Effect of a Modified 5:2 Intermittent Fasting Diet on Population With Overweight or Obesity in China: A Self-controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- glycolipid metabolism indicators
研究概览
简要总结
This study aimed to investigate the effects of the modified 5:2 IF dietary intervention on the Chinese population with overweight or obesity based on a self-controlled clinical trial.
详细描述
There are fewer studies on the influence of dietary interventions on the Chinese populations with obesity, and the degree of obesity, body fat distribution, dietary pattern and structure, and metabolic status of populations with obesity are different between the Chinese and European populations. The effects of a 5:2 IF dietary intervention on the Chinese population with overweight or obesity are unclear. Therefore, this study aimed to investigate the effects of the modified 5:2 IF dietary intervention on the Chinese population with overweight or obesity based on a self-controlled clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •participants aged 18 to 60 years
- •participants with a body mass index (BMI) ≥ 24 kg/m2
- •participants engaged in light physical labor and their weight was relatively stable.
排除标准
- •participants taking any medication with an effect on body weight in the three months prior to enrollment;
- •participants with liver or kidney dysfunction (liver enzymes ≥ 2 times normal; blood creatinine > the upper limit of normal);
- •participants with a history of cardiovascular disease (e.g., coronary heart disease, stroke);
- •participants with malignant tumors;
- •women during pregnancy or breastfeeding;
- •participants deemed unsuitable by the investigator to participate in this trial.
研究组 & 干预措施
Modified 5:2 IF diet
The modified 5:2 IF diet involves 2 nonconsecutive fasting days (25%-30% of the total required daily energy intake based on ideal body weight) and 5 days of habitual intake (limited total energy intake according to ideal body weight) per week, as well as a 4-week run-in period and a minimum of 6,000 steps of physical activity per day.
干预措施: A modified 5:2 intermittent fasting diet (Dietary Supplement)
结局指标
主要结局
glycolipid metabolism indicators
时间窗: 24 weeks after intervention
fasting plasma glucose (FPG), fasting plasma insulin (FPI), fasting C-peptide (FCP), triglycerides (TG), total cholesterol (TC), low density lipoprotein-cholesterol (LDL-C), high density lipoprotein-cholesterol (HDL-C), and uric acid.
inflammatory factors before the modified 5:2 IF diet intervention and after 24 weeks of intervention
时间窗: 24 weeks after intervention
high sensitivity C-reactive protein (hsCRP), interleukin 6 (IL-6), and tumor necrosis factor-alpha (TNF-α)
body measurements
时间窗: 24 weeks after intervention
weight, BMI, and waistline
adipokines
时间窗: 24 weeks after intervention
leptin and lipocalin
次要结局
- Change in metabolic components(24 weeks after intervention)
研究者
Xiaoli Wang
Principal Investigator
Zhejiang Provincial Tongde Hospital