The Effect of Citrus Extract on Sleep and Mental Wellbeing
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Changes in sleep quality between the intervention and placebo group
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, cross-over trial investigating the effects of daily administration of citrus extract on sleep and mental wellbeing.
详细描述
Based on epidemiological data, a substantial number of people report to have sleeping problems. This is of major concern, as poor sleep quality has been associated with impaired mental and physical health. Several pre-clinical studies have shown promising results, but evidence from human studies is still limited. Therefore, the aim of the present study is to investigate the effect of a citrus extract on sleep and mental wellbeing in healthy subjects with (minor) sleep disturbance.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy individuals with (minor) sleep disturbance
- •Age 40-70 years
- •BMI 18.5 - 30 kg/m2
- •Willingness to give up being a blood donor from 4 weeks before the start of the study, during the study and for 4 weeks after completion of the study
排除标准
- •Excessive caffeine use
- •Major psychiatric/mental health disorders .
- •Chronic sleep disorders
- •Severe sleep disturbance for more than 1 year
- •Other clear causes for poor sleep quality or mental wellbeing
- •Use of medication or supplements that can affect outcomes
- •Nonpharmacological treatment for sleep disorders
- •Flight from a time-zone with >3 h difference ≤1 week before an intervention period
- •Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study
- •Use of pre-, pro- or synbiotics within 1 month prior to the start of the study
- •Reported weight loss or weight gain of >3 kg in the month prior to pre-study screening
- •Abuse of products
- •Known allergy to citruses
- •Known pregnancy or lactation
结局指标
主要结局
Changes in sleep quality between the intervention and placebo group
时间窗: 8 weeks of intervention
Measured using actigraphy
Changes in sleep quality scores between the intervention and placebo group
时间窗: 8 weeks of intervention
Measured by a sleep quality questionnaire (PSQI)
次要结局
- Changes in mental wellbeing between the intervention and placebo group(8 weeks of intervention)