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| Name | Class |
|---|---|
| Carotech Inc. | INDUSTRY |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator | To surgery patients, Tocotrienol capsules. 200mg (2 100mg capsules) to take by mouth twice daily to total 400mg daily |
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| Arm 2 | Active Comparator | To surgery patients, Tocopherol capsules. 200mg (2 100mg capsules) to take by mouth twice daily to total 400mg daily |
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| Arm 3 | Active Comparator | Tocotrienol to healthy subjects - 200 mg to take orally two times a day (400 mg a day). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| To surgery patients, Tocopherol capsules. | Dietary Supplement | 200mg (2 100mg capsules) to take by mouth twice daily to total 400mg daily |
|
| Measure | Description | 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) | After at least 1 month of supplementation |
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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:
Inclusion Criteria Aim 2:
Exclusion Criteria Aim 1:
Exclusion Criteria Aim 2:
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| Name | Affiliation | Role |
|---|---|---|
| Chandan Sen, PhD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University | Columbus | Ohio | 43211 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22298568 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1- Surgery + Tocotrienol 200 mg | Surgery Patients to take Tocotrienol capsules.: 200mg (two 100mg capsules) taken by mouth twice to total 400mg daily |
| FG001 | Arm 2- Surgery + Tocopherol 200 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Tocotrienol to healthy subjects. | Dietary Supplement | 200 mg to take orally two times a day (400 mg a day). |
|
| To surgery patients, Tocotrienol capsules. | Dietary Supplement | 200mg (2 100mg capsules) to take by mouth twice daily to total 400mg daily |
|
Surgery Patients to take Tocopherol capsules.: 200mg (two 100mg capsules) taken by mouth twice to total 400mg daily
| FG002 | Arm 3- Healthy +Tocotrienol 400 mg | Healthy patients to take Tocotrienol: 400 mg to take orally (two 200 mg capsules) two times a day. |
| COMPLETED |
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| NOT COMPLETED |
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The healthy participants included: age 21-40 y, good health, nonsmoker, nonpregnant or nonbreastfeeding, and no recent (past 6 mo) or current use of supplements containing vitamin E. The surgical participants group included adipose, brain, cardiac muscle, and liver tissue of the surgical participants age 21 and older.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1- Surgical + Tocotrienol 200 mg | Surgical Subjects will recieve either Tocotrienol: 200mg (two 100mg capsules) to take twice daily by mouth to make a total of 400mg per day |
| BG001 | Arm 2 - Surgical + Tocopherol 200 mg | Surgical Subjects will recieve Tocopherol: 200mg (two 100mg capsules) to take twice daily by mouth to make a total of 400mg per day |
| BG002 | Arm 3- Healthy + Tocotrienol 200 mg | Healthy Subjects will recieve either Tocotrienol: 200mg (two 100mg capsules) to take twice daily by mouth to make a total of 400mg per day |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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) | Box plots were used to determine outliers defined as values . the 75th percentile plus 1.5 times the IQR or values , the 25th percentile minus 1.5 times the IQR (20). Outliers were identified and it was determined that laboratory procedural errors were the cause and thus removed from the analysis. | Posted | Mean | Standard Deviation | nmol/g | After at least 1 month of supplementation |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 | Surgery patients to take Tocotrienol capsules.: 200mg (two 100mg capsules)taken by mouth twice with foold to make a total of 400mg daily | 0 | 40 | 0 | 40 | ||
| EG001 | Arm 2 | Surgery patients to take Tocopherol capsules.: 200mg (two 100mg capsules)taken by mouth twice with foold to make a total of 400mg daily | 0 | 15 | 0 | 15 | ||
| EG002 | Arm 3 | Healthy patients to take either Tocotrienol or Tocopherol: 200mg (two 100mg capsules)taken by mouth twice with foold to make a total of 400mg daily | 0 | 25 | 0 | 25 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Chandan K. Sen, PhD. Professor and Associate Dean | The Ohio State University Wexner Medical Center | 614-247-7658 | chandan.sen@osumc.edu |
| ID | Term |
|---|---|
| D058625 | End Stage Liver Disease |
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D024505 | Tocopherols |
| D024508 | Tocotrienols |
| ID | Term |
|---|---|
| D014810 | Vitamin E |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Male |
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