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临床试验/NCT03051425
NCT03051425已完成不适用

Immune Benefits of Consumption of Dairy Yogurt Containing Functional Probiotics Among Individuals Over 60 Years Old

Yonsei University2 个研究点 分布在 2 个国家目标入组 200 人开始时间: 2016年3月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
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 consuming dairy yogurt on immun function including natural killer (NK) cell activity, circulating levels of cytokines, and immunoglobulin (Ig) in elderly.

详细描述

A randomized, open-labelled, placebo-controlled study was conducted on 200 nondiabetic, nonobese and elderly (≥60 years) subjects. Over a twelve-week period, the test group consumed one bottle (120 mL) of dairy yogurt each day, whereas the placebo group consumed same volume of low fat milk daily. 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, 1.25:1 or 0.625:1. In addition, cytokines and immunoglobulin levels measured using commercial kits as manufacturer's instruction.

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
None

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Able to give informed consent
  • Over 60 years old without any health problems
  • The levels of white blood cells within range 4x10^3/μL~10x10^3/μL

排除标准

  • Individuals who get a cold
  • Hypersensitivity or disease history for milk protein
  • Epilepsy, neurological, or psychological disease
  • Alcoholism or drug addiction
  • Liver disease or severe kidney failure disease
  • Inflammation-related disease
  • Consumption of other test products or drugs within 1 month prior to screening
  • Regular consumption of immune-related functional foods including yogurt or milk within 1 month prior to screening
  • History of inflammation-related disease or taking medication to treat inflammation-related disease within 1 month prior to screening
  • History of cancer within 5 years
  • Any inappropriate condition

结局指标

主要结局

Natural killer cell activity

时间窗: At 12-week follow-up

Change from baseline natural killer cell activity at 12-week

时间窗: At baseline and 12-week follow-up

次要结局

  • Interleukin-12(At 12-week follow-up)
  • Change from baseline immunoglobulin at 12-week(At baseline and 12-week follow-up)
  • Interferon-gamma(At 12-week follow-up)
  • White blood cell(At 12-week follow-up)
  • Change from baseline Interferon-gamma at 12-week(At baseline and 12-week follow-up)
  • Change from baseline white blood cell at 12-week(At baseline and 12-week follow-up)
  • Change from baseline Interleukin-12 at 12-week(At baseline and 12-week follow-up)
  • Immunoglobulin(At 12-week follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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