The Efficacy of Proper Breakfast Times on Cognitive Function

Not Applicable

Not yet recruiting

• Conditions: Nutrition, Healthy; Eating, Time Restricted; Cognitive Change; Blood Pressure
• Interventions: Other: breakfast 6.30 am; Other: breakfast 7.31 am

• Registration Number: NCT06541392
• Lead Sponsor: University of Muhammadiyah Aceh

Brief 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. 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 Timeline

• Study First Submitted: 2024-07-30
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-06
• Last Update Submitted: 2024-08-06
• Study First Posted: 2024-08-07
• Last Update Posted: 2024-08-07
• Study Start: 2024-08-15
• Primary Completion: 2024-12-30
• Study Completion: 2025-01-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Breakfast1	breakfast 6.30 am	This group will have breakfast time at 6.30 to 7.30 am
Breakfast2	breakfast 7.31 am	This group will have breakfast time from 7.31 am to 8.31 am

Primary Outcome Measures

Name	Time	Method
Focus	8 weeks	To determine the changes in focus between the groups using the Army alpha test
Mood	8 weeks	To determine the changes in mood between the groups using the profile of moods state (POMS) questionnaire

Secondary Outcome Measures

Name	Time	Method
Heart rate	8 weeks	To determine the changes in heart rate between the groups using the sphygmomanometer
Diastolic blood pressure	8 weeks	To determine the changes in diastolic blood pressure between the groups using the sphygmomanometer
macro nutrition intake	8 weeks	To determine the changes in macro nutrition intake between the groups using the 3-day food record
Systolic blood pressure	8 weeks	To determine the changes in systolic blood pressure between the groups using the sphygmomanometer
micro-nutrition	8 weeks	To determine the changes in micro-nutrition intake between the groups using the 3-day food record