Effects of Enteral Formula Including Immune-modulating Nutrients on Clinical Course and Immune Function in Critically Ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Change from baseline NK cell activity at 7 days
研究概览
简要总结
To determine whether high-protein (24% of total calorie from protein) enteral nutrition of immune modulating nutrients (eg, ω-3 fatty acids and antioxidants) enriched with β-glucan stimulates immune functions compared with standard enteral nutrition (control: 20% of total calorie from protein) or high-protein (24% of total calorie from protein) enteral nutrition of immune modulating nutrients without β-glucan in critically ill patients.
详细描述
To determine whether high-protein (24% of total calorie from protein) enteral nutrition of immune modulating nutrients (eg, ω-3 fatty acids and antioxidants) enriched with β-glucan stimulates immune functions compared with standard enteral nutrition (control: 20% of total calorie from protein) or high-protein (24% of total calorie from protein) enteral nutrition of immune modulating nutrients without β-glucan in critically ill patients. In a randomized double-blind placebo-controlled study, 30 patients consumed 1 of 3 enteral nutrition: control, enteral nutrition of immune modulating nutrients enriched with β-glucan (250mg/L) or enteral nutrition of immune modulating nutrients without β-glucan. Enteral nutrition was initiated within 24 hours of ICU admission and continued during the ICU stay for a 7 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ICU patients
排除标准
- •ICU patients who could not receiving enteral nutrition
研究组 & 干预措施
control group
standard enteral nutrition
干预措施: standard enteral nutrition (Dietary Supplement)
test group I
high-protein enteral nutrition of immune modulating nutrients enriched with β-glucan
干预措施: high-protein enteral nutrition of immune modulating nutrients enriched with β-glucan (Dietary Supplement)
test group II
high-protein enteral nutrition of immune modulating nutrients without β-glucan
干预措施: high-protein enteral nutrition of immune modulating nutrients without β-glucan (Dietary Supplement)
结局指标
主要结局
Change from baseline NK cell activity at 7 days
时间窗: at baseline and 7 days follow-up
NK cell activity (%)
次要结局
- Change from baseline IL-12 at 7 days(at baseline and 7 days follow-up)
- Change from baseline hs-CRP at 7 days(at baseline and 7 days follow-up)