Status:
ENROLLING_BY_INVITATION
Effects of Reactive Hypoglycaemia on Cognition in Earlier or Later Chronotypes
Lead Sponsor:
Anette Buyken
Collaborating Sponsors:
Paderborn University
University of Southern Denmark
Conditions:
Healthy
Eligibility:
All Genders
18-25 years
Phase:
NA
Brief Summary
Studies suggest a link between lower postprandial glycaemic response and better cognitive performance in children, adolescents, and young adults, though evidence remains inconclusive. High glycaemic i...
Detailed Description
Studies in young adults indicate beneficial effects of a low-glycaemic index (GI) breakfast on cognitive performance. A meta-analysis of 17 studies revealed the benefits of a low-glycaemic (GL) load b...
Eligibility Criteria
Inclusion
- Participants of GlyCoBrain Observational Study
- Early or late chronotype (approx. lowest and highest quartile)
Exclusion
- Students studying nutritional science or home economics (study programs of the study PI)
- Intermediate chronotypes
- Persons unwilling to abstain from smoking or cannabis use during the intervention period
- Persons unwilling to consume standard evening meals before intervention days
- BMI\>30 kg/m² (diurnal variation in glycaemic control is known to be absent among persons with obesity) and \<18.5 kg/m2 (since underweight is also known to affect glucose homeostasis)
- acute or permanent use of sleep-promoting medications (including herbal preparation):
- medications: melatonin, diphenhydramine, doxylamine
- herbal preparations: hops, St. John's wort, lemon balm, lavender, passionflower, Baldurat, Neurexan, cannabinoids
- Use of psychotropic medications (antidepressants, tranquillizers, 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. ginkgo, 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, haemophilia), eating disorders (e.g., anorexia, binge eating, bulimia), Chronic inflammatory bowel diseases, infectious diseases (HIV, hepatitis), Addiction disorders (e.g., alcohol, drug, or medication dependency)
- Pregnant and breastfeeding individuals
- Shift work or travel in the past 3 months across more than 2 time zones
- students with a pacemaker/defibrillator or cochlear implant
Key Trial Info
Start Date :
April 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
177 Patients enrolled
Trial Details
Trial ID
NCT06941740
Start Date
April 4 2025
End Date
July 31 2027
Last Update
April 27 2025
Active Locations (1)
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1
Paderborn University
Paderborn, North Rhine-Westphalia, Germany, 33098