The Effects of Supplementation of Conjugated Linoleic Acid on Body Fat Reduction in Overweight or Obesity Chinese Adults During Weight Loss: A Randomized, Double-blinded, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Change of body fat percentage
研究概览
简要总结
This is a double-blinded randomized controlled trial, to evaluate the effectiveness of daily supplementation of 3.2 g CLA on body fat reduction and lipid profile in overweight or obese Chinese adults, during a lifestyle counselling-based weight loss.
详细描述
This will be a parallel randomized, double-blinded, placebo-controlled trial. Sixty-six overweight or obese men and women aged from 18 to 45 years with elevated body fat percentage, who also meet our inclusion and exclusion criteria, will be randomly assigned to: the treatment group, daily supplementation of 3.2 g CLA (Cis-9, trans-11 isomers and trans-10, cis-12 isomers) plus lifestyle counselling weight loss program; or the control group, daily supplementation of sunflower oil. The intervention will include a 3-day run-in phase and 12-week interventional phase. At baseline and the end of the intervention, physical examination including questionnaires, anthropometric measurement, body composition by Dual Energy X-ray Absorptiometry (DXA), biological sample collection will be undertaken. During the invention, regular lifestyle counselling sessions will be delivered, and detailed record will be tracked for all participants to monitor and improve the adherence and safety.
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
- 否
入选标准
- •Body fat percentage ≥ 20% for men, Body fat percentage ≥ 30% for women ; 2) aged from 18 to 45 years old.
排除标准
- •Pregnancy or lactation;
- •Abnormal liver or kidney function indicated by physical examination within 6 months;
- •Gastrointestinal problems that affect the complying with the procedure;
- •Sever cardiovascular disease;
- •Active cancer;
- •Mental diseases, epilepsy or using anti-depression drugs;
- •Using medicine that affect body weight;
- •Participating in other scientific studies within 3 months before the study.
结局指标
主要结局
Change of body fat percentage
时间窗: week 0 and week 12
次要结局
- Change of body mass index(week 0 and week 12)
- Change of triglycerides(week 0 and week 12)
- Change of LDL-cholesterol(week 0 and week 12)
- Change of waist circumference(week 0 and week 12)
- Change of body fat mass(week 0 and week 12)
- Change of blood pressure(week 0 and week 12)
- Change of weight(week 0, week 4, week 8, and week 12)
- Change of total cholesterol(week 0 and week 12)
- Change of HDL-cholesterol(week 0 and week 12)
研究者
Jiaomei Yang
Associate Research Fellow
Health Science Center of Xi'an Jiaotong University