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临床试验/NCT06941740
NCT06941740Enrolling By Invitation不适用

Randomized Controlled Nutrition Trial on Reactive Hypoglycaemia on the Course of Memory and Attention Among Young Adults - Relevance of Chronotype

Anette Buyken1 个研究点 分布在 1 个国家目标入组 177 人开始时间: 2025年4月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
177
试验地点
1
主要终点
Difference in immediate memory between low-GI breakfast

研究概览

简要总结

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 index (GI) meals quickly raise blood glucose, potentially causing reactive hypoglycaemia (glucose levels below baseline) and harming cognitive performance, especially in the late postprandial period, particularly after 120 minutes. Young adults may be more sensitive to these cognitive effects due to morning circadian misalignment, as their sleep midpoint (chronotype) is biologically most delayed. Recent research suggests that those with later chronotypes do not display the known circadian decline in glucose tolerance as indicated by equally high glycaemic responses to the same high GI meal in the morning or the evening. Eating breakfast "against the inner clock" may harm glycaemic response, particularly for those with a later chronotype. Those with morning circadian misalignment may also limit breakfast to beverages. Reactive hypoglycaemia commonly follows beverage consumption, especially soft drinks, energy drinks, glucose solutions, and low-GI fruit juices, occurring within 60 minutes after consumption. Later chronotypes may be more prone to reactive hypoglycaemia from drinks, harming cognition. This nutrition trial aims to investigate (I) the effects of breakfast-induced reactive hypoglycaemia on memory and attention in young, healthy, non-obese university students and (II) the relevance of chronotype to hypoglycaemia occurrence. To study reactive hypoglycaemia, a low GI beverage will be used, causing hypoglycaemia despite a low glycaemic response. Two samples will be examined: students of early and late chronotype. Postprandial insulin and cortisol changes will be analyzed, as improved insulin sensitivity and cortisol levels seem to affect cognition. From October 2024 to January 2025, 356 students (ages 18-25) enrolled in the GlyCoBrain Observational study (ID: NCT06679088) and were screened for chronotypes at Paderborn University. Participants with extreme chronotypes will be invited to this crossover study. Power calculations indicated a sample of 88 participants who complete both intervention days. They will consume a low-GI beverage at 9 a.m. causing reactive hypoglycaemia (glucose-fructose-sucrose solution) or a non-hypoglycaemia causing beverage (isomaltulose® solution) and undergo repeated cognitive assessments for the following 180 minutes.

详细描述

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 breakfast on immediate verbal memory only in the late postprandial period. No overall effect on attention in adults was reported, yet advantages for attention in children, adolescents, and young adults were suggested. Mechanisms explaining the time-dependent benefits of a low GL breakfast are not fully understood. The provision of glucose to the brain is currently discussed as a central mechanism linking meal GI/GL to cognition. Glucose is required for cognitive efforts as evidenced by decreases in local extracellular glucose concentrations in the activated brain area. Key neurotransmitter synthesis in the brain needs glucose. Glucose metabolism may influence memory through tryptophan utilization and serotonin concentrations. The memory-enhancing effect of glucose may require relatively constant blood glucose levels in the brain rather than high glucose amounts per se. Hence, whilst high GI foods elicit a transient increase in blood glucose levels, low-GI foods will result in a more sustained and longer-lasting provision of glucose. The late postprandial phase, when cognitive benefits of low GI/GL meals are most noticeable, coincides with the time after reactive hypoglycaemia following a high-GI meal. To disentangle the effects of dietary GI and reactive hypoglycaemia, it is prudent to examine beverages like fruit juices - characterized by a low GI, yet known to induce reactive hypoglycaemia even earlier postprandially. Accordingly, also detrimental effects on cognition should manifest earlier as observed for high-GI breakfast. Since recent work suggests that there may be an optimal blood glucose range for cognitive performance and that this optimal range may differ by cognitive domain, continuous glucose monitoring should be used in addition to the conventional measurement points directly before the cognitive test. However, benefits of low GI/GL breakfast for cognitive function have also been observed without differences in blood glucose levels. This may be attributable to an acutely improved postprandial insulin sensitivity and/or lower cortisol levels elicited by low-GI meals. Accordingly, concomitant examinations of all three factors, i.e. glucose, insulin and cortisol levels seem necessary to disentangle potential mechanisms. The above-mentioned meta-analysis also found greater benefits for individuals with better glucose tolerance, although age may confound this. Studies suggest that young adults with poorer glucose tolerance, even within the healthy range, may be more vulnerable to these effects. While glucose tolerance follows a circadian rhythm, being lowest in the evening due to reduced pancreatic β-cell function and insulin response, circadian misalignment-common among young adults with later chronotypes-can also impair glucose tolerance, even at breakfast, due to decreased insulin sensitivity. This misalignment, often caused by social jetlag, has been linked to obesity, type 2 diabetes, higher blood glucose, HbA1c levels, and an increased risk of depression. It remains unclear whether persons with later chronotypes are more susceptible to reactive hypoglycaemia after breakfast.

