CHRONO-NUTRITION INTERVENTIONS FOR IMPROVING SLEEP QUALITY: The Impact of Last Meal Composition and Timing on Sleep Quality Among Medical Residents at Hospitals
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in Sleep Quality (PSQI Global Score)
研究概览
简要总结
This randomized controlled trial aims to evaluate the effects of last meal composition and timing on sleep quality and circadian gene expression among medical residents in Jordanian hospitals. Sleep disturbances are common in this population due to long working hours, high stress, and irregular eating schedules. Chrono-nutrition, the science of aligning food intake with circadian rhythms, may provide a practical approach to improving sleep and overall well-being.
Participants will be randomly assigned to one of three groups:
- High-carbohydrate last meal (≈80% of dinner calories from carbohydrates),
- High-protein last meal (≈40-50% of dinner calories from protein),
- Control group consuming a balanced standard meal. Each participant will consume the assigned meal 3-4 hours before bedtime for two weeks. Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI) and smartwatch-derived parameters, while salivary samples collected pre- and post-intervention will be analyzed for CLOCK and BMAL1 gene expression. The study will also include dietary, anthropometric, and physical activity assessments.
This study has been approved by the Institutional Review Board of the University of Jordan (IRB No. 491/2025). Recruitment has not yet started. Enrollment is expected to begin in December 2025, with primary data collection completed by June 2026 and final study completion by December 2026.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Currently enrolled and working in Jordanian hospitals.
- •Not currently following a specific diet or weight-loss program.
- •Willing to comply with study protocol and intervention meals for two weeks. Provide written informed consent before participation.
排除标准
- •Presence of any chronic medical condition (e.g., diabetes, thyroid disorders, gastrointestinal, cardiovascular, or respiratory diseases).
- •Diagnosed sleep disorders, such as insomnia, sleep apnea, or restless legs syndrome.
- •Mental health disorders (stress, anxiety, or depression diagnosed or medicated).
- •Pregnancy or lactation.
- •Use of medications or herbal supplements known to affect sleep (e.g., melatonin, chamomile, ashwagandha, lavender).
- •Caffeine dependence exceeding moderate levels ( >400 mg caffeine/day).
结局指标
主要结局
Change in Sleep Quality (PSQI Global Score)
时间窗: Baseline and 2 weeks post-intervention
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI) before and after the 2-week intervention. The PSQI total score (0-21) will quantify subjective sleep quality; higher scores indicate poorer sleep
次要结局
- Change in CLOCK Gene Expression(Baseline and 2 weeks post-intervention)
- Change in BMAL-1 Gene Expression(Baseline and 2 weeks post-intervention)
- Change in Total Sleep Duration(1 week baseline and 2 weeks during intervention)
- Change in Sleep Efficiency(1 week baseline and 2 weeks during intervention)
- Change in Sleep Stage Distribution(1 week baseline and 2 weeks during intervention)
- Change in Average Heart Rate During Sleep(1 week baseline and 2 weeks during intervention)
研究者
Hadeel Ali Ghazzawi
Prof.
University of Jordan