The Efficacy of Proper Breakfast Times on Cognitive Function

NCT ID: NCT06541392

Last Updated: 2024-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-15

Study Completion Date

2025-01-30

Brief Summary

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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

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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.

Conditions

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Eating, Time Restricted Cognitive Change Blood Pressure Nutrition, Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Breakfast1

This group will have breakfast time at 6.30 to 7.30 am

Group Type EXPERIMENTAL

breakfast 6.30 am

Intervention Type OTHER

This group will have breakfast time from 6.30 to 7.30 am

Breakfast2

This group will have breakfast time from 7.31 am to 8.31 am

Group Type EXPERIMENTAL

breakfast 7.31 am

Intervention Type OTHER

This group will have breakfast time from 7.31 to 8.31 am

Control

This group will have breakfast time according to their wishes.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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breakfast 6.30 am

This group will have breakfast time from 6.30 to 7.30 am

Intervention Type OTHER

breakfast 7.31 am

This group will have breakfast time from 7.31 to 8.31 am

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Muhammadiyah Aceh

OTHER

Sponsor Role lead

Responsible Party

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Riza Septiani

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Riza Septiani, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of Muhammadiyah Aceh

Central Contacts

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Dharina Baharuddin, MPH

Role: CONTACT

+6285260963094

Maidar Abdul Manan, Ph.D

Role: CONTACT

+628126439913

References

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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.

Reference Type BACKGROUND
PMID: 33724048 (View on PubMed)

Baharuddin 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.

Reference Type BACKGROUND
PMID: 38013523 (View on PubMed)

Crabtree 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.

Reference Type RESULT
PMID: 35200521 (View on PubMed)

Dalgaard 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.

Reference Type RESULT
PMID: 38135050 (View on PubMed)

Xian 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.

Reference Type RESULT
PMID: 37375582 (View on PubMed)

Other Identifiers

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LP4MRiset

Identifier Type: -

Identifier Source: org_study_id

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