NCT03287726已完成不适用
Evaluation of the Potential Impact of Probiotics on Weight Loss Maintenance in Individuals With Obesity
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- body composition
研究概览
简要总结
Weight loss maintenance is the biggest challenge in obesity management, with the majority of weight-reduced individuals experiencing weight regain. The intake of probiotics has been shown to help in weight loss, but its potential in maximizing weight loss maintenance remains unknown. Therefore, the main aim of this study is to investigate the impact of probiotic consumption on weight loss maintenance. Secondary aims are to investigate if the intake of probiotics influences gut microbiota, cardio-metabolic profile, appetite and inflammatory markers.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •class I or II obesity (30 kg/m2 < BMI > 40 kg/m2)
- •weight stable (<2 kg variation in weight within the last 3 months)
- •not currently dieting to lose weight
- •dietary intervention of 1000 kcal energy restriction for 8 weeks using a powder based low energy diet product, followed by 4 week weight stabilization phase (re-introduction of food)
- •women who are either post-menopausal, taking oral contraceptives or with a normal cycle (28 ± 2 days)
排除标准
- •consumption of probiotics 6 months before taking part in the study
- •breast-feeding
- •drug or alcohol abuse within the last two years
- •currently taking medication known to affect appetite or induce weight loss
- •enrolled in another obesity treatment program
- •history of psychological disorders
- •having had bariatric surgery
- •metabolic diseases (such as hypo/hyperthyroidism and diabetes type 1 or 2)
- •eating disorders
- •lactose intolerance
- •gastrointestinal (particularly cholelithiasis), kidney, liver, lung, cardiovascular disease
- •malignancies
结局指标
主要结局
body composition
时间窗: 9 months
air displacement plethysmography (BodPod, COSMED, Italy)
次要结局
- appetite suppression(9 months)
- resting metabolic rate(9 months)
- body composition(9 months)
研究者
研究点 (1)
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