Human Tissue Distribution of Orally Supplemented Natural Vitamin E Tocotrienol

This study has been completed.
Sponsor:
Collaborator:
Carotech Inc.
Information provided by (Responsible Party):
Chandan K Sen, The Ohio State University
ClinicalTrials.gov Identifier:
NCT00678834
First received: May 14, 2008
Last updated: September 19, 2012
Last verified: September 2012
  Purpose

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


Condition Intervention Phase
End Stage Cardiac Failure
Pulmonary Failure
End Stage Liver Disease
Morbid Obesity
Recalcitrant Epilepsy Requiring Surgery
Healthy Subjects
Dietary Supplement: To surgery patients, Tocotrienol or Tocopherol capsules.
Dietary Supplement: Tocotrienol or Tocopherol to healthy subjects.
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Human Tissue Distribution of Orally Supplemented Natural Vitamin E Tocotrienol

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • The levels of TCT in the tissues of "not-healthy" subjects and in the tissue of "healthy" subjects following oral supplementation (200 mg x 2 per day for 4-24 weeks) [ Time Frame: After at least 1 month of supplementation ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: March 2006
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1 Dietary Supplement: To surgery patients, Tocotrienol or Tocopherol capsules.
200mg (2 100mg capsules) to take by mouth twice daily to total 400mg daily
Arm 2 Dietary Supplement: Tocotrienol or Tocopherol to healthy subjects.
200 mg to take orally two times a day.

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 - 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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00678834

Locations
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43211
Sponsors and Collaborators
Chandan K Sen
Carotech Inc.
Investigators
Principal Investigator: Chandan Sen, PhD Ohio State University
  More Information

Publications:
Responsible Party: Chandan K Sen, Professor, The Ohio State University
ClinicalTrials.gov Identifier: NCT00678834     History of Changes
Other Study ID Numbers: 2005C0034
Study First Received: May 14, 2008
Last Updated: September 19, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Epilepsy
Heart Failure
Liver Diseases
Obesity
Obesity, Morbid
End Stage Liver Disease
Respiratory Insufficiency
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Heart Diseases
Cardiovascular Diseases
Digestive System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Liver Failure
Hepatic Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Vitamin E
Alpha-Tocopherol
Tocopherols
Tocotrienols
Vitamins
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014