Hypothesis

  1. Reactive hypoglycaemia in response to a low-GI beverage impairs memory and attention after approx. 90 minutes
  2. Reactive hypoglycaemia after the consumption of low-GI beverage is more pronounced in healthy persons with a later chronotype
  3. The adverse effect of a low-GI breakfast inducing reactive hypoglycaemia on memory and attention is particularly evident in those with later chronotype Aim This nutrition trial aims to investigate how low-GI beverages induce reactive hypoglycaemia and its effects on memory and attention after meals in postprandial phase. The investigators aim to explore the effects of chronotype in two student samples: those with earlier and later chronotypes. Further, the study investigate the relevance of chronotype for the postprandial course of glucose (including the occurrence of reactive hypoglycaemias), insulin and cortisol levels.

Methodology

Participants Healthy, German-speaking students at Paderborn University (early or late chronotype)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

The study is double-blind, meaning that neither participants nor researchers know which of the two low-GI beverages they are consuming. Beverages will be pre-prepared by staff who are not involved in its provision.

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

  • •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

研究组 & 干预措施

low-GI beverage causing reactive hypoglycaemia

Experimental

low-GI beverage causing reactive hypoglycaemia consisting of 75 g glucose-fructose-sucrose dissolved in 500 ml tap water

干预措施: immediate verbal memory after low glycemic index breakfast inducing no reactive hypoglycaemia (Other)

low-GI beverage causing reactive hypoglycaemia

Experimental

low-GI beverage causing reactive hypoglycaemia consisting of 75 g glucose-fructose-sucrose dissolved in 500 ml tap water

干预措施: immediate verbal memory after low glycemic index breakfast causing reactive hypoglycaemia (Other)

low-GI beverage not inducing reactive hypoglycaemia

Experimental

low-GI beverage not inducing reactive hypoglycaemia consisting of 75 g isomaltulose dissolved in 500 ml tap water

干预措施: immediate verbal memory after low glycemic index breakfast inducing no reactive hypoglycaemia (Other)

low-GI beverage not inducing reactive hypoglycaemia

Experimental

low-GI beverage not inducing reactive hypoglycaemia consisting of 75 g isomaltulose dissolved in 500 ml tap water

干预措施: immediate verbal memory after low glycemic index breakfast causing reactive hypoglycaemia (Other)

结局指标

主要结局

Difference in immediate memory between low-GI breakfast

时间窗: On the first intervention day and after one week from -30 until 150 minutes after intervention focusing on 90 minutes (when reactive hypoglycaemia is expected to manifest)

Computer-assisted cognition test

次要结局

未报告次要终点

研究者

发起方
Anette Buyken
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Anette Buyken

Prof. Dr.

Paderborn University

研究点 (1)

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