Essential Fatty Acid Status & Immune Function in Parenteral Nutrition Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01986153

Enrollment

Registered

2013-11-18

Start date

2013-12-31

Completion date

2014-11-30

Last updated

2014-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intestinal Failure

Keywords

Fatty acid, essential, Immune system, Home parenteral nutrition

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

Inclusion 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

Design outcomes

Primary

Measure	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

Measure	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

Countries

Netherlands

Outcome results