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临床试验/NCT03360604
NCT03360604已完成不适用

Utilizing Glycaemic Index: An Investigation of the Glycaemic Profiles and Cognitive Performance Displayed by Type 2 Diabetics Across the Course of a Day in Low and High Glycaemic Conditions

Matthew Grout2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2018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
已完成
发起方
入组人数
25
试验地点
2
主要终点
Change in cognitive performance on a Choice Reaction Time task

研究概览

简要总结

The current study aims to investigate the effects of two GI diets (low vs. high GI) in a sample (25 participants) that has diet controlled type 2 diabetes. This sample has been chosen as those with diabetes have been shown to suffer with poor glucose tolerance, along with the associated deficits such as compromised cognitive function. Therefore, it is expected that differences produced by the two diets on blood glucose concentrations and cognitive performance will be greater than those previously seen. If this is the case after analyzing the results, it will provide a potential strategy (diet) for improving glucose tolerance and cognitive performance in a vulnerable section of the population.

详细描述

With the introduction of the glycemic index in 1981, which can be defined as a measure of carbohydrate quality within foods, there has been a wealth of research into its' application to cognitive function. This research has been based on the theory that the availability of blood-borne glucose can have an impact on cognitive performance. This is supported by work that has shown that the brain consumes an immense amount of energy relative to the rest of the body, but possesses minute stores of glycogen which it could convert into its main energy source; glucose. This means the brain is reliant on the glucose supplied to it by the blood, which in turn requires the consumption of foods that can be broken down into glucose.

With this in mind, the vast majority of literature has focussed on the acute effects that foods differing in glycemic values may have on cognitive function, and have found many relevant findings such as less cognitive performance decline across the morning for children who eat a low GI breakfast. This could be explained as a low GI breakfast will contain higher quality carbohydrates, or in other words; slower absorbing carbohydrates, which would suggest the brain has access to a steady supply of glucose across the more.

Interesting work in the field of physiology has proposed the presence of a second meal effect, which can be defined as the glycemic index of a meal having an effect on the glycemic response to a subsequent meal. Surprisingly, there are very few pieces of psychology literature that investigate the possibility of a second cognitive meal effect, which is based on the theory that if a meals' GI can affect the glycemic response to a subsequent meal, then it may also have an effect on cognitive function. However, research into this has found some evidence for such an effect.

Although, there has been a wealth of research into the glycemic index as a whole, the methodology varies greatly from study to study. These problems are most evident when looking at the times that cognitive function tests are administered. For research based upon a theory that relies on availability of blood-borne glucose, the times of cognitive testing do not always align themselves with the time points that the glycemic response indicates are ideal testing times.

An initial study by the investigators looked to resolve the current lack of consistency amongst previous research by providing participants with three meals throughout the course of a day, whilst measuring blood glucose via finger prick. The aim was to identify where the biggest differences in blood glucose occur when looking at the results of a sample of 24 healthy participants. The time points identified would then provide information as to when significant differences in cognitive performance throughout the day may be expected.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

盲法说明

Participants are not told which condition they are taking part in during each test day.

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged between 40 and 70 years of age.
  • Willing to participate in the entire study.
  • Male of female (not pregnant).
  • Currently have type 2 diabetes mellitus.

排除标准

  • Presence of any food intolerances or allergies.
  • Being an elite athlete (very intense exercise more than 3 times a week).
  • A history of drug or alcohol abuse.
  • Presence of cancer.
  • Presence of clinically diagnosed depression.

研究组 & 干预措施

Low GI diet

Experimental

This diet consists of three meals (breakfast, lunch, snack) which all have a low glycaemic index. This is the Low Glycaemic Diet intervention.

干预措施: Low Glycaemic Diet (Dietary Supplement)

High GI diet

Experimental

This diet consists of three meals (breakfast, lunch, snack) which all have a high glycaemic index. This is the High Glycaemic Diet intervention.

干预措施: High Glycaemic Diet (Dietary Supplement)

结局指标

主要结局

Change in cognitive performance on a Choice Reaction Time task

时间窗: This test lasts 3 minutes. Participants are tested 9 times on each test day. There are two test days. Giving a total of 18 times, or approximately 54 minutes of performing this task across the entire study.

Specifically, the number of errors and the reaction times of participants are recorded by the software that runs this task (E prime) as it is performed. The number of errors and the mean reaction times are later statistically assessed in SPSS.

Change in cognitive performance on a Rapid Visual Information Processing task

时间窗: This test lasts 3 minutes. Participants are tested 9 times on each test day. There are two test days. Giving a total of 18 times, or approximately 54 minutes of performing this task across the entire study.

Specifically, the number of errors and the reaction times of participants are recorded by the software that runs this task (E prime) as it is performed. The number of errors and the mean reaction times are later statistically assessed in SPSS.

Change in cognitive performance on a Letter Memory Task

时间窗: This test lasts 5 minutes. Participants are tested 9 times on each test day. There are two test days. Giving a total of 18 times, or approximately 90 minutes of performing this task across the entire study.

Specifically, the number of errors and the reaction times of participants are recorded by the software that runs this task (E prime) as it is performed. The number of errors and the mean reaction times are later statistically assessed in SPSS.

Change in cognitive performance on a combined Choice Reaction Time and Rapid Visual Information Processing task

时间窗: This test lasts 5 minutes. Participants are tested 9 times on each test day. There are two test days. Giving a total of 18 times, or approximately 90 minutes of performing this task across the entire study.

Specifically, the number of errors and the reaction times of participants are recorded by the software that runs this task (E prime) as it is performed. The number of errors and the mean reaction times are later statistically assessed in SPSS.

次要结局

  • Sleepiness(This takes approximately 30 seconds to complete. Participants were tested six times a day. There were two test days. Giving a total of 12 times, or approximately 6 minutes overall.)
  • Mood (alertness, anxiety and contentment) measured by Bond & Lader (1974) Visual Analogue Scale(This was measured 6 times a day (every 90 minutes starting at 0 minutes/baseline), giving a total of 12 times. Each time lasts approximately 5 minutes, giving a total of 60 minutes overall. Data will be reported for the duration of this 3 year PhD award.)
  • Fullness(This takes approximately 30 seconds to complete. Participants were tested six times a day. There were two test days. Giving a total of 12 times, or approximately 6 minutes overall.)
  • Glycaemic profile(This is measured continuously throughout each day. Each day last approximately 9 hours. There are two test days. Giving a total of 18 hours of continuous glucose monitoring per participant.)
  • Hunger(This takes approximately 30 seconds to complete. Participants were tested six times a day. There were two test days. Giving a total of 12 times, or approximately 6 minutes overall.)

研究者

发起方
Matthew Grout
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Matthew Grout

Doctoral Researcher

University of Reading

研究点 (2)

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