Prospective Interventional Study of the Impact of 3-step Diet With Complimentary Exercise Program
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Weight reduction
研究概览
简要总结
The scientific literature shows a quantitative relationship between diet combined with physical activity as a long term weight reduction modality and an important factor in weight maintenance.
Primary assumption - the 14/21 diet will have an impact on BMI values, and their long-term maintenance.
Secondary assumption - the 14/21 diet will have a positive impact on anthropomorphic and biochemical markers, on blood pressure, resting heart rate, RMR, and life quality.
详细描述
An interventional part for a duration of 56 days and a follow-up period including monitoring of different parameters. Follow up session are set to 3, 6, 12 and 24 months from the end of the interventional period.
Participants will be recruited in several rounds, each including up to 25 participants. Diet program is divided into 3 periods: 1. Low carb diet for 14 days; 2. Low carb and regular diet in alternating days for 21 days; 3. Individual carbohydrate-rich diet for 21 days.
The diet consists of a free choice of food ingredients from a detailed list of foods in each category (proteins, carbohydrates, vegetables, fat etc.). The participants are free to choose the types of food as long as they are within the specified allowance (quantity) for each food group.During the intervention period subjects will meet for walking. In addition, 30 minutes of aerobic exercise will be recommended 3 times/week.
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
- •Hebrew speaking 25<BMI<30 18 years old or older signed an informed consent
排除标准
- •Subjects who have a physical disability preventing them from exercise, Subjects who are pregnant or lactating, Subjects who are currently involved in another lifestyle intervention program, Subjects who had undergone bariatric surgery in the past, Subjects with: cancer, liver/kidney disease, organ transplantation, alcohol/drug addiction, Subjects that have cognitive deterioration or psychosis, vegetarians who does't eat fish/sea food or vegans
结局指标
主要结局
Weight reduction
时间窗: 2 years
BMI will be calculated by the equation weight divided by square height.
次要结局
- Anthropometric measurements(2 years)
研究者
Prof. Sh.Shemer
chairman of the board
Assuta Hospital Systems