Human Tissue Distribution of Orally Supplemented Natural Vitamin E Tocotrienol
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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 |
- 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 |
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| United States, Ohio | |
| The Ohio State University | |
| Columbus, Ohio, United States, 43211 | |
| 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 Tocopherols Tocotrienols Vitamins Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents |
ClinicalTrials.gov processed this record on May 22, 2013