Probiotics Effect on Glucose and Lipid Metabolism and Gut Microbiota in Patients With Obesity: a Randomized, Double-blind Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- change from baseline in fasting blood-glucose at 1 month
研究概览
简要总结
The purpose of this study is to determine whether the probiotics will be effective in the treatment of obesity
详细描述
This study aims to evaluate the effect of probiotics on the improvement of glucose and lipid metabolism, as well as the gut microbiota.Baseline, 1 month and 3 months data will be collected and put into analysis to provide some suggestions on the probiotics use in the clinical practice for obesity patients.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 15 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 15-60 years
- •BMI≥28.0kg/m2
- •Agree to cooperate in the trial
- •Provision of written informed consent
排除标准
- •With chronic gastrointestinal diseases, severe immune deficiency, lactose intolerance
- •Use antibiotics, bacteriostatic agents (eg berberine), lipid-lowering drugs, antacids, H2 Blockers, proton pump inhibitors, corticosteroids or sex hormones
- •Use any probiotics in the last 3 months
- •Allergic constitution
- •Participating in any other clinical trials
- •Was not able to insist until the end
- •Pregnant and lactating women
结局指标
主要结局
change from baseline in fasting blood-glucose at 1 month
时间窗: 1 month
change of the fasting blood-glucose will be calculated at 1 month in comparison with the baseline
change from baseline in glycosylated hemoglobin change at 3 months
时间窗: 3 months
change of the glycosylated hemoglobin will be calculated at 3 months in comparison with the baseline
change from baseline in fasting blood-glucose at 3 months
时间窗: 3 months
change of the fasting blood-glucose will be calculated at 3 months in comparison with the baseline
change from baseline in glycosylated hemoglobin change at 1 month
时间窗: 1 month
change of the glycosylated hemoglobin will be calculated at 1 month in comparison with the baseline
次要结局
- change from baseline in uric acid at 1 month(1 month)
- change from baseline in uric acid at 3 months(3 months)
- change from baseline in glutamic oxalacetic transaminase at 3 months(3 months)
- change from baseline in cholesterol at 3 months(3 months)
- change from baseline in high-density lipoprotein at 1 month(1 month)
- change from baseline in gut microbiota at 3 months(3 months)
- change from baseline in cholesterol at 1 month(1 month)
- change from baseline in high-density lipoprotein at 3 months(3 months)
- change from baseline in low-density lipoprotein at 3 months(3 months)
- change from baseline in interleukin-6 at 1 month(1 month)
- change from baseline in triglyceride at 1 month(1 month)
- change from baseline in triglyceride at 3 months(3 months)
- change from baseline in low-density lipoprotein at 1 month(1 month)
- change from baseline in C-reactive protein at 3 months(3 months)
- change from baseline in superoxide dismutase at 1 month(1 month)
- change from baseline in tumor necrosis factor-a at 1 month(1 month)
- change from baseline in interleukin-8 at 3 months(3 months)
- change from baseline in c peptide at 3 months(3 months)
- change from baseline in percentage of body fat at 1 month(1 month)
- change from baseline in gut microbiota at 1 month(1 month)
- change from baseline in glutamic oxalacetic transaminase at 1 month(1 month)
- change from baseline in alkaline transaminase at 1 month(1 month)
- change from baseline in alkaline phosphatase at 1 month(1 month)
- change from baseline in interleukin-6 at 3 months(3 months)
- change from baseline in fasting insulin at 3 months(3 months)
- change from baseline in c peptide at 1 month(1 month)
- change from baseline in visceral fat fraction at 3 months(3 months)
- change from baseline in body age at 3 months(3 months)
- change from baseline in alkaline transaminase at 3 months(3 months)
- change from baseline in alkaline phosphatase at 3 months(3 months)
- change from baseline in superoxide dismutase at 3 months(3 months)
- change from baseline in body age at 1 month(1 month)
- change from baseline in C-reactive protein at 1 month(1 month)
- change from baseline in tumor necrosis factor-a at 3 months(3 months)
- change from baseline in interleukin-8 at 1 month(1 month)
- change from baseline in fasting insulin at 1 month(1 month)
- change from baseline in visceral fat fraction at 1 month(1 month)
- change from baseline in percentage of body fat at 3 months(3 months)
研究者
Huanlong Qin
Professor
Shanghai 10th People's Hospital