Can Intermittent Fasting Mimic the Metabolic and Cardiovascular and Anti-aging Effects of Calorie Restriction?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in HSCRP ( high sensitivity C-reactive protein) at 6 and 12 months
研究概览
简要总结
The purpose of Intermittent Fasting study is to investigate whether intermittent fasting could decrease the chronic inflammation levels in overweight/obese people.
详细描述
The primary objective of this study is to determine whether or not IF reduces the level of chronic inflammation as evidenced by a decrease in high sensitive C-reactive protein (hsCRP), as the main outcome measure
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- 是
入选标准
- •The participants in this study will be 50 men and women in the 30 to 65 year age range, who have a BMI in the high normal to moderately obese range (i.e. 24 to 35 kg/m2),
- •Participants who are eating usual US diets and are sedentary to moderately active (i.e. not exercise trained).
排除标准
- •History of any chronic disease process that could interfere with interpretation of results
- •Smoking, pregnancy, alcoholism, psychiatric problems, life situations that would interfere with study participation and compliance.
研究组 & 干预措施
Control group
The participants randomized to the crossover group begin study participation as a control group (no changes in food intake) for the first 6 months and switch to IF for the remaining 6 months of the study.
干预措施: control group (Other)
Intermittent Fasting group
Participant with a BMI between 28 and 35 kg/m2 will fast 3 non-consecutive days per week, whereas participant with a BMI between 24 and 27.9 kg/m2 will fast 2 non-consecutive days per week. Individuals following intermittent fasting (IF) will work with the study dietitian to design their weekly meal plans and menus for the non-fasting days. The subjects following IF will be asked to skip breakfast, lunch, dinner, snacks, and calorie-containing beverages on the fast days, but we will give them the option to consume at dinner a big salad (i.e. non-starchy raw and/or cooked vegetables dressed with 2 tablespoons of salad dressing prepared with vegetable oil, vinegar and seasonings).
干预措施: Intermittent Fasting group (Other)
结局指标
主要结局
Change in HSCRP ( high sensitivity C-reactive protein) at 6 and 12 months
时间窗: Every 6 months- baseline, 6 month and 12 month
HSCRP would be measured in mg/L
次要结局
未报告次要终点