NCT07339592

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2025

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2025

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 14, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

1 month

First QC Date

December 16, 2025

Last Update Submit

January 4, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Sleep Quality (PSQI Global Score)

    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

    Baseline and 2 weeks post-intervention

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (3)

High-Carbohydrate Last Meal

EXPERIMENTAL

Dinner ≈30% of daily kcal; \~80% of dinner kcal from carbs; consumed 3-4 h before sleep for 2 weeks.

Dietary Supplement: High-Carbohydrate Last Meal

High-Protein Last Meal

EXPERIMENTAL

≈30% of daily kcal; \~38-54% of dinner kcal from protein; consumed 3-4 h before sleep for 2 weeks.

Dietary Supplement: High-Protein Last Meal

Balanced Standard last meal

ACTIVE COMPARATOR

Standard balanced dinner (per usual guidelines), same timing (3-4 h pre-sleep) and 2 weeks duration.

Dietary Supplement: Balanced Standard Dinner

Interventions

High-Carbohydrate Last MealDIETARY_SUPPLEMENT

Dinner ≈30% daily kcal; \~80% carb; taken 3-4 h before sleep for 2 weeks

High-Carbohydrate Last Meal
High-Protein Last MealDIETARY_SUPPLEMENT

Dinner ≈30% daily kcal; \~38-54% protein; 3-4 h before sleep for 2 weeks.

High-Protein Last Meal
Balanced Standard DinnerDIETARY_SUPPLEMENT

Standard macronutrient distribution; same timing (3-4h pre-sleep) and 2-week duration.

Balanced Standard last meal

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Jordan Hospital

Amman, Jordan

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Hadeel A Ghazzawi, professor

    The University of Jordan School of Agriculture

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

December 16, 2025

First Posted

January 14, 2026

Study Start

December 1, 2025

Primary Completion

January 1, 2026

Study Completion

May 1, 2026

Last Updated

January 14, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations