Effect of Weizmania Coagulans BC99 Intervention on Gut Microbiota and Metabolic Markers in Overweight/Obese Adults: 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
- The gut microbiota were sequenced by 16s high-throughput sequencing.
研究概览
简要总结
The main purpose of this study is to verify the effects of Weizmania Coagulans BC99 on the gut microbiota and fat related markers (TG, TC, HDL, LDL) in overweight/Obese adult subjects.
The subjects participate were randomly grouped and receive intervention with Weizmann clotting bacteria BC99 or placebo. The total duration of the study is 8 weeks. After the intervention, blood, urine, and feces samples of the subjects need to be collected and promptly tested in the laboratory. During the intervention period, each group of subjects was required to take the corresponding product daily and record complications.
详细描述
The main purpose of this study is to verify the effects of Weizmania Coagulans BC99 on the gut microbiota and fat related markers (TG, TC, HDL, LDL) in overweight/Obese adult subjects.
The subjects participate in the screening on a voluntary basis, and those who pass the screening will enter the trial. Randomly group and receive intervention with Weizmann clotting bacteria BC99 or placebo. The total duration of the study is 8 weeks, including 1 week before the trial (followed up once), 4 weeks during the trial (followed up once a week), and 8 weeks during the trial (followed up once a week). After the intervention, blood, urine, and feces samples of the subjects need to be collected and promptly tested in the laboratory. During the intervention period, each group of subjects was required to take the corresponding product daily and record complications.
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)
盲法说明
double blind
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
- •All patients meet the diagnostic criteria for severe illness, and a body mass index (BMI) of ≥ 24kg/m2 is considered overweight;
- •Age 18-65 years old;
- •Without dieting or weight loss, and able to accept dietary intervention, maintain a low-carbon and healthy diet during the trial period;
- •Patients who understand clinical research and commit to complying with research requirements and procedures;
- •Patients who have signed informed consent forms. Able to complete research according to the requirements of the experimental protocol;
排除标准
- •Taking items with similar functions to the test subjects in the short term can affect the judgment of the results;
- •Have taken antibiotics 2 weeks before recruitment;
- •Those who stop taking the test sample or add other drugs midway, and cannot determine the efficacy or have incomplete information;
- •Obesity caused by drug treatment (hormones, antidepressants, etc.), endocrine diseases, combined with severe liver and kidney dysfunction, water retention or muscle development;
- •Patients who are pregnant, lactating, stomatal, critically ill, or have potential health conditions that affect metabolism or weight;
- •Neuroendocrine system diseases (hypothyroidism, polycystic ovary syndrome, Cushing's syndrome, hypothalamic injury, etc.);
- •Have a clear history of gastrointestinal diseases (such as ulcers, gastrointestinal bleeding, irritable bowel syndrome, celiac disease, inflammatory bowel disease, Crohn's disease, or other diseases) and a history of surgery (such as weight loss surgery, bandaging surgery, gastrointestinal anastomosis surgery, and intestinal resection surgery);
- •Hereditary obesity Hereditary obesity (such as PWS, Down's syndrome), metabolic obesity (such as obesity reproductive impotence syndrome), endocrine obesity (such as Kirschner's syndrome, hypothyroidism), any disease affecting liver fibrosis or steatosis, metabolic disease (such as hypothyroidism/hyperthyroidism, type 1 or type 2 diabetes, etc.);
- •Patients who changed their diet type during the study period;
- •Patients with severe diseases such as cardiovascular, cerebrovascular, liver, kidney, and hematopoietic systems, as well as endocrine diseases, and mental illnesses;
- •According to the researcher's judgment, the condition of the subject does not qualify them to participate in the study.
结局指标
主要结局
The gut microbiota were sequenced by 16s high-throughput sequencing.
时间窗: 0, 4 and 8 week
Verification of the effects of Weizmania Coagulans BC99 on the gut microbiota in overweight adult subjects.
次要结局
- The fat related biomarkers (TG, TC, HDL, LDL) were detected by blood biochemistry.(0, 4 and 8 week)