NCT06679088

Brief Summary

Breakfasts with a high glycaemic index (GI) resulting in sharp rises in blood glucose may adversely affect memory and attention, particularly in the late postprandial phase (i.e., 120-180 minutes after breakfast). Young adults may be particularly responsive to these adverse effects on cognition since they are prone to experience circadian misalignment because their midpoint of sleep (i.e., chronotype) is biologically most delayed in young adulthood. Our recent research suggests that persons with a later chronotype exhibit no diurnal difference in response to a high GI meal consumed in the morning and evening, suggesting that consumption of an early breakfast "against the inner clock" may be adverse for their glycaemic response and that consumption of an early breakfast may present a burden for those with a later chronotype. Indeed, persons with later chronotypes commonly tend to exhibit less favourable eating pattern. Hence, consuming an early breakfast, e.g. in preparation for an exam, may be more problematic for persons with later chronotypes and it may be more likely that these persons choose less favorable foods for breakfast. Thus, it remains to be clarified whether persons with a later chronotype:

  1. 1.usually consume breakfasts with a higher dietary GI than those with an earlier chronotype. Addressing this hypothesis needs to consider both the first and second breakfast (i.e., all meals until noon), since breakfast skipping may be common particularly among persons with a later chronotype
  2. 2.are more prone to consume foods from higher GI sources in preparation for an exam in the morning than those with an earlier chronotype.
  3. 3.consume breakfasts of a higher energy density and a lower micronutrient adequacy than persons with an earlier chronotype.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
9mo left

Started Oct 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Study Progress67%
Oct 2024Feb 2027

Study Start

First participant enrolled

October 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 5, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Expected
Last Updated

April 3, 2025

Status Verified

November 1, 2024

Enrollment Period

5 months

First QC Date

November 5, 2024

Last Update Submit

March 31, 2025

Conditions

Keywords

ChronotypeBreakfastGlyceamic IndexMCTQAcademic performanceDietary patternsStudent nutritionNutrient composition

Outcome Measures

Primary Outcomes (2)

  • Breakfast quality, dietary GI and nutrient composition

    2 times Computer-assisted 24-hour recall of consumed foods and beverages in the past 24 h

    At inclusion into the study and after 6 days

  • Breakfast food choice in preparation of an exam

    Questionnaire inquiring selected food items, beverages and meal replacements

    Assessed once at the beginning of the study

Study Arms (1)

students of Paderborn University

18 years to 25 years (adult)

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Students at Paderborn University (see inclusion criteria)

You may qualify if:

  • Students at Paderborn University aged between 18 and 25 years
  • Proficient in the German language because all questionnaires are in German.

You may not qualify if:

  • Students studying nutritional science and home economics
  • acute or permanent use of sleep-promoting medications (including herbal preparation):
  • chemical medications: melatonin, diphenhydramine, doxylamine
  • herbal preparations: hops, St. John's wort, lemon balm, lavender, passionflower, Baldurat, Neurexan, cannabinoids
  • Use of psychotropic medications (antidepressants, tranquilizer, antipsychotics)
  • Use of methylphenidate (e.g. Ritalin, Medikinet, Concerta)
  • Use of cannabinoids by prescription
  • Continuous administration of antihistamines when discontinuation is not feasible during the intervention
  • Use of herbal preparations affecting memory and concentration (e.g. gingko, ginseng, ashwagandha)
  • Use of other medications (e.g. insulin, metformin, SGLT2 inhibitors, steroids, ACE inhibitors)
  • Selected chronic diseases (depression and other mental disorders such as anxiety disorder, ADHD, diabetes mellitus (all types), prediabetes, blood clotting disorders (e.g., thrombocytopenia, hemophilia), eating disorders (e.g., anorexia, binge eating, bulimia)
  • Addiction disorders (e.g., alcohol, drug, or medication dependency)
  • Chronic inflammatory bowel diseases
  • infectious diseases (HIV, hepatitis)
  • Pregnant and breastfeeding individuals
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Paderborn University

Paderborn, North-Rhine-Westfalia, 33098, Germany

Location

Related Publications (11)

  • Koch SAJ, Conrad J, Cade JE, Weinhold L, Alexy U, Nothlings U. Validation of the web-based self-administered 24-h dietary recall myfood24-Germany: comparison with a weighed dietary record and biomarkers. Eur J Nutr. 2021 Oct;60(7):4069-4082. doi: 10.1007/s00394-021-02547-7. Epub 2021 May 11.

