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NCT Number: NCT06541392

The Efficacy of Proper Breakfast Times on Cognitive Function

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.

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Key information

Conditions

Eating, Time Restricted Behavior Blood Pressure Cognitive Change Fasting Feeding Behavior Intermittent Fasting Nutrition, Healthy

Age range

18 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Abstain in the education session
  • Having emotional and mental health problems
  • Students in the final class who are undergoing the thesis writing

Treatment and study plan

breakfast 6.30 am

Other

This group will have breakfast time from 6.30 to 7.30 am

breakfast 7.31 am

Other

This group will have breakfast time from 7.31 to 8.31 am

Primary outcomes

  1. Focus

    Time frame: 8 weeks

    To determine the changes in focus between the groups using the Army alpha test

  2. Mood

    Time frame: 8 weeks

    To determine the changes in mood between the groups using the profile of moods state (POMS) questionnaire

Secondary outcomes

  1. Systolic blood pressure

    Time frame: 8 weeks

    To determine the changes in systolic blood pressure between the groups using the sphygmomanometer

  2. Diastolic blood pressure

    Time frame: 8 weeks

    To determine the changes in diastolic blood pressure between the groups using the sphygmomanometer

  3. Heart rate

    Time frame: 8 weeks

    To determine the changes in heart rate between the groups using the sphygmomanometer

  4. macro nutrition intake

    Time frame: 8 weeks

    To determine the changes in macro nutrition intake between the groups using the 3-day food record

  5. micro-nutrition

    Time frame: 8 weeks

    To determine the changes in micro-nutrition intake between the groups using the 3-day food record

Study contacts

Contact information is provided by the study sponsor or research team.

Dharina Baharuddin, MPH

CONTACT

[email protected]

+6285260963094

Maidar Abdul Manan, Ph.D

CONTACT

[email protected]

+628126439913

Sponsors and collaborators

Lead sponsor

University of Muhammadiyah Aceh

Other

Registry information

Official study title

The Effectiveness of Proper Breakfast Times on Cognitive Function and Health Outcomes Among College Students

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Aug 7, 2024
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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