NCT07181057

Brief Summary

Objectives: The purpose of this study is to examine how meal timing in a one-meal-a-day (OMAD) regimen influences neurocognitive outcomes. Methods: Twelve cognitively active participants (academics, students, software engineers) will complete three randomized OMAD conditions, consuming a standardized isocaloric meal at 08:00, 12:30, or 18:00. ERPs will be recorded during a computerized Stroop task to evaluate peak amplitudes and latencies under congruent and incongruent conditions. Resting-state EEG will be measured under eyes-open and eyes-closed conditions. Behavioral performance on the Stroop task, including reaction time and accuracy, will also be assessed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

September 18, 2025

Completed
Last Updated

September 18, 2025

Status Verified

August 1, 2025

Enrollment Period

2 months

First QC Date

August 25, 2025

Last Update Submit

September 11, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Positive Peak Amplitude of Event-Related Potentials During Stroop - Congruent Trials

    Maximum voltage deflection (µV) within 250-450 ms after stimulus onset at CP1, CP2, Pz, P3, O1, and O2 electrodes, recorded during congruent Stroop trials using a 32-channel EEG system.

    Day 1 Morning session (09:30-11:00, pre-meal) and Day 1 Afternoon session (14:30-16:00, ~6 hours post-meal). Each participant completes three separate test days (morning, midday, evening feeding), ≥48 hours apart.

  • Latency of Positive Peak of Event-Related Potentials During Stroop - Congruent Trials

    Time point (ms) of maximum positive deflection within 250-450 ms after stimulus onset at CP1, CP2, Pz, P3, O1, and O2 electrodes.

    Day 1 Morning session (09:30-11:00, pre-meal) and Day 1 Afternoon session (14:30-16:00, ~6 hours post-meal). Each participant completes three separate test days (morning, midday, evening feeding), ≥48 hours apart.

Secondary Outcomes (1)

  • Resting-State EEG Absolute Power (Eyes-Open and Eyes-Closed)

    Day 1 Morning session (09:30-11:00, pre-meal) and Day 1 Afternoon session (14:30-16:00, ~6 hours post-meal). Each participant completes three separate test days (morning, midday, evening feeding), ≥48 hours apart.

Study Arms (1)

Single Group (Crossover)

EXPERIMENTAL

Arm Title: Morning Meal (08:00) Arm Type: Experimental Intervention: Other: One-meal-a-day (OMAD) Arm Description: Participants consume a single standardized isocaloric meal at 08:00. Neurocognitive outcomes (ERP, resting-state EEG, Stroop performance) are assessed during morning (before meal) and afternoon (approximately 6 hours post-meal) sessions. Arm Title: Midday Meal (12:30) Arm Type: Experimental Intervention: Other: One-meal-a-day (OMAD) Arm Description: Participants consume a single standardized isocaloric meal at 12:30. Neurocognitive outcomes (ERP, resting-state EEG, Stroop performance) are assessed during morning (before meal) and afternoon (approximately 6 hours post-meal) sessions. Arm Title: Evening Meal (18:00) Arm Type: Experimental Intervention: Other: One-meal-a-day (OMAD) Arm Description: Participants consume a single standardized isocaloric meal at 18:00. Neurocognitive outcomes (ERP, resting-state EEG, Stroop performance) are assessed during morning (before mea

Other: one-meal-a-day (OMAD)

Interventions

Arm Title: Morning Meal (08:00) Intervention: Other: One-meal-a-day (OMAD) Description: Participants consume a single isocaloric meal at 08:00. Arm Title: Midday Meal (12:30) Intervention: Other: One-meal-a-day (OMAD) Description: Participants consume a single isocaloric meal at 12:30. Arm Title: Evening Meal (18:00) Intervention: Other: One-meal-a-day (OMAD) Description: Participants consume a single isocaloric meal at 18:00.

Single Group (Crossover)

Eligibility Criteria

Age20 Years - 40 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsTo minimize hormone-related variability in electroencephalography and event-related potential measures in this pilot crossover study, enrollment is limited to males.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male, 20 to 45 years of age
  • Right-handed
  • Normal or corrected-to-normal vision
  • Cognitively active individuals (academic staff, graduate students, or software/algorithm engineers)
  • Regular sleep-wake schedule during the week preceding the experiment
  • Ability to abstain from caffeine, alcohol, or psychoactive substances for at least 24 hours prior to each test session
  • Body mass index between 18.5 and 30 kg/m²

You may not qualify if:

  • History of neurological, psychiatric, metabolic, or sleep disorders
  • Current use of medications that affect the central nervous system
  • Shift work or irregular sleep patterns (verified by sleep diary)
  • Prior experience with one-meal-a-day dietary routines
  • Body mass index below 18.5 or above 30 kg/m²

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erzurum Technical University Sport Sciences Faculty

Erzurum, Erzurum, 25240, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Exercise Physiology

Study Record Dates

First Submitted

August 25, 2025

First Posted

September 18, 2025

Study Start

March 1, 2025

Primary Completion

May 1, 2025

Study Completion

May 15, 2025

Last Updated

September 18, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations