NCT06541392

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 7, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

August 15, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2025

Completed
Last Updated

August 7, 2024

Status Verified

August 1, 2024

Enrollment Period

5 months

First QC Date

July 30, 2024

Last Update Submit

August 6, 2024

Conditions

Eating, Time RestrictedCognitive ChangeBlood PressureNutrition, Healthy

Outcome Measures

Primary Outcomes (2)

  • Focus

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

    8 weeks

  • Mood

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

    8 weeks

Secondary Outcomes (5)

  • Systolic blood pressure

    8 weeks

  • Diastolic blood pressure

    8 weeks

  • Heart rate

    8 weeks

  • macro nutrition intake

    8 weeks

  • micro-nutrition

    8 weeks

Study Arms (3)

Breakfast1

EXPERIMENTAL

This group will have breakfast time at 6.30 to 7.30 am

Other: breakfast 6.30 am

Breakfast2

EXPERIMENTAL

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

Other: breakfast 7.31 am

Control

NO INTERVENTION

This group will have breakfast time according to their wishes.

Interventions

breakfast 6.30 amOTHER

This group will have breakfast time from 6.30 to 7.30 am

Breakfast1
breakfast 7.31 amOTHER

This group will have breakfast time from 7.31 to 8.31 am

Breakfast2

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 33724048BACKGROUND

  • 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.

    PMID: 38013523BACKGROUND

  • 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.

    PMID: 35200521RESULT

  • 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.

    PMID: 38135050RESULT

  • 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.

    PMID: 37375582RESULT

MeSH Terms

Conditions

Intermittent Fasting

Condition Hierarchy (Ancestors)

FastingFeeding BehaviorBehavior

Study Officials

  • Riza Septiani, Ph.D

    University of Muhammadiyah Aceh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dharina Baharuddin, MPH

CONTACT

+6285260963094dharinabaharuddin@gmail.com

Maidar Abdul Manan, Ph.D

CONTACT

+628126439913maidar7117@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

July 30, 2024

First Posted

August 7, 2024

Study Start

August 15, 2024

Primary Completion

December 30, 2024

Study Completion

January 30, 2025

Last Updated

August 7, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share