, has quit smoking within the past 3 months.

- Known HIV positive or known immunocompromised condition (e.g. MV, organ
transplantation, treatment with immunosuppressant medications).

- Clinical evidence of current malignancy with the exception of basal cell or squamous
cell carcinoma of the skin and cervical intraepithelial neoplasia.

- Currently receiving systemic chemotherapy and/or radiotherapy.

- Active bleeding.

- Subject has any disorder (excluding illiteracy or visual impairment) that compromises
the ability of the subject to give written informed consent and/or to comply with
study procedures.

- In the opinion of the study investigator has a risk of non-compliance with study
procedures, or cannot read, understand or complete study related materials.