Essential Fatty Acid Status & Immune Function in Parenteral Nutrition Patients

Completed

• Conditions: Intestinal Failure

• Registration Number: NCT01986153
• Lead Sponsor: Geert Wanten

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.

Study Timeline

• Status Verified: 2013-11
• Study First Submitted: 2013-11-11
• Study First Submitted QC: 2013-11-15
• Study First Posted: 2013-11-18
• Study Start: 2013-12
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Last Update Submitted: 2014-11-11
• Last Update Posted: 2014-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Gastroenterology and Hepatology; 🇳🇱 Nijmegen, Netherlands