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| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
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The purpose of this study is to determine if patients on long-term olive oil-based parenteral nutrition have an adequate essential fatty acid status and immune status, compared to age- and sex-matched healthy controls.
Patients, who suffer from severe chronic intestinal failure and whose nutritional intake cannot be met by oral food intake, have as their final option total parenteral nutrition, which contains all necessary macro- and micronutrients. Lipid emulsions are essential for these patients as they are a source of non glucose fuel calories, and they contain (essential) fatty acids which are important as structural component for many cells in the human body. Home parenteral nutrition patients are at risk for essential fatty acid deficiency. Data are lacking that indicate the optimal amount of essential fatty acids required for these patients. The latter seems especially relevant for patients receiving lipid prescriptions which are low in essential fatty acids, like ClinOleic®. Long-term parenteral nutrition dependent patients successfully use ClinOleic®. It is however unknown whether these patient remain to have an adequate essential fatty acid status in the long run.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home parenteral nutrition patients | Patients who receive home parenteral nutrition. | ||
| Healthy controls | Those who don't receive home parenteral nutrition and consume a normal diet. |
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| Measure | Description | Time Frame |
|---|---|---|
| Essential fatty acid status of plasma phospholipids and peripheral blood mononuclear cells, including the biochemical determination of the Holman index (ratio of mead acid/ arachidonic acid) | On day of blood withdrawal |
| Measure | Description | Time Frame |
|---|---|---|
| Physical examination of clinical signs/symptoms of essential fatty acid deficiency | On day of blood withdrawal | |
| Immune function: expression of cell surface markers, stimulus-induced reactive oxygen species production, cytokine production by leukocytes |
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Home parenteral nutrition patients:
Inclusion Criteria:
Exclusion Criteria:
Healthy controls:
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Exclusion Criteria:
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Long-term parenteral nutrition dependent patients:Patients who visit the outpatient clinic of the Department of Gastroenterology and Hepatology at the Radboud University Medical Nijmegen Center.
Healthy controls: volunteers who are residents in the Netherlands.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology and Hepatology | Nijmegen | 6525 GA | Netherlands |
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| ID | Term |
|---|---|
| D000090124 | Intestinal Failure |
| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| On day of blood withdrawal |