Clinical trial NCT01986153: Essential Fatty Acid Status & Immune Function in Parenteral Nutrition Patients
Official title: Essential Fatty Acid Status & Immune Function in Parenteral Nutrition Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intestinal Failure
Keywords: Fatty acid, essential
Immune system
Home parenteral nutrition
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2013-11-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: On day of blood withdrawal
Secondary outcomes:
measure: Physical examination of clinical signs/symptoms of essential fatty acid deficiency
timeFrame: On day of blood withdrawal
measure: Immune function: expression of cell surface markers, stimulus-induced reactive oxygen species production, cytokine production by leukocytes
timeFrame: On day of blood withdrawal
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Department of Gastroenterology and Hepatology
Study officials:
References: