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Clinical Trials in Germany / NCT06679088
Enrolling by invitation Observational

GlyCoBrain Observational Study

NCT06679088 · tracked via the Priya Life Science Germany tracker
Sponsor
Paderborn University
Phase
Observational
Started
2024-10-01
Last updated
2025-04-03

Condition(s) studied

HealthyAdult

Study 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. 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
25 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Students at Paderborn University aged between 18 and 25 years * Proficient in the German language because all questionnaires are in German. Exclusion Criteria: * 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 * Shift work or travel in the past 3 months across more than 2 time zones * students with a pacemaker/defibrillator

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Paderborn University Paderborn North-Rhine-Westfalia

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06679088 on ClinicalTrials.gov ↗ ← All trials in Germany