Human Tissue Distribution of Orally Supplemented Natural Vitamin E Tocotrienol

Early Phase 1

Completed

Conditions: End Stage Cardiac Failure
End Stage Liver Disease
Pulmonary Failure
Morbid Obesity
Recalcitrant Epilepsy Requiring Surgery
Healthy Subjects

Interventions: Dietary Supplement: To surgery patients, Tocotrienol capsules.
Dietary Supplement: To surgery patients, Tocopherol capsules.
Dietary Supplement: Tocotrienol to healthy subjects.

Brief Summary: Levels of tocotrienol in human tissues following supplementation is not currently known. The objective of this present study is to determine the levels of this form of vitamin E in the human tissues such as skin, heart, lung, liver, adipose tissue, Brain and cerebrospinal fluid (CSF) following oral supplementation

Detailed Description: In nature, there are eight members in the vitamin E family: a-, b-, g- and d-TCP, and a-, b-, g- and d-tocotrienol (TCT). Vitamin E research has developed highly asymmetrically. Out of the 25,000+ papers on vitamin E in the PubMed, 99% deal with tocopherols. Recent research has demonstrated the lack of cancer-preventive effects and potential adverse health consequences of tocopherol (6). As a result, more attention has been turned towards non-tocopherol forms of vitamin E (16). Palm oil represents a major source of natural TCT. TCT possess powerful neuroprotective, antioxidant, anti-cancer and cholesterol lowering properties that often differ from the properties of TCP (15).

During the last five years, our and other laboratories have reported several striking beneficial properties of tocotrienols in experimental settings. One major concern that limits enthusiasm for tocotrienol for humans is the report that the vitamin E transporting protein, tocopherol-transport protein (TTP), has a very low affinity to transport tocotrienol. Using TTP-knock out mice, we have recently demonstrated that oral TCT is effectively carried to vital organs and that such transport can take place independent of TTP. With that background, the purpose of this project is to test the hypothesis that orally supplemented tocotrienol reaches the vital organs of humans.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Arm 1	To surgery patients, Tocotrienol capsules.	To surgery patients, Tocotrienol capsules. 200mg (2 100mg capsules) to take by mouth twice daily to total 400mg daily
Arm 2	To surgery patients, Tocopherol capsules.	To surgery patients, Tocopherol capsules. 200mg (2 100mg capsules) to take by mouth twice daily to total 400mg daily
Arm 3	Tocotrienol to healthy subjects.	Tocotrienol to healthy subjects - 200 mg to take orally two times a day (400 mg a day).

Primary Outcome Measures

Name	Time	Method
The Levels of TCT in the Tissues of "Non-healthy" Subjects and in the Tissue of "Healthy" Subjects Following Oral Supplementation (200 mg x 2 Per Day for 4-24 Weeks)	After at least 1 month of supplementation

Secondary Outcome Measures