Essential Fatty Acid Status & Immune Function in Parenteral Nutrition Patients
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.
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Case Control
Time Perspective: Cross-Sectional
|Target Follow-Up Duration:||1 Day|
|Official Title:||Essential Fatty Acid Status & Immune Function in Parenteral Nutrition Patients|
- 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) [ Time Frame: On day of blood withdrawal ] [ Designated as safety issue: No ]
- Physical examination of clinical signs/symptoms of essential fatty acid deficiency [ Time Frame: On day of blood withdrawal ] [ Designated as safety issue: No ]
- Immune function: expression of cell surface markers, stimulus-induced reactive oxygen species production, cytokine production by leukocytes [ Time Frame: On day of blood withdrawal ] [ Designated as safety issue: No ]
|Study Start Date:||December 2013|
|Estimated Study Completion Date:||March 2014|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Home parenteral nutrition patients
Patients who receive home parenteral nutrition.
Those who don't receive home parenteral nutrition and consume a normal diet.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01986153
|Contact: Geert Wanten, MD PhD MSc||+31 24 3614760||Geert.Wanten@radboudumc.nl|
|Department of Gastroenterology and Hepatology||Not yet recruiting|
|Nijmegen, Netherlands, 6525 GA|
|Contact: Geert Wanten, MD PhD MSc +31 24 3614760 Geert.Wanten@radboudumc.nl|