CLINICAL TRIALS PROFILE FOR SOYBEAN OIL
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505(b)(2) Clinical Trials for Soybean Oil
| 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 | >Sponsor | >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 | Completed | 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 | Completed | 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 | >Sponsor | >Phase | >Start Date | >Summary |
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