Licorice and Home Blood Pressure: a Randomized Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Diastolic home blood pressure (mmHg)
研究概览
简要总结
Out-of-office blood pressure is more strongly associated with cardiovascular risk than office blood pressure. Licorice is known to raise blood pressure, but no previous studies have measured the effects on home blood pressure. The aim of this study is to analyze the association between licorice intake and home blood pressure.
详细描述
Healthy volunteers will be invited to participate in a randomized, non-blinded, cross-over study. Participants will be randomized to either of two groups with a 1:1 allocation ratio, stratified by sex. Intervention will be sweet licorice and control will be salty licorice. A run-in period of 1 week will be followed by a 2-week intervention/control, a 2-week washout period, another 2-week control/intervention period and again a 2-week washout period. Home blood pressure will be measured continuously, and blood samples (including potassium and aldosterone) will be collected every two weeks. Analyses will be made comparing baseline characteristics of the two groups, intervention/control and washout period results of the two groups to look for potential carry-over effects, and finally comparing intervention and washout period results respectively to the baseline data to look for the effects of licorice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 30 years
排除标准
- •known hypertension, cardiovascular disease, kidney disease, liver disease, hormonal disease, peanut allergy, eating disorder or headache disease (including tension headache and migraine)
- •known alcohol abuse or drug abuse (including cannabis and anabolic steroids)
- •treatment with hormonal drugs (including oral contraceptives
- •known intolerance to licorice intake
结局指标
主要结局
Diastolic home blood pressure (mmHg)
时间窗: Mean at the end of 14 days of intervention compared with mean during run-in period
Diastolic home blood pressure (mmHg)
Systolic home blood pressure (mmHg)
时间窗: Mean at the end of 14 days of intervention compared with mean during run-in period
Systolic home blood pressure (mmHg)
次要结局
- Plasma sodium (mmol/L)(Mean at the end of 14 days of intervention compared with mean during run-in period)
- Plasma renin (mIU/L)(Mean at the end of 14 days of intervention compared with mean during run-in period)
- Serum aldosterone (μmol/L)(Mean at the end of 14 days of intervention compared with mean during run-in period)
- Plasma potassium (mmol/L)(Mean at the end of 14 days of intervention compared with mean during run-in period)
- Body weight (kg)(Mean at the end of 14 days of intervention compared with mean during run-in period)
研究者
Peder af Geijerstam
Principal investigator
Linkoeping University