A Randomized, Double-blind, Controlled Trial to Evaluate the Efficacy on Overweight With Oral Supplemenation of Probiotics and Prebiotics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Change of Weight
研究概览
简要总结
The goal of this interventional study is to evaluate the efficacy of probiotics with prebiotics on overweight.
200 eligible participants with overweight will be enrolled and randomized to consume four study products for 3 months.
Reseachers will compare the four groups to evaluate whether there is significant improvement on overweight for participants in the study product of probiotics with prebiotics.
详细描述
This study is a multi-center, four arms, randomized, double-blind controlled trial. 200 Eligible participants of 25 to 45 years old with overweight will be randomized in four equal size groups to receive one of the four products of probiotics with and without prebiotics and consume one bottle once in a day for 3 months. All participants will visit the study site for 3 times, once a month, all relevant clinical data will be captured, and recorded in to CTMS (Clinical Trial Management System). Data will be analyzed and reported after the completion of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Chinese males or females, age between 25-45;
- •Overweight population: BMI 24-27.9;
- •Blood lipids in high potential risks but without medication; TG > 5mol/L, LDL >= 3.4 mmol/L, TC >= 5.2 mmol/L.
- •Understand the test procedure, read, and sign an appropriate Informed Consent Form indicating their willingness to participate;
- •Agree to avoid medication treatment for weight management, including blood lipids and sugar control.
排除标准
- •Have used any medication for weight management at least one month before this study.
- •Subject having done plastic surgery for weight management.
- •Be involved in any aspect of test administration, i.e., evaluating or overseeing activities related to product.
- •Have participated in any clinical study involving the test sites within the previous 6 months, or is subject participating in any clinical study concurrently.
- •Have a history of any type of metabolic syndrome, including but not limited to any type of diabetes, obesity and heart disease.
- •Have a history of any disease or the presence of health condition on the study sites that the Investigator feels would interfere with the study.
- •Be taking antihistamines (> 3x/week) or anti-inflammatory (> 8x/week) on a regular basis, or has the subject taken systemic or topical steroidal medications within 4 weeks of study enrollment.
- •Have any of the following conditions or factors that the investigator believes may affect the response of the skin or the interpretation of the test results, including, but not limited to, pregnancy, lactation and hepatitis.
- •Have any cuts/abrasions on the test site at baseline.
- •The subject is an employee of sponsor or the site conducting the study.
结局指标
主要结局
Change of Weight
时间窗: baseline day 0, day 60
Change of Weight in Kg by Inbody S10 from baseline to 2 months
次要结局
- Blood lipids - Total Cholesterol Level(baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90)
- Blood Hormone - Adiponectin Level(baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90)
- Blood inflammation(baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90)
- Feces SCFA(baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90)
- Liver function test(baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90)
- Blood Sugar Level(baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90)
- Blood Hormone - Leptin Level(baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90)
- Feces sIgA(baseline day 0, visit 1 day 30, visit 2 day 60, visit 3 day 90)