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.
NCT ID: NCT07339592
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
90 participants
INTERVENTIONAL
2025-12-01
2026-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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High-Carbohydrate Last Meal
Dinner ≈30% of daily kcal; \~80% of dinner kcal from carbs; consumed 3-4 h before sleep for 2 weeks.
High-Carbohydrate Last Meal
Dinner ≈30% daily kcal; \~80% carb; taken 3-4 h before sleep for 2 weeks
High-Protein Last Meal
≈30% of daily kcal; \~38-54% of dinner kcal from protein; consumed 3-4 h before sleep for 2 weeks.
High-Protein Last Meal
Dinner ≈30% daily kcal; \~38-54% protein; 3-4 h before sleep for 2 weeks.
Balanced Standard last meal
Standard balanced dinner (per usual guidelines), same timing (3-4 h pre-sleep) and 2 weeks duration.
Balanced Standard Dinner
Standard macronutrient distribution; same timing (3-4h pre-sleep) and 2-week duration.
Interventions
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High-Carbohydrate Last Meal
Dinner ≈30% daily kcal; \~80% carb; taken 3-4 h before sleep for 2 weeks
High-Protein Last Meal
Dinner ≈30% daily kcal; \~38-54% protein; 3-4 h before sleep for 2 weeks.
Balanced Standard Dinner
Standard macronutrient distribution; same timing (3-4h pre-sleep) and 2-week duration.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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).
25 Years
ALL
Yes
Sponsors
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University of Jordan
OTHER
Responsible Party
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Hadeel Ali Ghazzawi
Prof.
Principal Investigators
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Hadeel A Ghazzawi, professor
Role: PRINCIPAL_INVESTIGATOR
The University of Jordan School of Agriculture
Locations
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University of Jordan Hospital
Amman, , Jordan
Countries
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Other Identifiers
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University of Jordan 491/2025
Identifier Type: -
Identifier Source: org_study_id
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