Effects of Consumption of a Probiotic Formulation on Weight Control in Obese Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Body weight; Body composition (DEXA); Waist circumference
研究概览
简要总结
Probiotics administration is associated with health benefits on gut barrier integrity and immunological functions of the gastrointestinal tract. Recently, probiotics consumption was proposed to reduce fat mass and body weight in rodents (Lee HY. et al. 2006; Hamad EM. et al. 2009) as well as abdominal fat in human (Kadooka Y, 2010). The mechanisms explaining the effects of probiotics in weight control are not well understood.
The primary objective of the clinical trial is to investigate whether a consumption of a probiotic formula when compared to an intake of a placebo, is associated with a greater reduction of body weight.
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
- Double (Participant, Investigator)
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 and 55 years old
- •Weight: 30.0 kg/m2 ≤ BMI ≤ 39.9 kg/m2
- •Non smokers
- •Good general health
- •A 2 weeks probiotics washout period prior to treatment initiation
排除标准
- •Under antibiotics or treatments (medication or nutritional program) affecting body weight or glucose control for the last 3 months
- •Currently participating or having participated in another clinical trial during the last 6 months prior to the beginning of this study
- •Pregnant women, women who have given birth in the past year, women planning pregnancy in the next 6 months or menopausal women
- •Excessive consumption of products enriched in probiotics (> 4 servings per week).
- •History of drug or alcohol (> 2 drinks daily) abuse
- •Abnormal thyroid hormone levels
- •Intake of medication that could affect body weight and/or energy expenditure
- •Family history of type 2 diabetes in first degree relatives
- •Allergy to the ingredients in the study product and placebo
- •Participant with anaemia
- •Participant with a recent history of large weight fluctuations (e.g., > 10 kg in the past year
- •Immune-compromised conditions
- •Participant experiencing nausea, fever, vomiting, bloody diarrhoea or severe abdominal pain
- •Participant with co-morbidity associated with obesity:
- •Hypertension (≥ 140/90 mm Hg)
- •Current use of antihypertensive medications, depression
- •Prediabetes (fasting glucose >100mg/dL)
- •Family history of premature coronary artery disease
- •LDL > 2.0 mmol/L
- •HDL < 1.3 mmol/L
- •Obstructive sleep apnea
- •Type 2 diabetes
- •Cardiovascular disease.
研究组 & 干预措施
Placebo
daily placebo consumption
干预措施: Placebo (Other)
Probiotic
daily probiotic consumption
干预措施: Probiotic (Other)
结局指标
主要结局
Body weight; Body composition (DEXA); Waist circumference
时间窗: PRE and POST
次要结局
未报告次要终点