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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

Tracking Information
First Submitted Date  ICMJE May 14, 2008
First Posted Date  ICMJE May 16, 2008
Results First Submitted Date  ICMJE July 2, 2014
Results First Posted Date  ICMJE September 16, 2014
Last Update Posted Date September 16, 2014
Study Start Date  ICMJE March 2006
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2014)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 14, 2008)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Human Tissue Distribution of Orally Supplemented Natural Vitamin E Tocotrienol
Official Title  ICMJE Human Tissue Distribution of Orally Supplemented Natural Vitamin E Tocotrienol
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Condition  ICMJE
  • End Stage Cardiac Failure
  • Pulmonary Failure
  • End Stage Liver Disease
  • Morbid Obesity
  • Recalcitrant Epilepsy Requiring Surgery
  • Healthy Subjects
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Arm 1
    To surgery patients, Tocotrienol capsules. 200mg (2 100mg capsules) to take by mouth twice daily to total 400mg daily
    Intervention: Dietary Supplement: To surgery patients, Tocotrienol capsules.
  • Active Comparator: Arm 2
    To surgery patients, Tocopherol capsules. 200mg (2 100mg capsules) to take by mouth twice daily to total 400mg daily
    Intervention: Dietary Supplement: To surgery patients, Tocopherol capsules.
  • Active Comparator: Arm 3
    Tocotrienol to healthy subjects - 200 mg to take orally two times a day (400 mg a day).
    Intervention: Dietary Supplement: Tocotrienol to healthy subjects.
Publications * 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 tissues and delay the progression of the model for end-stage liver disease score in patients. J Nutr. 2012 Mar;142(3):513-9. doi: 10.3945/jn.111.151902. Epub 2012 Feb 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 19, 2012)
80
Original Estimated Enrollment  ICMJE
 (submitted: May 14, 2008)
140
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00678834
Other Study ID Numbers  ICMJE 2005C0034
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chandan K Sen, Ohio State University
Study Sponsor  ICMJE Chandan K Sen
Collaborators  ICMJE Carotech Inc.
Investigators  ICMJE
Principal Investigator: Chandan Sen, PhD Ohio State University
PRS Account Ohio State University
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP