Prospective, Randomized, Double-blind Parallel Group Nutritional Study to Evaluate the Effects of Routine Intake of Fresh vs- Pasteurized Yoghurt on the Immune System in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 125
- 主要终点
- T-cells
研究概览
简要总结
In this study, the purpose was to describe and compare the modulator effects on the immune system of the routine ingestion of fresh vs. pasteurized yoghurt. A unicentral, prospective, randomized, double-blind, parallel group nutritional study for 8 weeks was carried out comparing the ingestion of 125 g (three times a day) of the products in healthy adults. A complete battery of in vitro tests on the activity of immune system, processes and phenomena was performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Care Provider)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Pasteurised yoghurt
干预措施: Pasteurised yoghurt (Other)
Fresh natural yoghurt
干预措施: Fresh yoghurt (Other)
Sterilised yoghurt
干预措施: Sterilised yoghurt (Other)
结局指标
主要结局
T-cells
时间窗: Up to 6 weeks
T-cells measured as percentage of CD3 positive cells among the blood lymphocytes (defined by gating as CD45 bright and low cellular complexity or side scatter)
IFN-gamma induction
时间窗: Up to 6 weeks
T-lymphocyte function: stimulation with PHA and measurement of Intracellular synthesis of IFN-γ in terms of percentage of IFN producing cells among the CD3 CD4 double positive (T helper cells)
IgG
时间窗: Up to 6 weeks
serum IgG concentration measured in mg/dl
次要结局
未报告次要终点
研究者
Alfredo Corell
Proffesor
University of Seville