Fasting StateOMADNCT07181057
Neurocognitive Effects of Meal Timing in a One-Meal-a-Day Regimen
A study testing one-meal-a-day (OMAD) in people with Fasting State and Cognitive Abilities, run by Erzurum Technical University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Fasting State, Cognitive Abilities
- What is being tested?
- one-meal-a-day (OMAD)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2025to 15 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erzurum Technical University Sport Sciences Faculty
Erzurum, Erzurum, 25240
About this study
Official title: Synergistic Effects of Green Tea Extract and Ginger Supplementation on Endurance Performance and Thermal Perception in Normal and Cold Environments: A Randomized, Double-Blind, Placebo-Controlled, Crossover Study
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.
- Conditions
- Fasting State, Cognitive Abilities
- Being tested
- one-meal-a-day (OMAD)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
one-meal-a-day (OMAD)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: one-meal-a-day (OMAD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Broadband spectral power (µV²) recorded at CP1, CP2, Pz, P3, O1, and O2 electrodes during standardized eyes-open and eyes-closed resting-state EEG.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start1 Mar 2025
- Primary completion1 May 2025
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fasting StateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erzurum Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Süleyman Ulupınar, Erzurum Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07181057
- Sponsor's protocol ID
- ETU-OMAD-2025-01
- Acronym
- OMAD
- Status last verified
- Aug 2025
- First submitted
- 25 Aug 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synergistic Effects of Green Tea Extract and Ginger Supplementation on Endurance Performance and Thermal Perception in Normal and Cold Environments: A Randomized, Double-Blind, Placebo-Controlled, Crossover Study
- ClinicalTrials.gov ID
- NCT07181057
- Acronym / sponsor ID
- OMAD / ETU-OMAD-2025-01
- Conditions
- Fasting State, Cognitive Abilities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Erzurum Technical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group (Crossover) | Experimental | Other: one-meal-a-day (OMAD)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 |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| one-meal-a-day (OMAD)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. | Other | Single Group (Crossover) |
Primary outcome
Positive Peak Amplitude of Event-Related Potentials During Stroop - Congruent Trials
Time frame: 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.
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.
Latency of Positive Peak of Event-Related Potentials During Stroop - Congruent Trials
Time frame: 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.
Time point (ms) of maximum positive deflection within 250-450 ms after stimulus onset at CP1, CP2, Pz, P3, O1, and O2 electrodes.
1 secondary outcome
Resting-State EEG Absolute Power (Eyes-Open and Eyes-Closed)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing one-meal-a-day (OMAD) in people with Fasting State and Cognitive Abilities, run by Erzurum Technical University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Peak Amplitude of Event-Related Potentials During Stroop - Congruent Trials (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.