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Not yet recruiting NCT06541392

The Efficacy of Proper Breakfast Times on Cognitive Function

No phase Interventional Eating, Time Restricted Cognitive Change Blood Pressure Nutrition, Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: breakfast 6.30 am, breakfast 7.31 am.
Who it may be relevant to
Registry conditions: Eating, Time Restricted, Cognitive Change, Blood Pressure, Nutrition, Healthy. Basic parameters: 18 years — 24 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Other breakfast 6.30 am
    This group will have breakfast time from 6.30 to 7.30 am
  • Other breakfast 7.31 am
    This group will have breakfast time from 7.31 to 8.31 am

Primary outcome measures

  • Focus [Time frame: 8 weeks]
  • Mood [Time frame: 8 weeks]
Secondary outcome measures (5)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 33724048
  • 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 38013523
  • 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 35200521
  • 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 38135050
  • 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 37375582

Identifiers

NCT: NCT06541392 · LP4MRiset

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