NL-OMON53237招募中不适用
The effect of citrus extract on sleep and mental wellbeing - Citrus extract, sleep and mental wellbeing
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •men and women, 40-70 years old, BMI 18,5-30 kg/m2, (mild) sleep disturbance
- •(PSQI score >5), willingness to give up being a blood donor from 4 weeks before
- •the start of the study until 4 weeks after completion of the study.
排除标准
- •Excessive caffeine use ( >400 mg/day)
- •Major psychiatric/mental health disorders (e.g. major depression,
- •post-traumatic stress disorder, bipolar disorder, schizophrenia).
- •Chronic sleep disorders (e.g. sleep apnea, restless leg syndrome, periodic
- •limb movement disorder)
- •Severe sleep disturbance for more than 1 year
- •Other clear causes for poor sleep quality, stress, depression or anxiety
- •(e.g. stressful situation or life event, excessive noise, snoring partner,
- •infants/children regularly awakening, shift-work, chronic/acute pain)
- •Use of medication or supplements that can affect outcomes (e.g.
- •anti-depression medication, sleeping pills, melatonin)
- •Use of medication that can be affected by intake of grapefruit (juice)
- •Nonpharmacological treatment for sleep disorders (cognitive behavioural
- •therapy, relaxation therapy)
- •Flight from a time-zone with >3 h difference <=1 week before an intervention
- •Administration of investigational drugs or participation in any scientific
- •intervention study which may interfere with this study, to be decided by the
- •principal investigator, in the 180 days prior to the 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, or intention to lose weight during the study period
- •Abuse of products (> 20 alcoholic consumptions per week and drug usage)
- •Current use of (antioxidant) dietary supplements and not willing to quit for
- •the duration of the study duration
- •Known allergy to citruses
- •Known pregnancy or lactation
研究者
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