Efficacy of Balanced Nutrition Meal Replacement Along With a Caloric Restriction on Body Weight Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Anthropometric parameter
研究概览
简要总结
The present study was designed to evaluate the impact of a nutritionally balanced conventional meal replacement diet with caloric restriction (intervention for 8 weeks) in Taiwanese obese subjects. Various parameters like anthropometric (body weight, body fat, waist circumference), lipid profile (TC, LDL-c and TG), cardiovascular risk factors, glycemic and oxidative markers as well as renal and hepatic markers were evaluated.
详细描述
The present study was designed to evaluate the impact of a nutritionally balanced conventional meal replacement diet (rich in soy/pea protein and soluble fibers) with caloric restriction in Taiwanese obese subjects. Obese subjects (BMI>27; n=50, male 23, female 27) were recruited and requested to replace two meals/day (breakfast and lunch or dinner) by balanced nutritional meal replacement diet (equal to 240 kcal) for 8 weeks with one regular meal and make sure the daily target calorie limit should be less than 1500 kcal/day for men and 1200 kcal/day for women.
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
盲法说明
it's a Open-label clinical trial
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy obese subject (BMI >27)
- •Aged between 20 to 80 of both genders with a desire to lose weight.
排除标准
- •Subjects with cancer
- •Hyperglycemic (diabetic)
- •Hypertension,
- •Renal dysfunction
- •Cardiac or hepatic dysfunctio
- •allergic to the dairy product and eating disorders
- •Pregnancy, nursing (lactating), chain smokers and heavy alcoholic subjects
研究组 & 干预措施
Meal replacement diet
Obese subjects (BMI>27; n=50, male 23, female 27) were requested to replace (intervention) two meals/day (breakfast and lunch or dinner) by balanced nutritional meal replacement diet (equal to 240 kcal) for 8 weeks
干预措施: Meal replacement diet (Dietary Supplement)
结局指标
主要结局
Anthropometric parameter
时间窗: 8 Weeks
Intervention with calorie restricted meal replacement diet for 8 weeks to check the change in BMI (Kg/m2)
Cardiovascular (CV) risk factors
时间窗: 8 Weeks
Intervention with calorie restricted meal replacement diet for 8 weeks to check the changes in CV risk factor like Homocysteine (umol/L)
Glycemic markers
时间窗: 8 Weeks
Intervention with calorie restricted meal replacement diet for 8 weeks to check the changes in Glycemic marker like FBG (mg/dL)
Lipid profile
时间窗: 8 weeks
Intervention with calorie restricted meal replacement diet for 8 weeks to check the changes in total cholesterol (mg/dl)
Calorie intake in obese subjects
时间窗: 8 weeks
Intervention with calorie restricted meal replacement diet for 8 weeks to check the changes in calories (Kcal)
次要结局
未报告次要终点
研究者
Chin Kun Wang
Professor
Chung Shan Medical University