Weight Loss Effect on Circulating Levels of Liver Enzymes in Overweight Subjects With High Visceral Fat Area: 12-week Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Serum fatty acid levels (Relative peak area)
研究概览
简要总结
To investigate weight loss effect with mild calorie restriction on circulating levels of liver enzymes in nondiabetic and overweight subjects with high visceral fat area [visceral fat area (VFA) at L4 ≥ 100 cm²].
详细描述
A 12-week randomized, placebo-controlled study was conducted on 80 nondiabetic and overweight subjects with high VFA. The participants divided into two groups: 12-week mild calorie restriction (a 300 kcal/day intake reduction, n=40) or no treatment (control, n=40). The randomization was according to computer-generated block randomization (placebo:test = 1:1). Before and after intervention period, venous blood samples were obtained from the subjects, and biochemical parameters including circulating liver enzymes were measured.
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
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to give informed consent
- •20-60 years old
- •Males and females
- •Overweight (25.0 kg/m²≤ BMI <30 kg/m²)
- •Absence of pregnancy or breast-feeding
- •Stable body weight (body weight change <1kg for 3 months before screening)
- •High visceral fat (VFA) at L4 (VFA at L4 ≥100 cm²)
- •Without hypertension, type 2 diabetes, cardiovascular disease, or thyroid disease
- •No use medication affecting body weight, energy expenditure, or glucose control for the last 6 months
排除标准
- •Prior history of Cushing syndrome or malignancy
- •Prior history of liver disease including chronic viral hepatitis, autoimmune hepatitis, primary biliary cirrhosis, or drug-induced liver disease
- •Excess alcohol intake (based on WHO standard)
- •History of intentional reduction in weight in the preceding 6 months
结局指标
主要结局
Serum fatty acid levels (Relative peak area)
时间窗: At 12-week follow-up
Change from baseline visceral fat area at L4 at 12-week (CT)
时间窗: At baseline and 12-week follow-up
Visceral fat area at L4 (CT)
时间窗: At 12-week follow-up
次要结局
- Fat mass (DEXA)(At 12-week follow-up)
- Fat percentage (DEXA)(At 12-week follow-up)
- Change from baseline fat percentage at 12-week (DEXA)(At baseline and 12-week follow-up)
- Change from baseline fat mass at 12-week (DEXA)(At baseline and 12-week follow-up)