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临床试验/NCT02535663
NCT02535663已完成2 期

Consumption of Dairy Yogurt With Rhamnogalacturonan in Korean Citrus Hallabong Peel Polysaccharide Enhanced Immune Function and Attenuated Inflammatory Response

Yonsei University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2014年6月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
120
试验地点
1
主要终点
serum cytokine concentrations

研究概览

简要总结

To investigate the impact of consumption of dairy yogurt with rhamnogalacturonan (RG) in Korean citrus Hallabong peel polysaccharide on Natural Killer (NK) cell activity and circulating cytokine levels.

详细描述

A randomized, double-blind, placebo-controlled study was conducted on 120 nondiabetic and nonobese subjects. Over an 8 week period, the test group consumed one pack (150ml) of dairy yogurt with 50mg probiotics and 100mg Korean citrus Hallabong peel polysaccharide (60% RG, 20% mono- and di-saccharide, 5% polyphenol) each day, whereas the placebo group consumed the same product without Korean citrus Hallabong peel polysaccharide. NK cell activities (%) were measured based on the ratios of effector cells (E) (peripheral blood mononuclear cell, PBMC) from each participant to Target cell (T) (K562 cells) as 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
Crossover
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
30 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •The levels of white blood cells under 8x10^3/μL
  • •males and females
  • •30-69 years old
  • •nondiabetic and nonobese subjects
  • •able to give informed consent

排除标准

  • •consumption of any probiotic products within 1 month before screening
  • •unstable body weight (body-weight change > 2 kg within 3 months before screening)
  • •history/presence of significant metabolic disease
  • •pregnancy or breast-feeding
  • •acute or chronic infection
  • •liver disease, kidney disease, gastrointestinal disease, or any other acute or chronic disease requiring treatment
  • •subjects taking any drugs or supplements

研究组 & 干预措施

test group

Experimental

Dietary Supplement: RG consumed one pack (150ml) of dairy yogurt containing RG (100mg Korean citrus Hallabong peel polysaccharide) per day for 8 weeks

干预措施: RG (Dietary Supplement)

placebo

Placebo Comparator

Dietary Supplement: placebo consumed one pack (150ml) of dairy yogurt without RG per day for 8 weeks

干预措施: Placebo (Dietary Supplement)

结局指标

主要结局

serum cytokine concentrations

时间窗: change from baseline in RG at 8 weeks

Primary outcome will be tested before and after intervention

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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