Health Effects of a Nordic Diet Rich in Plant-based Foods and Fish
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 111
- 试验地点
- 2
- 主要终点
- Change from baseline in systolic and diastolic blood pressure after treatments
研究概览
简要总结
The purpose of this study is to investigate the effects of a Nordic diet rich in plant-based foods and fish on indicators of cardiovascular disease risk at two different levels of salt intake.
The study is a 20-wk randomized controlled crossover trial. The subjects follow a salt-restricted diet during the study. The study begins with a 4-wk run-in phase for all subjects. After that the subjects are randomly allocated to one of two groups. Group 1 consumes a healthy Nordic low-salt diet enriched with plant-based foods and fish for 16 weeks. Group 2 consumes a low-salt diet for 16 weeks. During the 16 weeks, both groups receive salt and placebo capsules in a double-blind, crossover fashion (8+8 weeks).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •prehypertension or hypertension (systolic blood pressure 130-159 mmHg or diastolic blood pressure 85-99 mmHg)
排除标准
- •regular use of medications
- •intestinal disorders
- •symptomatic cardiovascular disease
- •obesity (BMI>35 kg/m2)
- •vegetarianism
- •high intake of alcohol
- •allergy to fish
- •pregnancy
结局指标
主要结局
Change from baseline in systolic and diastolic blood pressure after treatments
时间窗: 12 and 20 weeks
次要结局
- Change from baseline in PFA-100 measurements after treatments(12 and 20 weeks)
- Change from baseline in biomarkers of cardiovascular disease risk after treatments(12 and 20 weeks)
- Change from baseline in nutritional biomarkers after treatments(12 and 20 weeks)
- Change from baseline in blood cell gene expression after treatments(12 and 20 weeks)
研究者
Iris Erlund
PhD., senior researcher
Finnish Institute for Health and Welfare