NCT06780007已完成不适用
Effect of Akkermansia Muciniphila Akk11 on Weight Loss in Obese Patients: a Multicenter, Randomized, Double-blind, Placebo-controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Change in Body Mass Index(BMI)
研究概览
简要总结
This study intends to study the effect of Akkermansia muciniphila on weight loss and the improvement of blood inflammation and metabolic indexes in obese patients with low Body Mass Index (BMI) through multi-center clinical studies, and for the first time to innovatively explore the weight loss mechanism of Akkermansia muciniphila by comparing the changes in brain function and fecal microbiota before and after intervention.
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(participant, 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
- 是
入选标准
- •1) Age 18-65 years old; 2）28≤BMI≤35Kg/m2； 3) Willing and able to comply with the protocol during the study period, and be able to cooperate with the completion of various examinations during the trial. Written informed consent is provided prior to entry into study screening, and the patient has understood that the study can be withdrawn at any time from the study without any loss
排除标准
- •Pregnant or lactating women, in the reproductive period and not taking contraceptive measures;
- •Oral antibiotics in the past 1 month prior to enrollment;
- •No use of probiotic prebiotic products before 3 weeks of intervention;
- •people without a fitness fat loss program or history of gastric surgery during the intervention period;
- •Patients with severe gastrointestinal diseases;
- •Those who are known to be allergic to synbiotics or similar products;
- •Patients with no self-awareness and those with mental abnormalities;
- •Have a history of organ transplantation or malignant tumor disease;
- •Concurrent use of other experimental drugs or in other clinical trials;
- •Have a history of alcohol, tobacco and other drug abuse;
- •Those who are expected to be unable to complete the magnetic resonance examination;
- •Combined with serious medical diseases or conditions: such as clinically serious (i.e., active) cardiac disease, severe, uncontrolled medical diseases and infections, severe uncontrollable digestive disorders, severe electrolyte disorders, active disseminated intravascular coagulation, major organ failure, such as decompensated heart, pulmonary, hepatic, renal failure, peripheral neuropathy symptoms, etc.
结局指标
主要结局
Change in Body Mass Index(BMI)
时间窗: Day 0, week4, week8, week12.
BMI = Weight (kg) / \[Height (m)\]². 24kg/m² ≤ BMI \< 28 kg/m² is in the overweight range, and BMI ≥ 28 kg/m² is in the obesity range.
次要结局
未报告次要终点
研究者
研究点 (1)
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