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HealthyGlyCoBrainObNCT06679088

GlyCoBrain Observational Study

An observational study of Healthy and Adult, run by Paderborn University at 1 site in Germany.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 25 yearsHealthy volunteers can take part
Conditions the study is for
Healthy, Adult
How many people
350 participants
Where
1 siteGermany
Study dates
1 Oct 2024to 28 Feb 2027
How long will I take part?
1 Day
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 25 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: Students at Paderborn University (see inclusion criteria)

Who may be able to join

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

Who cannot join

  • 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)
Show all 17Show fewer
  • 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
  • Shift work or travel in the past 3 months across more than 2 time zones
  • students with a pacemaker/defibrillator

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Germany1 site
  • Paderborn University

    Paderborn, North-Rhine-Westfalia, 33098

Other trials in Germany

About this study

Official title: GlyCoBrain Observation - Breakfast Habits Among Students With Early and Late Chronotype

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:

Read more
  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. 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. consume breakfasts of a higher energy density and a lower micronutrient adequacy than persons with an earlier chronotype.

In this study (GlyCoBrain (Glycaemic index Cognition Brain) observational study), 350 students from the University of Paderborn, aged between 18 and 25, will be recruited until the end of February 2025. A questionnaire-based screening will assess breakfast habits and chronotype using the Munich ChronoType Questionnaire (MCTQ). In addition, students will be asked to fill in two 24-h recalls (myFood24) to provide information on their habitual diet (including breakfast). The screening will be followed by two controlled intervention studies examining the effect of (i) a high GI breakfast (GlyCoBrain intervention study 1) and (ii) a breakfast causing an (isolated) reactive hypoglycaemia (GlyCoBrain intervention study 2) on the course of memory and attention in the postprandial phase.

Read the detailed description

Background Breakfast is commonly considered one of the most important meals of the days. Failure to consume a breakfast, i.e., breakfast skipping, has been related to an increased risk of overweight/obesity or type 2 diabetes in the longer-term, but may also adversely affect cognition and academic performance. Similarly, 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). A recent meta-analysis suggests specific effects for immediate and delayed episodic memory among persons with a better glucose tolerance.

Whilst young adults generally have a better glucose tolerance they are, however, prone to circadian misalignment since their midpoint of sleep (i.e., chronotype) is most delayed. Chronotype is a biological construct mainly influenced by genetics, sex and age. Chronotype tends to shift later from adolescence into early adulthood with the peak of delay around age 20 before moving back to an earlier chronotype. Hence, persons in young adulthood are more likely to have a later chronotype and experience a circadian misalignment between the "inner clock" and social requirements. Such a desynchronization may lead to poorer glucose tolerance and an exaggerated glucose response to a high GI breakfast in individuals with a later chronotype. Our recent research suggests that persons with a later chronotype were similarly vulnerable to both very early and late high GI meals, whereas earlier chronotypes had lower glucose responses to the high GI meal consumed at breakfast. In addition, research from female twins suggests that timing of breakfast has a larger underlying genetic component than timing of dinner, suggesting that consumption of an early breakfast may present a burden for those with a later chronotype. As a result, the cognitive performance of people with a later chronotype could particularly benefit from consuming a low GI breakfast. Current studies also report that later chronotypes delay their meal timing, tend to skip breakfast, are at higher risk to consume larger meals at night than earlier chronotypes and to have less favourable dietary pattern, consuming less protein and vegetables and more sweets, sugar, alcohol and coffee.

Taken together, a later chronotype may make young adults more vulnerable to consume unfavourable breakfasts, i.e. breakfasts with a higher dietary GI, higher energy density and lower micronutrient adequacy. However, to date no study has investigated breakfast habits in relation to chronotype in young adults. Furthermore, it remains to be elucidated which food students choose to account for the necessity of academic performance in preparation for an exam in the morning.

The present study will examine the relevance of breakfast among students in detail and relate this to their chronotype. The observational study will be followed by two nutritional intervention studies only with the earliest and latest chronotypes to examine the effects of high GI breakfast or a breakfast causing a reactive hypoglycaemia on cognitive functions in the early morning.

Hypothesis The hypothesis of the GlyCoBrain observational study is that students with a later chronotype are more likely to consume breakfasts with a higher dietary GI, higher breakfast energy density and lower breakfast micronutrient adequacy. We also postulate that persons with a later chronotype are more prone to consume foods from higher GI sources in preparation for an exam than those with an earlier chronotype.

Aim The aim of the GlyCoBrain observational study is to investigate the breakfast habits of German students aged 18-25 years in relation to their chronotype.

