Effects of Supplementing the Bifidobacterium Longum BL21 on BMI, Metabolic Indicators, and Gut Microbiota in Overweight/Obese Adults: a Randomized, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Effects of intervention with Bifidobacterium longum BL21 on the gut microbiota in overweight/obese adults
研究概览
简要总结
The goal of this study is to investigate the effects of Bifidobacterium longum subspecies BL21 on BMI, metabolic indicators, and changes in gut microenvironment microbiota in overweight/obese adults.
The blood, urine, and feces samples of the subjects need to be collected at 0,4 and 8 week and promptly tested in the laboratory. During the intervention period, all groups of subjects were required to take the corresponding products daily and record adverse reactions.
详细描述
The goal of this study is to investigate the effects of Bifidobacterium longum subspecies BL21 on BMI, metabolic indicators, and changes in gut microenvironment microbiota in overweight/obese adults. Randomized grouping was used to provide probiotic BL21 or placebo intervention. The total duration of the study is 8 weeks, including 8 weeks (1-8 weeks) of intervention expectations. The subjects were followed up at weeks 2 and 6, and sampled at weeks 0, 4, and 8. After the intervention during the follow-up period, blood, urine, and feces samples of the subjects need to be collected and promptly tested in the laboratory. During the intervention period, all groups of subjects were required to take the corresponding products daily and record adverse reactions.
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 (Investigator)
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
- •Body mass index (BMI) ≥ 24kg/m2 indicates overweight, and BMI ≥ 28kg/m2 indicates obesity;
- •Willing to take the test formulation daily during the study period;
- •Subjects who understand clinical research and commit to complying with research requirements and procedures.
排除标准
- •Patients with serious chronic diseases (heart, liver, kidney, hematopoietic system, tumor and other serious diseases, mental disease and organ surgery history, diabetes, etc.) and complications;
- •Patients with severe allergies and immune deficiencies;
- •Pregnant, breastfeeding, or expectant women during the study period
- •Patients with a clear history of gastrointestinal diseases (ulcers, irritable bowel syndrome, etc.);
- •Have a history of intervention with lipid-lowering drugs or health products within the past 2 months;
- •Individuals who have used antibiotics within the past two weeks;
- •Failure to consume the test sample as required, or failure to follow up on time, resulting in uncertain efficacy
- •Subjects deemed unsuitable by other researchers to participate.
研究组 & 干预措施
Placebo group
Daily administration of placebo for 8 weeks.
干预措施: Probiotics (Dietary Supplement)
Probiotics group
Daily administration of Bifidobacterium Longum BL21 for 8 weeks.
干预措施: Probiotics (Dietary Supplement)
结局指标
主要结局
Effects of intervention with Bifidobacterium longum BL21 on the gut microbiota in overweight/obese adults
时间窗: 0, 4 and 8 week
Take stool for microbial community sequencing
次要结局
- Effects of intervention with Bifidobacterium longum BL21 on the BMI in overweight/obese adults.(0, 4 and 8 week)