Study of the Effects of a Probiotic Yoghourt on the Metabolic Health of Normal Male Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Metabolomic analyses
研究概览
简要总结
The important role played by the GI tract microflora on the metabolic health of an individual are increasingly recognized. In this respect, the initial studies of Metchinkoff that suggested a role of fermented food (specifically yoghourts ) to modulate the gut microflora have evolved into the concept of "probiotics". Probiotics are living microorganisms that bring a benefit to the host when administered in sufficient quantity (WHO/FAO, 2001).
Here the investigators will study, in normal young male volunteers, the potential to modulate post-prandial metabolic and inflammatory responses by the administration of a yoghourt containing the probiotic Lactobacillus rhamnosus (LGG).
详细描述
This is a prospective, randomized, double-blind and cross-over study designed to evaluate the potential of a probiotic (Lactobacillus rhamnosus) to modulate the post prandial metabolic and inflammatory response of normale healthy individuals.
After a wash out period during which volunteers will have to follow a diet devoid of all milk or milk-derived products, they will receive, in random order, either a daily dose of the probiotic, or a daily dose of acidified milk (control) for a total of three consecutive weeks. At the end of each of these period, they will be submitted to a day of investigation, during which their metabolic and inflammatory profile will be studied following the ingestion of a standard test meal. The potential for the probiotic to modulate the metabolic and inflammatory parameters will be evaluated.
The test meal will provide 1004Kcal under the form of 45.4g proteins (17%), 69g total fatty acids (62%), and 52.6g glucids (21%) as previously published (Schwander et al, J Nut 2014).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Normal male with normal BMI (18.5-25 kg/m2)
- •non smoker
- •stable physical activity
排除标准
- •Food intolerance (ceoliac disease, lactose intolerance, food allergies)
- •Particular regimen (vegetarian...)
- •Chronic disease (any)
- •Elevated blood pressure
- •Regular drug treatment
- •Antibiotics treatement in the preceding six months
- •>4 hrs/week of physical activity
结局指标
主要结局
Metabolomic analyses
时间窗: 6 hours
Kinetics of metabolomic changes in blood during the 6 hours after meal ingestion, in presence of yogurt or placebo
次要结局
- Glucose(6 hours)
- Insulin(6 hours)
- Glucagon like polypeptide-1(6 hours)
- Gastric inhibitory polypeptide(6 hours)
- Total cholesterol(6 hours)
- LDL-cholesterol(6 hours)
- HDL-cholesterol(6 hours)
- Non esterified fatty acids(6 hours)
- Triglycerides(6 hours)
- Interleukin-6(6 hours)
- Chemokine CCK2(6 hours)
- Chemokine CCK5(6 hours)
- Tunour necrosis factor alpha(6 hours)
- Lipo-poly-saccharide(6 hours)
研究者
Francois Pralong
Full professor and Head, Service of Endocrinology, Diabetology and Metabolism
Centre Hospitalier Universitaire Vaudois