Methods 1 (Participants): The researchers will initially recruit at least 350 students aged 18 to 25 from the University Paderborn who meet the specified inclusion criteria (see Participation Criteria). Recruitment and screening are planned to take place from October 2024 until the end of February 2025. Using the GlyCoBrain observational study, participants with the earliest and latest chronotypes will be identified for subsequent inclusion in the GlyCoBrain intervention studies.

Methods 2 (Methods): In the screening of the GlyCoBrain observational study, participants are first asked to provide general information (gender, age, university schedule, time of last menstruation). Additionally, the criteria for exclusion from participation in the screening of the observational study as well as the intervention studies are queried. This includes information on smoking status, shift work, travel across more than two time zones in the past three months, pregnancy, breastfeeding, medication use, chronic diseases, food intolerances, and allergies. Chronotype, that is defined as the midpoint of the sleep period (mid-time sleep), will be assessed with the Munich ChronoType questionnaire (MCTQ, © Roenneberg and co-workers, 2015). To assess the Chronotype, participants will be asked about their sleep behavior over the past four weeks. Sleep patterns on workdays and free days are inquired about separately to account for differences in sleep duration and timing. This separation is important for accurately adjusting the chronotype calculation, considering differences in sleep duration and timing between these days. In the MCTQ, students will be asked whether they engage in regular work (including study periods), how many days they perform this activity, when they go to bed, how long it takes them to fall asleep, when they wake up, and when they get up.

In addition, the breakfast behavior on exam days will be surveyed in comparison to normal days on which lectures will take place. The questionnaire assumes that the exam is taken at 9 o'clock to simulate a realistic daily routine. The breakfast behavior questionnaire evaluates the extent to which a participants' intake of specific food (29 items), beverages (14 items), meal replacements, or supplements on exam days differs from that on regular days. Participants are also asked where and at what time they eat their breakfast. Further, students will be asked to provide information about any food allergies and details on the food and beverages they bring to the exam.

Habitual intake is assessed by two 24-hour recalls, one collected at the study center at the day of the visit and another one collected remotely at home within 1 week from the visit. The German version of myFood24, a web-based dietary assessment tool, will be used for accurately capturing individuals' dietary intake. In myFood24, students are required to input detailed information about the foods and beverages they have consumed on the day before, including portion sizes and meal types. This data is then analyzed against a food composition database to provide insights into nutrient intake and dietary patterns.

Additionally, body composition will be assessed by Bioimpedance Analysis (BIA, mBCA 515, SECA) to estimate individual percentages of body fat, muscle mass, total body water and extracellular water. Additionally, body weight is measured directly by the medical Body Composition Analyzer (mBCA). Body height is measured using an ultrasound measuring station (seca 287 db). Waist circumference is assessed on the exposed upper body at the midpoint between the lower ribcage and the hip bone. Furthermore, information on physical activity (using a questionnaire from the Study on "Health in Adults in Germany", part of the Robert-Koch-Institut (RKI, Germany)) and screen-time (using a questionnaire previously employed in the Dortmund Nutritional and Anthropometric Longitudinally Designed (DONALD) study, a long-term observational study at University Bonn, Germany) will be collected.

Statistical analyses Multivariable multilevel regression models will be used to examine whether a later chronotype is associated with a less favorable breakfast GI, breakfast food choices and breakfast energy density and nutrient composition. Models will adjust for potential confounders (e.g., sex, age, life-style characteristics, body composition).

Conditions
Healthy, Adult
Keywords
Chronotype, Breakfast, Glyceamic Index, MCTQ, Academic performance, Dietary patterns, Student nutrition, Nutrient composition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06679088
Study groupRoleWhat they receive
students of Paderborn University18 years to 25 years (adult)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Breakfast quality, dietary GI and nutrient composition

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

    Measured: At inclusion into the study and after 6 days

  2. Breakfast food choice in preparation of an exam

    Questionnaire inquiring selected food items, beverages and meal replacements

    Measured: Assessed once at the beginning of the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2024
  2. Study start1 Oct 2024
  3. Primary completion28 Feb 2025
  4. Study completion28 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
350 participants (estimated)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT06679088
Sponsor's protocol ID
BU 1807/8-1
Acronym
GlyCoBrainOb
Status last verified
Nov 2024
First submitted
5 Nov 2024
Last updated
3 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33974128
  • 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.

    PubMed 31935885
  • 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.

    PubMed 30085831
  • 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.

    PubMed 30705391
  • 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.

    PubMed 32884315
  • 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.

    PubMed 30418612
  • 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.

    PubMed 31918985
  • 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.

    PubMed 29723985
  • 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.

    PubMed 22823875
  • 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.

    PubMed 31861810
  • 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.

    PubMed 38605233

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy and Adult, run by Paderborn University at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Breakfast quality, dietary GI and nutrient composition (time frame: At inclusion into the study and after 6 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06679088, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.

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