Three Arms, Randomized, Double-blind Controlled Trial Of Prevention And Treatment On Obesity And Weight Management By Oral Supplementation 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
- 150
- 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 test whether consumption of Wonderlab probiotics with prebiotics could improve obesity and overweight in Chinese people who are aged 25-45 and overweight. The main question it aims to answer is:
- whether the weight of participants can be lost after 10 weeks' intervention
150 participants will be randomized into 3 study groups (50 each group) in the two study sites, who will consume assigned product according to instructions for 10 weeks. Three site visits will be made for each participant and all relevant clinical data will be captured and recorded into CTMS(Clinical Trial Management System) for statistical analysis.
Researchers will compare the three groups to conclude whether the Wonderlab study product can improve obesity and overweight over placebo product.
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 & obesity population: BMI >=28;
- •Blood lipids in high potential risks but without medication:TG > 5mmol/L or LDL >= 3.4 mmol/L or 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 enrolment.
- •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.
研究组 & 干预措施
Study product A (Wonderlab wonder4shape)
2g/bottle, containing the following probiotics total dosage 2.0*1010 CFU:
- CECT7527, CECT7528, CECT7529
- Maltodextrin
- Lactobacillus acidophilus
- Fructose oligosaccharides
- Grapefruit, Lemon and Apple powder
干预措施: Study product A (Wonderlab wonder4shape) (Dietary Supplement)
Study product B (Wonderlab wonder4shape)
2g/bottle, containing the following probiotics total dosage 1.0*1010 CFU:
- Maltodextrin
- Lactobacillus acidophilus
干预措施: Study product B (Wonderlab wonder4shape) (Dietary Supplement)
Study product C (placebo)
2g/bottle, containing the following ingredients:
- Maltodextrin
- Grapefruit powder
- Lemon powder
干预措施: Study product C (placebo) (Dietary Supplement)
结局指标
主要结局
Change of Weight
时间窗: baseline day 0, day 70
Change of Weight in Kg by Inbody S10 from baseline to 10 weeks
次要结局
- Blood hormone - Leptin level(baseline day 0, day 35, day 70)
- Blood lipids - Total Cholesterol Level(baseline day 0, day 35, day 70)
- Blood Sugar Level(baseline day 0, day 35, day 70)
- Blood inflammation(baseline day 0, day 35, day 70)
- Blood hormone - Adiponectin level(baseline day 0, day 35, day 70)