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临床试验/NCT00734916
NCT00734916已完成不适用

Immune Modulation by Omega-3 Versus Omega-6 Based Parenteral Lipids in Healthy Volunteers

Radboud University Medical Center2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2008年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
2
主要终点
leukocyte counts

研究概览

简要总结

Immune modulating properties of parenteral lipid emulsions seem to contribute to the increased risk for infections which remains associated with the use of total parenteral nutrition. Emulsions based on soy bean oil (SO) are the oldest and still most widely used lipid source in TPN formulations but their high content of omega-6 polyunsaturated fatty acids (PUFAs) may be a drawback. Fish oil-based lipid emulsions (FO), rich in omega-3 PUFAs, has been approved for parenteral nutrition in many countries. Mainly retrospective studies on clinical outcomes in septic and postoperative patients have suggested clinical benefits with the inclusion of FO in parenteral nutrition regimens. The exact mechanisms behind the beneficial immunological effects of parenteral FO have, however, not yet been elucidated.

Objective:

To evaluate the effects of intravenous infusion of a FO-based lipid emulsion and a SO-based emulsion on immune function as evidenced by effects on peripheral blood leukocyte counts and functions and on the susceptibility to oxidative stress.

Study design:

Randomized placebo controlled cross-over pilot study with healthy volunteers.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

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

入选标准

  • Adult (>18 yrs of age)
  • Willingness to give written informed consent

排除标准

  • Smoking > 5 cigarettes/day
  • Diet with > 2 portions of fatty fish per day
  • Use of oral fish oil or vitamin substrates
  • History of metabolic disorder (especially diabetes or lipid disorders)
  • History of allergic, inflammatory of immunological disease
  • History of pulmonary, cardiovascular, renal or hematological disease
  • Medication use

结局指标

主要结局

leukocyte counts

时间窗: T=0, T=4 days, T=11 days

leukocyte functions

时间窗: T=0, T=4 days and T=11 days

(anti-)oxidant status

时间窗: T=0, T=4 days, T=11 days

次要结局

  • plasma and leukocyte cell membrane (phospho)lipid composition.(T=0, t=4 and T=11 days)

研究者

申办方类型
Other

研究点 (2)

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