Human Tissue Distribution of Orally Supplemented Natural Vitamin E Tocotrienol

NCT ID: NCT00678834

Last Updated: 2014-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2012-06-30

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.

Conditions

End Stage Cardiac Failure; Pulmonary Failure; End Stage Liver Disease; Morbid Obesity; Recalcitrant Epilepsy Requiring Surgery; Healthy Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

Arm 1

To surgery patients, Tocotrienol capsules. 200mg (2 100mg capsules) to take by mouth twice daily to total 400mg daily

Group Type: ACTIVE_COMPARATOR

To surgery patients, Tocotrienol capsules.

Intervention Type: DIETARY_SUPPLEMENT

200mg (2 100mg capsules) to take by mouth twice daily to total 400mg daily

Arm 2

To surgery patients, Tocopherol capsules. 200mg (2 100mg capsules) to take by mouth twice daily to total 400mg daily

Group Type: ACTIVE_COMPARATOR

To surgery patients, Tocopherol capsules.

Intervention Type: DIETARY_SUPPLEMENT

200mg (2 100mg capsules) to take by mouth twice daily to total 400mg daily

Arm 3

Tocotrienol to healthy subjects - 200 mg to take orally two times a day (400 mg a day).

Group Type: ACTIVE_COMPARATOR

Tocotrienol to healthy subjects.

Intervention Type: DIETARY_SUPPLEMENT

200 mg to take orally two times a day (400 mg a day).

Interventions

To surgery patients, Tocopherol capsules.

200mg (2 100mg capsules) to take by mouth twice daily to total 400mg daily

Intervention Type: DIETARY_SUPPLEMENT

Tocotrienol to healthy subjects.

200 mg to take orally two times a day (400 mg a day).

Intervention Type: DIETARY_SUPPLEMENT

To surgery patients, Tocotrienol capsules.

200mg (2 100mg capsules) to take by mouth twice daily to total 400mg daily

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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.

• 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

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.

• 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.

• 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Carotech Inc.

INDUSTRY

Sponsor Role: collaborator

Chandan K Sen

OTHER

Sponsor Role: lead

Responsible Party

Chandan K Sen

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Chandan Sen, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University

Columbus, Ohio, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 22298568 (View on PubMed)

Other Identifiers

2005C0034

Identifier Type: -

Identifier Source: org_study_id