Effects of Breakfast Glycaemic Index on Cognition in Earlier or Later Chronotypes.

NCT06916039 | Enrolling By Invitation DMC

• 1 other identifier: BU 1807/8-1-1
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

Brief Summary

High glycaemic index (GI) breakfasts 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). Previous research indicates that breakfast GI influences cognition in young adults, but many studies were too short to capture late postprandial effects. However, young adults may be particularly responsive to these adverse effects on cognition since they are prone to experience circadian misalignment in the morning due to the fact that their midpoint of sleep (i.e., chronotype) is biologically most delayed. Our recent research suggests that persons with later chronotypes do not display the known circadian decline in glucose tolerance as evidenced by equally high glycaemic responses to the identical high GI meal consumed in the morning or the evening. Hence, consuming an early breakfast "against the inner clock" may negatively affect glycaemic response particularly among persons with a later chronotype. Whether this vulnerability for persons with a later chronotype may extend to effects on cognition has not been examined. Thus, the main objective of this controlled nutrition trial is to analyze the effects of a high versus a low GI beverage as a breakfast on subsequent memory and attention until 180 minutes after breakfast among young healthy university students. This will be examined in two samples, i.e. students with an earlier and with a later chronotype. Accordingly, our study will allow us to explore the relevance of chronotype for (i) the postprandial course of glucose levels and (ii) the course of memory and attention per se in the postprandial phase. In preparation for the present study, at Paderborn University 356 students (aged 18-25) were enrolled between October 2024 and January 2025 in the GlyCoBrain Observational study (ID: NCT06679088) and were screened for their chronotypes. From these, persons with the earliest and latest chronotype will be invited to participate in the present cross-over designed study. It is planned that overall 88 persons will complete both intervention days consuming either a high GI or a low GI breakfast at 9:00 a.m. and undergoing repeated assessment of cognitive performance during the subsequent 180 minutes.

Conditions

Healthy

Keywords

chronotype; breakfast; glycemic index; attention; cognition; memory; body composition; continous glucose monitoring; MCTQ

Outcome Measures

Primary Outcomes (1)

• Difference in immediate verbal memory

  Difference in immediate verbal memory between high and low GI breakfasts at 150-180 minutes (i.e., in the late postprandial phase)

  150-180 minutes

Study Arms (2)

high glycemic index breakfast

EXPERIMENTAL

1\. a high GI beverage (i.e. "glucose beverage") consisting of 75 g glucose dissolved in 500 ml tap water

Other: immediate verbal memory after high GI breakfast; Other: immediate verbal memory after low glycemic index breakfast

low glycemic index breakfast

EXPERIMENTAL

2\. a low GI beverage inducing no reactive hypoglycaemia ("isomaltulose® beverage") consisting of 75 g isomaltulose dissolved in 500 ml tap water

Other: immediate verbal memory after high GI breakfast; Other: immediate verbal memory after low glycemic index breakfast

Interventions

immediate verbal memory after high GI breakfast OTHER

Difference in immediate verbal memory after high GI breakfast at 150-180 minutes (i.e., in the late postprandial phase)

high glycemic index breakfast; low glycemic index breakfast

immediate verbal memory after low glycemic index breakfast OTHER

Difference in immediate verbal memory after low GI breakfast at 150-180 minutes (i.e., in the late postprandial phase)

high glycemic index breakfast; low glycemic index breakfast

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants of GlyCoBrain Observational Study
• Early or late chronotype (approx. lowest and highest quartile)

You may not qualify if:

• Students studying nutritional science and 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 meal prior to 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, 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), Chronic inflammatory bowel diseases, infectious diseases (HIV, hepatitis), Addiction disorders (e.g., alcohol, drug, or medication dependency)

Sponsors & Collaborators

• Anette Buyken: lead
• Paderborn University: collaborator
• University of Southern Denmark: collaborator

Study Sites (1)

Paderborn University

Paderborn, North Rhine-Westphalia, 33098, Germany

Location

Related Publications (23)

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Study Officials

• Anette E Buyken, Prof. Dr.

  Paderborn University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study is double-blind, meaning that neither participants nor researchers know whether the consumed beverage has a high or low GI. Beverages will be pre-prepared by staff not involved in its provision.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Anette Buyken

Model Details: It is estimated that a maximum of 177 participants will need to be invited, to obtain full data sets from 44 participants of an earlier chronotype and 44 of a later chronotype each completing the cross-over designed intervention study. The intervention will consists of consumption of a carbohydrate-rich breakfast as a high-GI beverage at 8:40 p.m or a low-GI beverage at the same time. Participants will be randomly assigned to one of two groups stratified by chronotype: intake of a beverage with a high GI or low GI on day 1. On day 7, the meal of the high GI or low GI meal is switched. The trial is a two-arm cross-over study in which each participant serves as his / her own control to account for interindividual variations in diurnal glycaemic responses and cognitive performance.

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 8, 2025
• Study Start: April 4, 2025
• Primary Completion: March 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: April 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)