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The research study is a parallel arm, randomized placebo-controlled clinical trial designed to assess changes in hepatic lipid accumulation, visceral adipose tissue and postprandial lipid, markers of inflammation and energy metabolism in participants who consume 3 study foods per day for 16 week, while maintaining their body weight.
The study objectives include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Soybean Oil | Experimental | Consumption of study foods each day made with soybean oil |
|
| Palm Oil | Placebo Comparator | Consumption of study foods each day made with palm oil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Soybean Oil Foods | Other | Three food product containing 10g of soybean oil each will be consumed each day for a today of 30g of soybean oil consumed each day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in ectopic liver lipids | To determine the impact of dietary soybean oil on ectopic liver fat measured through MRI | Week 0 and Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in visceral adipose tissue | To determine the impact of dietary soybean oil on visceral adipose tissue measured through MRI | Week 0 and Week 16 |
| Changes in postprandial lipids | To evaluate the effect of soybean oil supplementation on postprandial lipid panel including total cholesterol, HDL-Cholesterol, LDL-Cholesterol, Triglycerides |
| Measure | Description | Time Frame |
|---|---|---|
| Association of changes in plasma linoleic acid with ectopic liver lipids, visceral adipose tissue, and postprandial lipids, markers of inflammation and energy metabolism | Use multiple linear regressions to determine the association of change in plasma linoleic acid with changes in ectopic liver fat, visceral adipose, and postprandial total cholesterol, HDL-Cholesterol, LDL-Cholesterol, Triglycerides, L-6, Tumor necrosis factor, and C-reactive protein and indirect calorimetry |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Human Nutrition Laboratory | Columbus | Ohio | 43210 | United States |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| Palm Oil Foods | Other | Three food product containing 10g of palm oil each will be consumed each day for a today of 30g of palm oil consumed each day |
|
| Week 0 and Week 16 |
| Changes in postprandial markers of inflammation | To evaluate the effect of soybean oil supplementation on the postprandial IL-6, Tumor necrosis factor, and C-reactive protein in the blood | Week 0 and Week 16 |
| Changes in postprandial energy metabolism | To evaluate the effect of soybean oil supplementation on postprandial indirect calorimetry or respiratory gas exchange | Week 0 and Week 16 |
| Week 0 and Week 16 |
| Changes in cardiolipin species | To determine the impact of dietary soybean oil on peripheral blood mononuclear cell cardiolipin species measured using electrospray ionization-mass spectrometry coupled to high-performance liquid chromatography | Week 0 and Week 16 |
| Changes in mitochondria function | To determine the impact of dietary soybean oil on peripheral blood mononuclear cell mitochondria oxygen consumption rate using the seahorse assay | Week 0 and Week 16 |