Effect of Immune-enhancing Enteral Nutrition Formula Enriched With Vegetable Derived n-3 Fatty Acids on NK Cell Activity in Hospitalized Patients for Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 主要终点
- NK cell activity
研究概览
简要总结
The aim of our study was to investigate the NK cell activity alternations and related cytokine changes in comparison with soybean oil used formula (control) and the canola and flaxseed oil used n-3 fatty acid enriched formula (n3EN, test) with non-surgical hospitalized patients for rehabilitation.
详细描述
Patients were randomized to receive one of two types of enteral nutrition formula: soybean oil used enteral nutrition (control), vegetable (canola, flaxseed) derived n-3 fatty acid enriched enteral nutrition (n3EN). Blood samples were collected on the first day and 14 days after consumption of each formula and anthropometric parameters were collected. Hematology and biochemical values were analyzed and NK cell activities and serum cytokine productions were measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
The ready-to-use soybean used formula and n3EN formula had identical packaging with no differences in appearance, texture, or smell.
入排标准
- 年龄范围
- 19 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who were admitted to the Severance Hospital Rehabilitation Department , enteral tube feeding patient, Adult male and female patients aged 19 years and over, Patients who signed the consent form
排除标准
- •Patient with nausea
- •Patients with hepatic impairment (total bilirubin concentration> 3.5 mg / dl)
- •Patients with renal impairment (serum creatinine concentration> 3 mg / dl or requiring peritoneal or hemodialysis) diabetic patients
- •Patients who are undergoing chemotherapy or who are within 1 month of the end of chemotherapy
- •Patients whose life expectancy is less than 1 month
- •Pregnant women and women who are pregnant
研究组 & 干预措施
n-3 fatty acid enriched formula
Those assigned to the n3EN group received vegetable n-3 fatty acid enriched formula by tube feeding (product; Yonsei Dairy Co., Seoul, South Korea).
vegetable (canola, flaxseed) derived n-3 fatty acid
干预措施: vegetable (canola, flaxseed) derived n-3 fatty acid (Dietary Supplement)
soybean oil used formula
Patients assigned to the control group received a soybean used formula by tube feeding.
soybean used formula
干预措施: soybean oil (Dietary Supplement)
结局指标
主要结局
NK cell activity
时间窗: Baseline
NK cell activity (%)
次要结局
- cytokine values(Baseline)
研究者
Jong Ho Lee
Professor, Principal Investigator
Yonsei University