Intentional Weight Loss as Treatment in Obese Patients With Ischaemic Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Change in six minute walk test from baseline to week 16 (end of study)
研究概览
简要总结
30 obese moderate-to-severe heart failure patients will be randomized to intervention or control in groups of 5-10 subjects.
All will receive dietetic advice according to randomization and according to the European Heart Association.
Intervention subjects will initiate with 8 weeks low energy diet, 800-1000 kcal/d by formula diet and subsequent four weeks reintroduction to regular foods supplying 1200 kcal/d substituting two daily meals with formula meal replacement.
Control subjects are advised to follow the Nordic Nutrition Recommendations.
Patients will be monitored by blood sampling and assessed by change in physical performance.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •heart failure, moderate to severe, new york heart association II og III
- •stable disease
- •age >18 years
- •out-patients
- •perform a six minutes walk test
- •given consent
排除标准
- •unstable disease
- •insulin treated diabetes
- •pregnancy or lactating
- •unstable weight past 6 months (+- 10 kg)
- •planned procedures in the time of intervention
研究组 & 干预措施
low energy diet
low energy diet treatment
干预措施: Dietetic group sessions (Behavioral)
Nordic recommendation
Nordic recommendation, no restrictions on energy
干预措施: Dietetic group sessions (Behavioral)
结局指标
主要结局
Change in six minute walk test from baseline to week 16 (end of study)
时间窗: weeks 0 and 16
Performance measure
次要结局
- Change in lipid status from baseline to week 16 (end of study).(weeks 0,1,2,4,6,8,10,12,14,16)
研究者
Arne Astrup
Professor
University of Copenhagen