The CardioDiet Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 1,200
- 试验地点
- 2
- 主要终点
- Diabetes incidence
研究概览
简要总结
This is a multi-centre, open, randomised study in patients treated for ischemic heart disease in Linköping, Norrköping and Jönköping hospitals. One thousand two hundred patients who are treated at the cardiac rehabilitation units will be consecutively recruited during three years. The patients will be randomised 1:1 to be given advice on a 1) Mediterranean diet with an energy content (E%) from carbohydrates between 25-30% or to 2) a traditional low-fat diet with 45-60 E% from carbohydrates. All eligible patients will be asked if they want to participate and provided with written information about the study when they are discharged from the hospital after treatment for ischemic heart disease. The decision to participate or not will be given at the following outpatient treatment at the cardiac rehabilitation unit. When the signed informed consent to participate in the study has been provided, the patient will be randomised to advice of either of the two dietary regimes.
详细描述
Aim To compare advice on a Mediterranean diet with an energy content (E%) from carbohydrates between 25-30 E% with a traditional low-fat diet with 45-60 E% from carbohydrates.
Primary outcome Incidence of diabetes in non-diabetic patients or glycaemic control in patients with known diabetes.
Secondary outcome Recurrence of cardiovascular disease, blood lipid levels, quality of life by questionnaires.
Study design and study population This is a multi-centre, open, randomised study in patients treated for ischemic heart disease in Linköping, Norrköping and Jönköping hospitals. One thousand two hundred patients who are treated at the cardiac rehabilitation units will be consecutively recruited during three years. The patients will be randomised 1:1 to be given advice on a 1) Mediterranean diet with an energy content (E%) from carbohydrates between 25-30% or to 2) a traditional low-fat diet with 45-60 E% from carbohydrates. All eligible patients will be asked if they want to participate and provided with written information about the study when they are discharged from the hospital after treatment for ischemic heart disease. The decision to participate or not will be given at the following outpatient treatment at the cardiac rehabilitation unit. When the signed informed consent to participate in the study has been provided, the patient will be randomised to advice of either of the two dietary regimes.
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
- •Patients treated for ischemic heart disease who are followed up at the cardiac rehabilitation units
排除标准
- •Inability to affect food choice. Severe concomitant disease such as malignancy, renal failure, heart failure or psychiatric disease.
研究组 & 干预措施
Traditional low-fat diet advice
Advice on traditional low-fat diet by dietician
干预措施: Advice on what food to choose and eat (Behavioral)
Mediterranean diet advice
Advice on a Mediterranean dietary regime with reduced carbohydrates
干预措施: Advice on what food to choose and eat (Behavioral)
结局指标
主要结局
Diabetes incidence
时间窗: 3 years
Hba1c \> 48 mmol/mol
次要结局
- Cardiovascular disease(3 years and more)
- Quality of Life(3 years)
研究者
Fredrik H Nystrom
Professor, MD
University Hospital, Linkoeping