Eating, Time RestrictedNCT06541392
The Efficacy of Proper Breakfast Times on Cognitive Function
A study testing breakfast 6.30 am and breakfast 7.31 am in people with Eating, Time Restricted and Cognitive Change, run by University of Muhammadiyah Aceh.
Trial summary
The goal of this cluster randomized controlled trial is to learn if a proper breakfast time may increase cognitive function. It will also learn about the effectiveness of proper breakfast time on health outcomes. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Eating, Time Restricted, Cognitive Change, Blood Pressure
- What is being tested?
- breakfast 6.30 am and breakfast 7.31 am
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2024to 30 Jan 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 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Active student in the year 2024
- Not in medication
- Do not have gastritis or any diseases that require to have breakfast earlier in the morning
- Willing to sign an informed consent
- Have health insurance
Who cannot join
- Abstain in the education session
- Having emotional and mental health problems
- Students in the final class who are undergoing the thesis writing
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effectiveness of Proper Breakfast Times on Cognitive Function and Health Outcomes Among College Students
The goal of this cluster randomized controlled trial is to learn if a proper breakfast time may increase cognitive function. It will also learn about the effectiveness of proper breakfast time on health outcomes. The main questions it aims to answer are:
Does a proper breakfast time increase cognitive function and health outcomes?
Participants will:
- wake up in the morning at 6 o'clock
- Having breakfast at 6.30 - 7.30 am or 7.31-8.31 am, or having breakfast time according to their wishes.
- Having lunch started at 12.00 pm.
Read the detailed description
This experimental study uses a Cluster Randomized Controlled Trial non-blinding parallel method design. The objective of this study is to assess the effectiveness of proper breakfast time on cognitive function including the focus on learning and mood among university students. Additionally, the study determines health outcomes such as heart rate, systolic blood pressure, diastolic blood pressure, and macro and micronutrient intake. There are a total of 60 participants from three different faculties. All faculties will be randomly selected and assigned to intervention group 1, intervention group 2, and the control group. Each group consists of 20 participants from each faculty in the university. Intervention Group 1 will have breakfast from 6:30 to 7:30 am, and Intervention Group 2 from 7:31 to 8:31 am. Meanwhile, the control group will continue their preferred breakfast routine. The intervention groups are required to wake up at 6:00 am and have lunch at 12:00 pm.
- Being tested
- breakfast 6.30 am, breakfast 7.31 am
- Medical subject headings
- Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breakfast 6.30 amOther
This group will have breakfast time from 6.30 to 7.30 am
breakfast 7.31 amOther
This group will have breakfast time from 7.31 to 8.31 am
| Study group | Role | What they receive |
|---|---|---|
| Breakfast1 | Experimental | This group will have breakfast time at 6.30 to 7.30 am Receives: Other: breakfast 6.30 am |
| Breakfast2 | Experimental | This group will have breakfast time from 7.31 am to 8.31 am Receives: Other: breakfast 7.31 am |
| Control | No intervention | This group will have breakfast time according to their wishes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Focus
To determine the changes in focus between the groups using the Army alpha test
Measured: 8 weeks
Mood
To determine the changes in mood between the groups using the profile of moods state (POMS) questionnaire
Measured: 8 weeks
Secondary outcomes (5)
Systolic blood pressure
To determine the changes in systolic blood pressure between the groups using the sphygmomanometer
Measured: 8 weeks
Diastolic blood pressure
To determine the changes in diastolic blood pressure between the groups using the sphygmomanometer
Measured: 8 weeks
Heart rate
To determine the changes in heart rate between the groups using the sphygmomanometer
Measured: 8 weeks
macro nutrition intake
To determine the changes in macro nutrition intake between the groups using the 3-day food record
Measured: 8 weeks
micro-nutrition
To determine the changes in micro-nutrition intake between the groups using the 3-day food record
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start15 Aug 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Eating, Time RestrictedStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Muhammadiyah Aceh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riza Septiani, University of Muhammadiyah Aceh
- Investigators
- Riza Septiani, Ph.D, Principal investigator, University of Muhammadiyah Aceh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06541392
- Sponsor's protocol ID
- LP4MRiset
- Status last verified
- Aug 2024
- First submitted
- 30 Jul 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moreno-Aznar LA, Vidal Carou MDC, Lopez Sobaler AM, Varela-Moreiras G, Moreno Villares JM. [Role of breakfast and its quality in the health of children and adolescents in Spain]. Nutr Hosp. 2021 Apr 19;38(2):396-409. doi: 10.20960/nh.03398. Spanish.
PubMed 33724048Baharuddin D, Said MA, Majid HA. Protocol For Intervention Study In Reducing Elevated Blood Pressure Through Intermittent Fasting. J Pak Med Assoc. 2023 Nov;73(11):2171-2176. doi: 10.47391/JPMA.7748.
PubMed 38013523Crabtree DR, Holliday A, Buosi W, Fyfe CL, Horgan GW, Johnstone AM, On Behalf Of The Full Health-Study Group. The Acute Effects of Breakfast Drinks with Varying Protein and Energy Contents on Appetite and Free-Living Energy Intake in UK Older Adults. Geriatrics (Basel). 2022 Jan 30;7(1):16. doi: 10.3390/geriatrics7010016.
PubMed 35200521Dalgaard LB, Kruse DZ, Norup K, Andersen BV, Hansen M. A dairy-based, protein-rich breakfast enhances satiety and cognitive concentration before lunch in overweight to obese young females: A randomized controlled crossover study. J Dairy Sci. 2024 May;107(5):2653-2667. doi: 10.3168/jds.2023-24152. Epub 2023 Dec 21.
