NCT00678834

Human Tissue Distribution of Orally Supplemented Natural Vitamin E Tocotrienol

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Chandan K Sen · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	To surgery patients, Tocopherol capsules.	200mg (2 100mg capsules) to take by mouth twice daily to total 400mg daily
DIETARY_SUPPLEMENT	Tocotrienol to healthy subjects.	200 mg to take orally two times a day (400 mg a day).
DIETARY_SUPPLEMENT	To surgery patients, Tocotrienol capsules.	200mg (2 100mg capsules) to take by mouth twice daily to total 400mg daily

Timeline

• Start date: 2006-03-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2008-05-16
• Last updated: 2014-09-16
• Results posted: 2014-09-16

Locations

1 site across 1 country: United States