NCT00956566已完成不适用
Randomized Parallel Group Comparison on the Influence of a Low Carbohydrate and a Low Fat Hypocaloric 6 Months Diet on Body Weight Reduction, Metabolic and Cardiovascular Variables in Obese Healthy Women and Men.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Body weight reduction
研究概览
简要总结
The investigators will test the hypothesis that a LOW CARB hypocaloric diet will reduce body weight over six months more than a LOW FAT hypocaloric diet. In addition to body weight, the investigators will measure cardiovascular and metabolic variables and will take blood samples in order to determine whether certain metabolites may predict the diet success.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body Mass Index > 27 kg/m2
- •No chronic medication (except oral contraceptives and L-Thyroxine) or possibility to stop medication for study duration
- •Able to give written informed consent
排除标准
- •Pregnancy and nursing
- •Severe cardiovascular, liver, kidney, hepatic or orthopedic disease that need treatment
- •Metabolic or endocrine disease that need treatment
- •Hypertension blood pressure > 160/95 mmHg or need of > 2 drugs
- •Previous stroke or cerebral ischemia
- •Significant neurologic or psychiatric disease
- •Any kind of eating disorder
- •Bariatric surgery in the past
- •Drug or alcohol abuse
- •Any cancer in the past
- •Acute and chronic infections
- •Metallic implants (e.g. pace makers) or conditions that do not allow MRI scans
- •Body weight > 130 kg
研究组 & 干预措施
Low carbohydrate hypocaloric diet
Active Comparator
干预措施: dietary intervention (Behavioral)
low fat hypocaloric diet
Active Comparator
干预措施: dietary intervention (Behavioral)
结局指标
主要结局
Body weight reduction
时间窗: Month 6
次要结局
- Influence on energy expenditure and fat oxidation rates(Month 6)
- Weight maintenance(Month 12 - 36)
- Reduction of left ventricular mass(Month 6)
- Reduction of visceral adipose tissue mass(Month 6)
研究者
Prof. Dr. Jens Jordan
Prof. Dr. med.
Hannover Medical School
研究点 (2)
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