PubMed 38135050Xian X, Wang C, Yu R, Ye M. Breakfast Frequency and Sleep Quality in College Students: The Multiple Mediating Effects of Sleep Chronotypes and Depressive Symptoms. Nutrients. 2023 Jun 8;15(12):2678. doi: 10.3390/nu15122678.
PubMed 37375582
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Proper Breakfast Times on Cognitive Function and Health Outcomes Among College Students
- ClinicalTrials.gov ID
- NCT06541392
- Acronym / sponsor ID
- LP4MRiset
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Muhammadiyah AcehUniversity, hospital or other
- Study start
- 15 Aug 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 7 Aug 2024 (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.
The goal of this cluster randomized controlled trial is to learn if a proper breakfast time may increase cognitive function. It will also learn about the effectiveness of proper breakfast time on health outcomes. The main questions it aims to answer are:
Does a proper breakfast time increase cognitive function and health outcomes?
Participants will:
- wake up in the morning at 6 o'clock
- Having breakfast at 6.30 - 7.30 am or 7.31-8.31 am, or having breakfast time according to their wishes.
- Having lunch started at 12.00 pm.
Detailed description
This experimental study uses a Cluster Randomized Controlled Trial non-blinding parallel method design. The objective of this study is to assess the effectiveness of proper breakfast time on cognitive function including the focus on learning and mood among university students. Additionally, the study determines health outcomes such as heart rate, systolic blood pressure, diastolic blood pressure, and macro and micronutrient intake. There are a total of 60 participants from three different faculties. All faculties will be randomly selected and assigned to intervention group 1, intervention group 2, and the control group. Each group consists of 20 participants from each faculty in the university. Intervention Group 1 will have breakfast from 6:30 to 7:30 am, and Intervention Group 2 from 7:31 to 8:31 am. Meanwhile, the control group will continue their preferred breakfast routine. The intervention groups are required to wake up at 6:00 am and have lunch at 12:00 pm.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Breakfast1 | Experimental | Other: breakfast 6.30 amThis group will have breakfast time at 6.30 to 7.30 am |
| Breakfast2 | Experimental | Other: breakfast 7.31 amThis group will have breakfast time from 7.31 am to 8.31 am |
| Control | No intervention | –This group will have breakfast time according to their wishes. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Active student in the year 2024
- Not in medication
- Do not have gastritis or any diseases that require to have breakfast earlier in the morning
- Willing to sign an informed consent
- Have health insurance
Key exclusion criteria (3 listed)
- Abstain in the education session
- Having emotional and mental health problems
- Students in the final class who are undergoing the thesis writing
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 |
|---|---|---|
| breakfast 6.30 amThis group will have breakfast time from 6.30 to 7.30 am | Other | Breakfast1 |
| breakfast 7.31 amThis group will have breakfast time from 7.31 to 8.31 am | Other | Breakfast2 |
Primary outcome
Focus
Time frame: 8 weeks
To determine the changes in focus between the groups using the Army alpha test
Mood
Time frame: 8 weeks
To determine the changes in mood between the groups using the profile of moods state (POMS) questionnaire
5 secondary outcomes
Systolic blood pressure
Time frame: 8 weeks
Diastolic blood pressure
Time frame: 8 weeks
Heart rate
Time frame: 8 weeks
macro nutrition intake
Time frame: 8 weeks
micro-nutrition
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Background: PubMed 33724048Moreno-Aznar LA, Vidal Carou MDC, Lopez Sobaler AM, Varela-Moreiras G, Moreno Villares JM. [Role of breakfast and its quality in the health of children and adolescents in Spain]. Nutr Hosp. 2021 Apr 19;38(2):396-409. doi: 10.20960/nh.03398. Spanish.
- Background: PubMed 38013523Baharuddin D, Said MA, Majid HA. Protocol For Intervention Study In Reducing Elevated Blood Pressure Through Intermittent Fasting. J Pak Med Assoc. 2023 Nov;73(11):2171-2176. doi: 10.47391/JPMA.7748.
- Results publication: PubMed 35200521Crabtree DR, Holliday A, Buosi W, Fyfe CL, Horgan GW, Johnstone AM, On Behalf Of The Full Health-Study Group. The Acute Effects of Breakfast Drinks with Varying Protein and Energy Contents on Appetite and Free-Living Energy Intake in UK Older Adults. Geriatrics (Basel). 2022 Jan 30;7(1):16. doi: 10.3390/geriatrics7010016.
- Results publication: PubMed 38135050Dalgaard LB, Kruse DZ, Norup K, Andersen BV, Hansen M. A dairy-based, protein-rich breakfast enhances satiety and cognitive concentration before lunch in overweight to obese young females: A randomized controlled crossover study. J Dairy Sci. 2024 May;107(5):2653-2667. doi: 10.3168/jds.2023-24152. Epub 2023 Dec 21.
- Results publication: PubMed 37375582Xian X, Wang C, Yu R, Ye M. Breakfast Frequency and Sleep Quality in College Students: The Multiple Mediating Effects of Sleep Chronotypes and Depressive Symptoms. Nutrients. 2023 Jun 8;15(12):2678. doi: 10.3390/nu15122678.
- 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.
Riza Septiani, Ph.D principal investigator
University of Muhammadiyah Aceh
Questions about this trial
What is this clinical trial studying?
A study testing breakfast 6.30 am and breakfast 7.31 am in people with Eating, Time Restricted and Cognitive Change, run by University of Muhammadiyah Aceh.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dharina Baharuddin, MPH (+6285260963094, dharinabaharuddin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Focus (time frame: 8 weeks). 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?
On the ClinicalTrials.gov record for NCT06541392, which also lists 5 linked publications.
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 7 Aug 2024.