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The aim of our study was to investigate the NK cell activity alternations and related cytokine changes in comparison with soybean oil used formula (control) and the canola and flaxseed oil used n-3 fatty acid enriched formula (n3EN, test) with non-surgical hospitalized patients for rehabilitation.
Patients were randomized to receive one of two types of enteral nutrition formula: soybean oil used enteral nutrition (control), vegetable (canola, flaxseed) derived n-3 fatty acid enriched enteral nutrition (n3EN). Blood samples were collected on the first day and 14 days after consumption of each formula and anthropometric parameters were collected. Hematology and biochemical values were analyzed and NK cell activities and serum cytokine productions were measured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| n-3 fatty acid enriched formula | Experimental | Those assigned to the n3EN group received vegetable n-3 fatty acid enriched formula by tube feeding (product; Yonsei Dairy Co., Seoul, South Korea). vegetable (canola, flaxseed) derived n-3 fatty acid |
|
| soybean oil used formula | Placebo Comparator | Patients assigned to the control group received a soybean used formula by tube feeding. soybean used formula |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vegetable (canola, flaxseed) derived n-3 fatty acid | Dietary Supplement | vegetable (canola, flaxseed) derived n-3 fatty acid was used for fat source. |
|
| Measure | Description | Time Frame |
|---|---|---|
| NK cell activity | NK cell activity (%) | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| cytokine values | (IL-12, IFN-γ, IL-1β , IL-6 and TNF-α) | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 30, 2018 | Aug 16, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014675 | Vegetables |
| D008043 | Linseed Oil |
| D013024 | Soybean Oil |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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The ready-to-use soybean used formula and n3EN formula had identical packaging with no differences in appearance, texture, or smell.
| soybean oil | Dietary Supplement | soybean oil used formula |
|
| D005224 |
| Fats, Unsaturated |
| D005223 | Fats |
| D008055 | Lipids |
| D010938 | Plant Oils |
| D009821 | Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |