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Набор по приглашению NCT07339592

This Trial Examines How Last Meal Composition and Timing Affect Sleep Quality and Circadian Gene Expression Among Medical Residents. Recruitment Not Yet Started; Study Begins Dec 2025 and Ends Dec 2026.

Без фазы С лечением Sleep Quality Meal Timing Circadian Rhythm Medical Residents

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: High-Carbohydrate Last Meal, High-Protein Last Meal, Balanced Standard Dinner.
Кому может быть актуально
Состояния в реестре: Sleep Quality, Meal Timing, Circadian Rhythm, Medical Residents. Базовые параметры: от 25 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Иордания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

CHRONO-NUTRITION INTERVENTIONS FOR IMPROVING SLEEP QUALITY: The Impact of Last Meal Composition and Timing on Sleep Quality Among Medical Residents at Hospitals

Обзор

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: 1. High-carbohydrate last meal (≈80% of dinner calories from carbohydrates), 2. High-protein last meal (≈40-50% of dinner calories from protein), 3. 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.

Вмешательства

  • Пищевая добавка High-Carbohydrate Last Meal
    Dinner ≈30% daily kcal; \~80% carb; taken 3-4 h before sleep for 2 weeks
  • Пищевая добавка High-Protein Last Meal
    Dinner ≈30% daily kcal; \~38-54% protein; 3-4 h before sleep for 2 weeks.
  • Пищевая добавка Balanced Standard Dinner
    Standard macronutrient distribution; same timing (3-4h pre-sleep) and 2-week duration.

Первичные конечные точки

  • Change in Sleep Quality (PSQI Global Score) [Срок оценки: Baseline and 2 weeks post-intervention]
Вторичные конечные точки (6)
  • Change in CLOCK Gene Expression [Срок оценки: Baseline and 2 weeks post-intervention]
  • Change in BMAL-1 Gene Expression [Срок оценки: Baseline and 2 weeks post-intervention]
  • Change in Total Sleep Duration [Срок оценки: 1 week baseline and 2 weeks during intervention]
  • Change in Sleep Efficiency [Срок оценки: 1 week baseline and 2 weeks during intervention]
  • Change in Sleep Stage Distribution [Срок оценки: 1 week baseline and 2 weeks during intervention]
  • Change in Average Heart Rate During Sleep [Срок оценки: 1 week baseline and 2 weeks during intervention]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Профилактика

Центры проведения

Иордания · 1 центр
  • University of Jordan Hospital — Amman

Идентификаторы

NCT: NCT07339592 · University of Jordan 491/2025

Первоисточники (государственные реестры)

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