Essential Fatty Acid Status & Immune Function in Parenteral Nutrition Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Essential Fatty Acid Status & Immune Function in Parenteral Nutrition Patients

Conditions
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Intestinal Failure

Participation Criteria
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Eligibility Criteria
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Home parenteral nutrition patients: Inclusion Criteria: home parenteral nutrition: at least 6 months with a minimum frequency of 5 times a week Exclusion Criteria: active immune modulating (underlying) disease use of immune suppressives use of oral fish oil substrates smoking more than 5 cigarettes/day do not eat more than 5 portions of fatty fish per week Healthy controls: Inclusion Criteria: age and sex matched healthy volunteer Exclusion Criteria: active immune modulating (underlying) disease use of immune suppressives use of oral fish oil substrates smoking more than 5 cigarettes/day do not eat more than 5 portions of fatty fish per week

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Home parenteral nutrition patients<br>Patients who receive home parenteral nutrition. | |
| Healthy controls<br>Those who don't receive home parenteral nutrition and consume a normal diet. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | On day of blood withdrawal | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fatty acid, essential, Immune system, Home parenteral nutrition