Essential Fatty Acid Status & Immune Function in Parenteral Nutrition Patients

Geert Wanten

Status: Completed

Conditions: Intestinal Failure

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01986153

2013/475

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

60 participants in 2 patient groups

Home parenteral nutrition patients

Description:

Patients who receive home parenteral nutrition.

Healthy controls

Description:

Those who don't receive home parenteral nutrition and consume a normal diet.