Essential Fatty Acid Status & Immune Function in Parenteral Nutrition Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 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)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •home parenteral nutrition: at least 6 months with a minimum frequency of 5 times a week
排除标准
- •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
结局指标
主要结局
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)
时间窗: On day of blood withdrawal
次要结局
- 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)
研究者
Geert Wanten
MD, PhD, MSc
Radboud University Medical Center