Effect of Akkermansia Muciniphila Akk11 on Metabolic and Gut Health in Overweight and Obese Subjects: 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
- 110
- 试验地点
- 1
- 主要终点
- Changes in serum concentrations of leptin before and after intervention.
研究概览
简要总结
To assess the efficacy and safety of the use of probiotics as a food supplement compared to placebo in regulating body metabolism and gut microbiota in overweight or obese subjects.
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)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-45 years old;
- •BMI ≥ 24 kg/m2 or men with a body fat percentage of ≥ 25% and women with a body fat percentage of ≥ 30%；
- •Normal liver function indexes;
- •Willing to complete study-related questionnaires and diaries and complete all clinical visits.
排除标准
- •Those who have been diagnosed with high uric acid or gout are not recommended to participate in the test;
- •Psychiatric or neurological diseases, celiac disease, lactose intolerance, allergies;
- •Have the following diseases: irritable bowel syndrome, ulcerative colitis, fatty liver, liver cirrhosis, etc.;
- •Recently treated with antibiotics (i.e., < 3 months prior to the start of the study);
- •Participants who smoked more than 10 cigarettes per day were excluded;
- •It is not recommended to participate in other special circumstances, such as those who are allergic to probiotic products;
- •Pregnant and lactating women are not suitable for experiments.
研究组 & 干预措施
Placebo group
Each placebo capsule contained 350 mg inulin and 175 mg FOS (2:1 ratio). Dosage: 3 capsules per day.
干预措施: Placebo (Dietary Supplement)
Probiotic group
Each Akk11 capsule contained 350 mg inulin and 175 mg FOS (2:1 ratio), together with 1 × 10¹⁰ AFU of viable Akk11 cells. Dosage: 3 capsules per day.
干预措施: Probiotic (Dietary Supplement)
结局指标
主要结局
Changes in serum concentrations of leptin before and after intervention.
时间窗: week 0 and week 8
Detected by enzyme-linked immunosorbent assay (ELISA).
Changes in serum concentrations of peptide YY before and after intervention.
时间窗: week 0 and week 8
Detected by enzyme-linked immunosorbent assay (ELISA).
Changes in serum concentrations of glucagon-like peptide-1 (GLP-1) before and after intervention.
时间窗: week 0 and week 8
Detected by enzyme-linked immunosorbent assay (ELISA).
次要结局
未报告次要终点