Effect of Low-Carbohydrate or Restricted-Calories Diet on Body Weight
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- weight
研究概览
简要总结
- The primary aim of this study is to determine the adherence of low- carbohydrate among Chinese.
- Then compare the effect of low-carbohydrate and traditional Chinese but restricted-calories diet on weight loss and metabolic traits.
详细描述
Obesity is a well established risk factor for type 2 diabetes mellitus, hypertension, dyslipidemia and cardiovascular disease. Along with rapid nutritional and lifestyle transition featured as increased energy dense diet intake and reduced physical activity, the prevalence of obesity has reached epidemic level and affected more than 70 million Chinese adults nowadays. Previous studies suggested that low-carbohydrate diet was an effective and safe way to lose weight and had potential benefit on lipids profiles. However, it is still unknown whether this diet can be feasible to control the epidemic of obesity and its related metabolic diseases among Chinese, whose carbohydrate consumption contribute approximately 55% of total energy intake.
Therefore, the aim of this pilot study is to investigate the adherence and effectiveness of two weight-loss diets among Chinese. This will be a randomized, controlled clinical trial. A total of 50 overweight or obese nurse assistants will be randomly assigned to receive a low-carbohydrate diet or a traditional high-carbohydrate Chinese but restricted-calories diet for 12 weeks. The adherence of study protocol and effects of the two diets on body weight, waist circumference, body fat, fasting glucose and lipid profile will be evaluated.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •overweight/obese (BMI ≥24 kg/m2)
排除标准
- •Pregnancy or lactation;
- •Serum creatinine and blood urea nitrogen level beyond the clinical reference value;
- •alanine aminotransferase and aspartate aminotransferase beyond the reference levels;
- •Gastrointestinal problems that would prevent them from complying with the specified feeding conditions;
- •Received gastrointestinal surgery (except for appendicitis or hernia);
- •Severer CVD;
- •Active cancer;
- •Mental diseases, epilepsia or using anti-depression drugs;
- •Participating in other scientific studies within 3 months before the study.
结局指标
主要结局
weight
时间窗: 12 weeks
次要结局
- body fat mass(12 weeks)
- waist circumference(12 weeks)
- body mass index(12 weeks)
- fast glucose(12 weeks)
- total cholesterol(12 weeks)
- triglyceride(12 weeks)
- LDL-C(12 weeks)
- HDL-C(12 weeks)
- blood pressure(12 weeks)
- urinary ketone(12 weeks)
研究者
Xu Lin
Principal Investigator
Chinese Academy of Sciences