The Immune-enhancing Effect of Supplementation With Fermented Maillard Reacted Whey Protein in Nondiabetic and Nonobese Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Natural killer cell activity
研究概览
简要总结
To investigate the impact of supplementing fermented Maillard reacted whey protein (F-MRP) on natural killer (NK) cell activity, circulating cytokines and serum protein levels.
详细描述
A randomized, double-blind, placebo-controlled study was conducted on 80 participant without diabetes and obesity. Over a 8-week testing period, the F-MRP group consumed 6 g of powder containing 4.2 g F-MRP each day, whereas the placebo group consumed the same amount with dextrin. NK cell activity (%) was measured based on the ratios of effector cells (E; peripheral blood mononuclear cells, PBMCs) from each participant to target cells (T; K562 cells) at E:T= 10:1, 5:1, 2.5:1, or 1.25:1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to give informed consent
- •The levels of white blood cells within range 3x10^3/μL~8x10^3/μL
- •Males and females
- •20-70 years old
- •Without no severe complications
排除标准
- •White blood cell under 3x10^3/μL or over 8x10^3/μL
- •Pregnancy or breast-feeding
- •Hypersensitivity or disease history for milk protein
- •Liver disease, inflammation disease, or severe kidney failure disease
- •Cancer, lung disease, leukemia, or autoimmune disease
- •Psychological or neurological disease
- •Myocardiac infarction or cerebrovascular diseases within 6 months before screening
- •Consumption of other test products or drugs within 1 month before screening
- •Inflammation related disease within 1 month before screening
结局指标
主要结局
Natural killer cell activity
时间窗: At 8-week follow-up
Change from baseline natural killer cell activity at 8-week
时间窗: At baseline and 8-week follow-up
次要结局
- Interleukin-12(At 8-week follow-up)
- Change from baseline Interleukin-12 at 8-week(At baseline and 8-week follow-up)
- Interferon-gamma(At 8-week follow-up)
- Change from baseline Interferon-gamma at 8-week(At baseline and 8-week follow-up)
- White blood cell(At 8-week follow-up)
- Change from baseline white blood cell at 8-week(At baseline and 8-week follow-up)