Human Tissue Distribution of Orally Supplemented Natural Vitamin E Tocotrienol

Healthy Subjects Clinical Trial

Official title:

Human Tissue Distribution of Orally Supplemented Natural Vitamin E Tocotrienol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00678834
• Other study ID #: 2005C0034
• Status: Completed
• Phase: Phase 0
• First received: May 14, 2008
• Last updated: September 8, 2014
• Start date: March 2006
• Est. completion date: June 2012

Study information

• Verified date: July 2014
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

Aim 1 Surgical candidate with a surgery schedule date with a time period of 4-24 weeks (<4 weeks will be excluded; last dose until 24h before surgery) In Aim 1 we expect to have patients, with diverse co-morbidity and medication conditions.

Patient Selection: Because of limitation in obtaining healthy human tissues (as in Aim 2), we plan to obtain these tissues from patients who are scheduled for the following surgeries for subjects in group one:

Heart Heart Transplant Heart Failure- Biopsy taken from diseased heart Lung Lung Transplant, Lung-wedge/resection, Lobectomy Cancer- Tissue sample taken from removed lung or resected portion of lung Liver Liver Transplant, Biopsy, Resection Hepatic Malignancy- Biopsy taken from resected portion of liver Adipose Tissue Panniculectomy Excessive Tissue of the Abdomen Brain & CSF Epilepsy Excised brain tissue and cerebrospinal fluid

To ensure higher enrollment we are not controlling for age of subjects as long as the subjects are 21 years of age or older.

Inclusion Criteria Aim 1:

• age 21 and older

• good health

• non- smoker

• no current medications

• non- pregnant or non-breastfeeding

• no previous use of OTC medications or other form of supplements containing vitamin-E.

Inclusion Criteria Aim 2:

• age 21 - 40 years

• good health

• non- smoker

• no current medications

• non- pregnant or non-breastfeeding

• no previous use of OTC medications or other form of supplements containing vitamin-E.

Exclusion Criteria Aim 1:

• Long-term use of OTC medications containing vitamin-E or current vitamin-E supplements

• Scheduled surgery date lesser than 4 weeks or greater than 24 weeks.

Exclusion Criteria Aim 2:

• Over 40 or under 21 years of age

• Current smoker

• Pregnant and breastfeeding

• Diabetes and HIV diagnosis

• Immunosuppression therapy

• Any neurological problems

• Long-term use of OTC medications containing vitamin-E or current vitamin-E supplements

• ETOH or drug abuse

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• To surgery patients, Tocopherol capsules.
200mg (2 100mg capsules) to take by mouth twice daily to total 400mg daily
• Tocotrienol to healthy subjects.
200 mg to take orally two times a day (400 mg a day).
• To surgery patients, Tocotrienol capsules.
200mg (2 100mg capsules) to take by mouth twice daily to total 400mg daily

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Chandan K Sen	Carotech Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Patel V, Rink C, Gordillo GM, Khanna S, Gnyawali U, Roy S, Shneker B, Ganesh K, Phillips G, More JL, Sarkar A, Kirkpatrick R, Elkhammas EA, Klatte E, Miller M, Firstenberg MS, Chiocca EA, Nesaretnam K, Sen CK. Oral tocotrienols are transported to human ti — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No