NCT01066260已完成不适用
Efficacy of a Probiotic Formulation on Energy Balance in Overweight Subjects
Société des Produits Nestlé (SPN)2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2009年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Energy intake
研究概览
简要总结
Probiotic administration is associated with health benefits on gut barrier integrity and immunological functions of the gastrointestinal tract. Recently, probiotic consumption was proposed to reduce fat mass and body weight in rodents (Lee HY. et al. 2006; Hamad EM. et al. 2009). Changes in energy metabolism might be involved in the effects of probiotics on weight control.
The objective of this study was to assess the efficacy of the consumption of a probiotic formulation on energy balance in overweight subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body Masss Index (BMI) 25 - 30 kg/m2
- •Healthy (determined by medical questionnaire)
- •Able to commit to the duration of the study
- •Providing consent for participation
排除标准
- •History of cardiovascular disease (CVD), diabetes, cancer, renal, thyroid or hepatic disease
- •History of gastrointestinal surgery
- •History of sleep disorders
- •Recent bacterial infection (< 2 weeks)
- •Weight loss > 5 kg in the last 3 months
- •Under antibiotics or treatments (medical or nutritional program) affecting body weight, appetite, energy expenditure lipid-lowering, hypertension or inflammation or glucose control for the last 3 months or taking hormone replacement therapy
- •Excessive consumption of products enriched in probiotics (> 4 servings per week) within the last 4 weeks before the start of the study
- •History of drug or alcohol abuse (> 2 drinks daily)
- •Regular smokers (more than 5 cigarettes a day)
- •Not eating breakfast regularly or eating breakfast before 6h
- •Not willing to eat any of the foods to be served in the study for any reason
- •Physical activity level > 150 min of moderate or intense exercise per week
- •Concurrent or recent intervention study (within 60 days)
结局指标
主要结局
Energy intake
时间窗: Lunch
次要结局
未报告次要终点
研究者
研究点 (2)
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