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Last Updated: January 27, 2020

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CLINICAL TRIALS PROFILE FOR OLIVE OIL; SOYBEAN OIL

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505(b)(2) Clinical Trials for Olive Oil; Soybean Oil

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT00631085 Effect of Gamma Tocopherol Supplementation on Neutrophil Response to 20,000 EU of Clinical Center Reference Endotoxin in Normal Adults Completed National Center for Complementary and Integrative Health (NCCIH) Phase 1 2008-05-01 The purpose of this research study is to learn whether high dose vitamin E (gamma tocopherol) will affect the way your body responds to an acute inflammation in your lungs. Vitamin E is found in soybean and vegetable oils as well as many plant seeds. Gamma tocopherol (gT), a component of vitamin E, composes 70-80% of Vitamin E in the U.S. diet. Alpha tocopherol (aT), another large component of vitamin E, makes up less than 10% of vitamin E in the U.S. diet, but is the major form in blood and tissue. It is also the major form of Vitamin E in over-the-counter supplements. However, gT has anti-inflammatory properties which are not present in aT. Preliminary data suggests that gT protects from ozone-induced exacerbation in animal studies, and previous studies have shown levels of gT are inversely associated with heart disease. We will ask you to undergo a challenge with endotoxin, which is a bacterial component of air pollution. From other studies we have done, we know that if you inhale 20,000 EUs (endotoxin units) we will see an increase in the number of neutrophils (a type of white blood cell that your body produces to fight infection) in your lung cells without causing you to have flu-like symptoms. We will investigate if there is a change in your lung inflammatory cells after the endotoxin challenge when you take the gT versus when you take a placebo.
OTC NCT00631085 Effect of Gamma Tocopherol Supplementation on Neutrophil Response to 20,000 EU of Clinical Center Reference Endotoxin in Normal Adults Completed University of North Carolina, Chapel Hill Phase 1 2008-05-01 The purpose of this research study is to learn whether high dose vitamin E (gamma tocopherol) will affect the way your body responds to an acute inflammation in your lungs. Vitamin E is found in soybean and vegetable oils as well as many plant seeds. Gamma tocopherol (gT), a component of vitamin E, composes 70-80% of Vitamin E in the U.S. diet. Alpha tocopherol (aT), another large component of vitamin E, makes up less than 10% of vitamin E in the U.S. diet, but is the major form in blood and tissue. It is also the major form of Vitamin E in over-the-counter supplements. However, gT has anti-inflammatory properties which are not present in aT. Preliminary data suggests that gT protects from ozone-induced exacerbation in animal studies, and previous studies have shown levels of gT are inversely associated with heart disease. We will ask you to undergo a challenge with endotoxin, which is a bacterial component of air pollution. From other studies we have done, we know that if you inhale 20,000 EUs (endotoxin units) we will see an increase in the number of neutrophils (a type of white blood cell that your body produces to fight infection) in your lung cells without causing you to have flu-like symptoms. We will investigate if there is a change in your lung inflammatory cells after the endotoxin challenge when you take the gT versus when you take a placebo.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Olive Oil; Soybean Oil

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00028548 XK469 in Treating Patients With Advanced Solid Tumors Completed National Cancer Institute (NCI) Phase 1 2002-01-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of XK469 in treating patients who have advanced solid tumors.
NCT00028548 XK469 in Treating Patients With Advanced Solid Tumors Completed Barbara Ann Karmanos Cancer Institute Phase 1 2002-01-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of XK469 in treating patients who have advanced solid tumors.
NCT00179556 Effects of Soy Isoflavones on Menopausal Hot Flashes Completed Nichimo - Tokyo, Japan Phase 2/Phase 3 2003-06-01 Hot flashes occur in three quarters of menopausal women, and can negatively impact quality of life. Interest has arisen in isoflavones, found in rich supply in soy products, as therapy for hot flashes. The study examines the effect of a new soy supplement, as compared to a placebo, in menopausal women on hot flash symptoms.
NCT00179556 Effects of Soy Isoflavones on Menopausal Hot Flashes Completed Beth Israel Deaconess Medical Center Phase 2/Phase 3 2003-06-01 Hot flashes occur in three quarters of menopausal women, and can negatively impact quality of life. Interest has arisen in isoflavones, found in rich supply in soy products, as therapy for hot flashes. The study examines the effect of a new soy supplement, as compared to a placebo, in menopausal women on hot flash symptoms.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Olive Oil; Soybean Oil

Condition Name

Condition Name for Olive Oil; Soybean Oil
Intervention Trials
Cholestasis 10
Total Parenteral Nutrition-induced Cholestasis 4
Inflammation 2
Parenteral Nutrition 2
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Condition MeSH

Condition MeSH for Olive Oil; Soybean Oil
Intervention Trials
Cholestasis 13
Liver Diseases 7
Premature Birth 3
Short Bowel Syndrome 2
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Clinical Trial Locations for Olive Oil; Soybean Oil

Trials by Country

Trials by Country for Olive Oil; Soybean Oil
Location Trials
United States 45
Spain 8
China 5
Canada 4
France 3
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Trials by US State

Trials by US State for Olive Oil; Soybean Oil
Location Trials
New York 6
California 5
Pennsylvania 3
Georgia 3
North Carolina 3
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Clinical Trial Progress for Olive Oil; Soybean Oil

Clinical Trial Phase

Clinical Trial Phase for Olive Oil; Soybean Oil
Clinical Trial Phase Trials
Phase 4 17
Phase 3 9
Phase 2/Phase 3 4
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Clinical Trial Status

Clinical Trial Status for Olive Oil; Soybean Oil
Clinical Trial Phase Trials
Completed 18
Recruiting 11
Unknown status 10
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Clinical Trial Sponsors for Olive Oil; Soybean Oil

Sponsor Name

Sponsor Name for Olive Oil; Soybean Oil
Sponsor Trials
Baxter Healthcare Corporation 4
Mayo Clinic 2
University of California, Los Angeles 2
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Sponsor Type

Sponsor Type for Olive Oil; Soybean Oil
Sponsor Trials
Other 65
Industry 12
NIH 7
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Serving leading biopharmaceutical companies globally:

Colorcon
Merck
McKinsey
Johnson and Johnson
Boehringer Ingelheim
Medtronic

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