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Human Tissue Distribution of Orally Supplemented Natural Vitamin E Tocotrienol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00678834
Recruitment Status : Completed
First Posted : May 16, 2008
Results First Posted : September 16, 2014
Last Update Posted : September 16, 2014
Sponsor:
Collaborator:
Carotech Inc.
Information provided by (Responsible Party):
Chandan K Sen, Ohio State University

Study Description
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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

Condition or disease Intervention/treatment Phase
End Stage Cardiac Failure Pulmonary Failure End Stage Liver Disease Morbid Obesity Recalcitrant Epilepsy Requiring Surgery Healthy Subjects Dietary Supplement: To surgery patients, Tocopherol capsules. Dietary Supplement: Tocotrienol to healthy subjects. Dietary Supplement: To surgery patients, Tocotrienol capsules. Early Phase 1

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: Human Tissue Distribution of Orally Supplemented Natural Vitamin E Tocotrienol
Study Start Date : March 2006
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin E

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Arm 1
To surgery patients, Tocotrienol capsules. 200mg (2 100mg capsules) to take by mouth twice daily to total 400mg daily
 Dietary Supplement: To surgery patients, Tocotrienol capsules.
200mg (2 100mg capsules) to take by mouth twice daily to total 400mg daily
Active Comparator: Arm 2
To surgery patients, Tocopherol capsules. 200mg (2 100mg capsules) to take by mouth twice daily to total 400mg daily
 Dietary Supplement: To surgery patients, Tocopherol capsules.
200mg (2 100mg capsules) to take by mouth twice daily to total 400mg daily
Active Comparator: Arm 3
Tocotrienol to healthy subjects - 200 mg to take orally two times a day (400 mg a day).
 Dietary Supplement: Tocotrienol to healthy subjects.
200 mg to take orally two times a day (400 mg a day).


Outcome Measures
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Primary Outcome Measures :
  1. 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) [ Time Frame: After at least 1 month of supplementation ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00678834


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

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Responsible Party: Chandan K Sen, Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT00678834    
Other Study ID Numbers: 2005C0034
First Posted: May 16, 2008    Key Record Dates
Results First Posted: September 16, 2014
Last Update Posted: September 16, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Liver Diseases
End Stage Liver Disease
Heart Failure
Obesity, Morbid
Digestive System Diseases
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Liver Failure
Hepatic Insufficiency
 Heart Diseases
Cardiovascular Diseases
Tocopherols
Vitamin E
Tocotrienols
alpha-Tocopherol
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients