Effects of Liquorice on Salivary Cortisol and Cortisone
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Late night salivary cortisol
研究概览
简要总结
Salivary cortisol is used as a diagnostic analysis in the investigation of suspected Cushings' syndrome. This study evaluates if liqourice intake increases salivary cortisol in healthy individuals. Late night salivary cortisol and cortisone is analysed before, during and after 7 days of liqourice intake in three different doses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women 18-65 years.
排除标准
- •Known pituitary or adrenal disease
- •Medication with glucocorticoids (incl. inhalation, nasal, dermal)
- •Known hypertension or blood pressure >140/90 at screening
- •tobacco use
- •Subjective problems in oral mucosa or saliva
- •Abnormal diurnal rhythm (awake 03:00 - 05:30)
- •Difficulties taking liqourice for 3 weeks or refraining from liqourice during 4 weeks
研究组 & 干预措施
glycyrrhizic acid 1.5 mg/kg body weight
Liqourice corresponding to 1.5 mg glycyrrhizic acid per kg body weight is taken in the evening during 7 days.
干预措施: Liqourice (Dietary Supplement)
glycyrrhizic acid 3.0 mg/kg body weight
Liqourice corresponding to 3.0 mg glycyrrhizic acid per kg body weight is taken in the evening during 7 days.
干预措施: Liqourice (Dietary Supplement)
glycyrrhizic acid 6.0 mg/kg body weight
Liqourice corresponding to 6.0 mg glycyrrhizic acid per kg body weight is taken in the evening during 7 days.
干预措施: Liqourice (Dietary Supplement)
结局指标
主要结局
Late night salivary cortisol
时间窗: day 1 to day 7 during liqourice intake
Significantly increased salivary cortisol 23:00 PM compared to baseline (i.e. before start of liqourice intake).
Time to normalization of late night salivary cortisol
时间窗: 1-28 days efter liqourice intake is stopped
Time from liqourice intake is stopped until significant increase of late night salivary cortisol from baseline (i.e. assuming outcome 1 is significant increase) is no longer significant.
次要结局
- Morning salivary cortisol(day 1-2 during liqourice intake)
- Time to normalization of late night salivary cortisol/cortisone ratio(1-28 days efter liqourice intake is stopped)
- Late night salivary cortisol/cortisone ratio(day 1 to day 7 during liqourice intake)