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Last Updated: October 25, 2020

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CLINICAL TRIALS PROFILE FOR SOYBEAN OIL

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505(b)(2) Clinical Trials for 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 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.
NCT00211848 Antiviral & Antifibrotic Liver Therapy in HCV + Drinkers and Non-Drinkers Unknown status Hoffmann-La Roche Phase 2 2000-06-01 The primary aim of this investigation is to evaluate the effect of a combined antiviral, antifibrotic and antioxidant treatment on the progression of liver disease in patients with hepatitis C who either abstain from alcohol or continue to drink. All subjects are given state-of-the-art antiviral treatment (pegylated interferon + ribavirin), supplemented with either placebo or polyenylphosphatidylcholine (PPC), a purified soybean extract consisting of 95-96% polyunsaturated phosphatidylcholines (PC) and which has both antifibrotic and antioxidant properties. Secondary aims are to verify whether moderate alcohol consumption interferes with the antiviral effect of pegylated interferon + ribavirin on HCV and to validate the reliability of various circulating markers as substitute for liver biopsies to indicate the stage of liver pathology and its propensity for progression.
NCT00211848 Antiviral & Antifibrotic Liver Therapy in HCV + Drinkers and Non-Drinkers Unknown status National Institute on Alcohol Abuse and Alcoholism (NIAAA) Phase 2 2000-06-01 The primary aim of this investigation is to evaluate the effect of a combined antiviral, antifibrotic and antioxidant treatment on the progression of liver disease in patients with hepatitis C who either abstain from alcohol or continue to drink. All subjects are given state-of-the-art antiviral treatment (pegylated interferon + ribavirin), supplemented with either placebo or polyenylphosphatidylcholine (PPC), a purified soybean extract consisting of 95-96% polyunsaturated phosphatidylcholines (PC) and which has both antifibrotic and antioxidant properties. Secondary aims are to verify whether moderate alcohol consumption interferes with the antiviral effect of pegylated interferon + ribavirin on HCV and to validate the reliability of various circulating markers as substitute for liver biopsies to indicate the stage of liver pathology and its propensity for progression.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Soybean Oil

Condition Name

Condition Name for Soybean Oil
Intervention Trials
Cholestasis 10
Total Parenteral Nutrition-induced Cholestasis 4
Short Bowel Syndrome 2
Home Parenteral Nutrition 2
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Condition MeSH

Condition MeSH for Soybean Oil
Intervention Trials
Cholestasis 13
Liver Diseases 8
Premature Birth 4
Insulin Resistance 3
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Clinical Trial Locations for Soybean Oil

Trials by Country

Trials by Country for Soybean Oil
Location Trials
United States 49
Spain 8
China 5
Canada 4
France 3
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Trials by US State

Trials by US State for Soybean Oil
Location Trials
New York 6
California 5
North Carolina 4
Pennsylvania 3
Georgia 3
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Clinical Trial Progress for Soybean Oil

Clinical Trial Phase

Clinical Trial Phase for Soybean Oil
Clinical Trial Phase Trials
Phase 4 19
Phase 3 9
Phase 2/Phase 3 4
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Clinical Trial Status

Clinical Trial Status for Soybean Oil
Clinical Trial Phase Trials
Completed 18
Recruiting 12
Unknown status 10
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Clinical Trial Sponsors for Soybean Oil

Sponsor Name

Sponsor Name for Soybean Oil
Sponsor Trials
Baxter Healthcare Corporation 5
Mayo Clinic 2
University of California, Los Angeles 2
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Sponsor Type

Sponsor Type for Soybean Oil
Sponsor Trials
Other 67
Industry 13
NIH 7
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Serving leading biopharmaceutical companies globally:

McKesson
Harvard Business School
Merck
Medtronic
Moodys
Baxter

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