    PMID: 33974128BACKGROUND
  • Koch SAJ, Conrad J, Hierath L, Hancock N, Beer S, Cade JE, Nothlings U. Adaptation and Evaluation of Myfood24-Germany: A Web-Based Self-Administered 24-h Dietary Recall for the German Adult Population. Nutrients. 2020 Jan 6;12(1):160. doi: 10.3390/nu12010160.

    PMID: 31935885BACKGROUND
  • Nowack K, Van Der Meer E. The synchrony effect revisited: chronotype, time of day and cognitive performance in a semantic analogy task. Chronobiol Int. 2018 Nov;35(12):1647-1662. doi: 10.1080/07420528.2018.1500477. Epub 2018 Aug 7.

    PMID: 30085831BACKGROUND
  • Xiao Q, Garaulet M, Scheer FAJL. Meal timing and obesity: interactions with macronutrient intake and chronotype. Int J Obes (Lond). 2019 Sep;43(9):1701-1711. doi: 10.1038/s41366-018-0284-x. Epub 2019 Jan 31.

    PMID: 30705391BACKGROUND
  • Pengpid S, Peltzer K. Skipping Breakfast and Its Association with Health Risk Behaviour and Mental Health Among University Students in 28 Countries. Diabetes Metab Syndr Obes. 2020 Aug 18;13:2889-2897. doi: 10.2147/DMSO.S241670. eCollection 2020.

    PMID: 32884315BACKGROUND
  • Ballon A, Neuenschwander M, Schlesinger S. Breakfast Skipping Is Associated with Increased Risk of Type 2 Diabetes among Adults: A Systematic Review and Meta-Analysis of Prospective Cohort Studies. J Nutr. 2019 Jan 1;149(1):106-113. doi: 10.1093/jn/nxy194.

    PMID: 30418612BACKGROUND
  • Ma X, Chen Q, Pu Y, Guo M, Jiang Z, Huang W, Long Y, Xu Y. Skipping breakfast is associated with overweight and obesity: A systematic review and meta-analysis. Obes Res Clin Pract. 2020 Jan-Feb;14(1):1-8. doi: 10.1016/j.orcp.2019.12.002. Epub 2020 Jan 7.

    PMID: 31918985BACKGROUND
  • Gibney MJ, Barr SI, Bellisle F, Drewnowski A, Fagt S, Livingstone B, Masset G, Varela Moreiras G, Moreno LA, Smith J, Vieux F, Thielecke F, Hopkins S. Breakfast in Human Nutrition: The International Breakfast Research Initiative. Nutrients. 2018 May 1;10(5):559. doi: 10.3390/nu10050559.

    PMID: 29723985BACKGROUND
  • Kanerva N, Kronholm E, Partonen T, Ovaskainen ML, Kaartinen NE, Konttinen H, Broms U, Mannisto S. Tendency toward eveningness is associated with unhealthy dietary habits. Chronobiol Int. 2012 Aug;29(7):920-7. doi: 10.3109/07420528.2012.699128.

    PMID: 22823875BACKGROUND
  • Mazri FH, Manaf ZA, Shahar S, Mat Ludin AF. The Association between Chronotype and Dietary Pattern among Adults: A Scoping Review. Int J Environ Res Public Health. 2019 Dec 20;17(1):68. doi: 10.3390/ijerph17010068.

    PMID: 31861810BACKGROUND
  • Stutz B, Krueger B, Goletzke J, Jankovic N, Alexy U, Herder C, Dierkes J, Berg-Beckhoff G, Jakobsmeyer R, Reinsberger C, Buyken AE. Glycemic response to meals with a high glycemic index differs between morning and evening: a randomized cross-over controlled trial among students with early or late chronotype. Eur J Nutr. 2024 Aug;63(5):1593-1604. doi: 10.1007/s00394-024-03372-4. Epub 2024 Apr 12.

    PMID: 38605233BACKGROUND

Related Links

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Anette Buyken, Head of the research group "Public Health Nutrition"

Study Record Dates

First Submitted

November 5, 2024

First Posted

November 7, 2024

Study Start

October 1, 2024

Primary Completion

February 28, 2025

Study Completion (Estimated)

February 28, 2027

Last Updated

April 3, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations