Dose Response Study of the Impact of a Yogurt Containing Bifidobacterium Lactis BB-12 and Lactobacillus Acidophilus LA-5 on the Immune System and Gut Health.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Phagocytosis activity and oxidative metabolism in phagocytes.
研究概览
简要总结
The purpose of this study is to determine the dose-response effect of a yogurt containing a combination of bifidobacterium Lactis (BB-12) and Lactobacillus Acidophilus (LA-5) and green tea extract on markers of the immune system and gut health in healthy subjects. We hypothesize that the response of the immune function will be dose-dependent of the probiotics found in the fermented yogurt.
详细描述
There is an increasing list of food containing probiotics on the market. Several studies have emphasized the health benefits of single probiotics, particularly on the immune system. However, it is unclear how a combination of two different probiotics complemented with green tea extract can beneficially modify markers of the immune.
The aim of this study is to determine the dose-response effect of a yogurt containing a combination of bifidobacterium lactis (BB-12) and Lactobacillus Acidophilus LA-5 and green tea extract on immune system in healthy subjects. More specifically, this randomized, parallel placebo controlled study will investigate the impact of increasing doses (109 and 1010) of these probiotics on phagocytosis activity, oxidative metabolism and on the antipneumococcics antibody specific serotype response S. pneumoniae vaccination. Finally, this study will also examine the effect of increasing dose of these probiotics on intestinal microflora and blood lipids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 to 55 years
- •Healthy individuals, non-smokers
- •BMI between 18 and 35 kg/m2
- •Stable weight (+/- 5kg) for 3 months before randomisation
- •Agree to receive a vaccine Pneumovax 23®
排除标准
- •Pregnant or lactating woman
- •Previous history of cardiovascular disease
- •Kidney or liver disease
- •Gastrointestinal disorders or diseases
- •Endocrine disorders or diseases
- •Subjects taking hypolipidemic drugs, antidepressant, medication for high blood pressure, for inflammation or auto-immune diseases.
- •Subject who have receive antipneumococcics vaccine in the year before randomisation.
研究组 & 干预措施
1
L.acidophilus and B.lactis (1x10E9 of each probiotics) with 40 mg of green the extract
干预措施: Yogurt with 1X10E9 BB-12 and LA-5 (Dietary Supplement)
2
L.acidophilus and B.lactis (1x 10E10 of each probiotics) with 40 mg of green tea extract
干预措施: Yogurt with 1X10E10 BB-12 and LA-5 (Dietary Supplement)
3
Placebo
干预措施: Yogurt Placebo (Dietary Supplement)
结局指标
主要结局
Phagocytosis activity and oxidative metabolism in phagocytes.
时间窗: 6 weeks after vaccination
次要结局
- antipneumococcics antibody specific serotype response to S. pneumoniae vaccination.(6 weeks after yogurt consumption and vaccination)
- Intestinal microflora characteristics.(4 weeks after yogurt consumption)
- Influence of blood lipids.(After 4 weeks and 10 weeks of yogurt consumption)