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Completed

NCT Number: NCT01986153

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.

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Key information

Conditions

Intestinal Failure Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Gastroenterology and Hepatology

Nijmegen, 6525 GA, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Physical examination of clinical signs/symptoms of essential fatty acid deficiency

    Time frame: On day of blood withdrawal

  2. Immune function: expression of cell surface markers, stimulus-induced reactive oxygen species production, cytokine production by leukocytes

    Time frame: On day of blood withdrawal

Sponsors and collaborators

Lead sponsor

Geert Wanten

Other

Collaborators

  • Baxter Healthcare Corporation

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 18, 2013
Registry last updated
Nov 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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