The Efficacy and Safety of a Probiotic in Reducing Body Fat and Blood Lipids Among Overweight and Obese Individuals
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Effect on body mass index (BMI) values.
研究概览
简要总结
This study aims to investigate the effects of Bifidobacterium breve BBr60 on key health indicators in overweight and obese adults. Specifically, it will assess the probiotic's impact on body composition metrics such as BMI, body fat percentage, WHR, and BMR. The inclusion criteria for participants are a BMI of ≥28 kg/m^2, targeting individuals who stand to benefit significantly from metabolic and body composition improvements.
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 (Participant)
盲法说明
Double（Participant,Investigator）
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) ≥ 28 kg/m2;
- •Voluntarily, in writing, and signing the informed consent form, agreeing to participate in this study;
- •Those who agree to abide by the protocol and study restrictions and are able to comply with a low-carbohydrate, energy-restricted diet plan.
- •Subjects (including male subjects) have no plans to have children from 14 days before screening to 6 months after the end of the trial and voluntarily take effective contraceptive measures;
排除标准
- •Taking items with similar functions to those tested in a short period of time will affect the judgment of the results;
- •Patients with severe allergies and immune deficiency;
- •Women who are pregnant, breastfeeding or planning to become pregnant;
- •Severe diseases of cardiovascular, lungs, liver, kidneys and other important organs, diabetes, thyroid disease, severe metabolic diseases, malignant tumors, and severe immune system diseases;
- •People who have used antibiotics in the past two weeks;
- •Those who failed to consume the test samples as required or failed to follow up on time, resulting in uncertainty in determining the efficacy;
- •Have used laxatives or fiber supplements in the past 6 weeks;
- •Subjects judged by other researchers to be unfit to participate. Those who meet any of the above conditions will not be selected.
结局指标
主要结局
Effect on body mass index (BMI) values.
时间窗: 12 weeks
After the probiotic intervention, the change in body mass index (BMI) from baseline in obese/overweight individuals will be calculated. BMI is measured by dividing a person's weight in kilograms by the square of their height in meters (kg/m\^2).
次要结局
未报告次要终点