- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00678834
Human Tissue Distribution of Orally Supplemented Natural Vitamin E Tocotrienol
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
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Ohio
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Columbus, Ohio, United States, 43211
- The Ohio State University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / 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
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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
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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).
|
200 mg to take orally two times a day (400 mg a day).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
After at least 1 month of supplementation
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Chandan Sen, PhD, Ohio State University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Liver Failure
- Hepatic Insufficiency
- Heart Diseases
- Cardiovascular Diseases
- Overnutrition
- Nutrition Disorders
- Overweight
- Body Weight
- Obesity
- Liver Diseases
- End Stage Liver Disease
- Heart Failure
- Obesity, Morbid
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Protective Agents
- Micronutrients
- Vitamins
- Antioxidants
- Vitamin E
- Tocopherols
- alpha-Tocopherol
- Tocotrienols
Other Study ID Numbers
- 2005C0034
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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