Utilizing Glycaemic Index: An Investigation of the Glycaemia and Cognition in Type 2 Diabetes

NCT ID: NCT03360604

Last Updated: 2019-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-04

Study Completion Date

2018-12-01

Brief Summary

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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.

Detailed Description

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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.

A second study fed a larger healthy sample (40 participants) the same meals, but also included a cognitive task battery. Results from the blood glucose concentrations supported results from study 1, with the two diets producing measureable differences in the glycaemic profiles produced across a test day. This is another step into potentially producing a diet that could promote healthy glucose regulation and cognitive function.

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.

Conditions

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Diabetes Mellitus, Type 2 Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

All participants took part in both conditions
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

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

Study Groups

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Low GI diet

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

Group Type EXPERIMENTAL

Low Glycaemic Diet

Intervention Type DIETARY_SUPPLEMENT

This intervention is a diet consisting of a Low GI breakfast, lunch and snack meal.

High GI diet

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

Group Type EXPERIMENTAL

High Glycaemic Diet

Intervention Type DIETARY_SUPPLEMENT

This intervention is a diet consisting of a High GI breakfast, lunch and snack meal.

Interventions

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Low Glycaemic Diet

This intervention is a diet consisting of a Low GI breakfast, lunch and snack meal.

Intervention Type DIETARY_SUPPLEMENT

High Glycaemic Diet

This intervention is a diet consisting of a High GI breakfast, lunch and snack meal.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Matthew Grout

OTHER

Sponsor Role lead

Responsible Party

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Matthew Grout

Doctoral Researcher

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Daniel J Lamport, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Reading

Matthew J Grout, PhD

Role: STUDY_DIRECTOR

University of Reading

Julie A Lovegrove, PhD

Role: STUDY_CHAIR

University of Reading

Locations

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Hugh Sinclair Unit, University of Reading

Reading, Berkshire, United Kingdom

Site Status

Countries

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United Kingdom

References

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Jenkins DJ, Wolever TM, Taylor RH, Barker H, Fielden H, Baldwin JM, Bowling AC, Newman HC, Jenkins AL, Goff DV. Glycemic index of foods: a physiological basis for carbohydrate exchange. Am J Clin Nutr. 1981 Mar;34(3):362-6. doi: 10.1093/ajcn/34.3.362.

Reference Type BACKGROUND
PMID: 6259925 (View on PubMed)

Amiel SA. Nutrition of the brain: macronutrient supply. Proc Nutr Soc. 1994 Jul;53(2):401-5. doi: 10.1079/pns19940045. No abstract available.

Reference Type BACKGROUND
PMID: 7972154 (View on PubMed)

Gomez-Pinilla F. Brain foods: the effects of nutrients on brain function. Nat Rev Neurosci. 2008 Jul;9(7):568-78. doi: 10.1038/nrn2421.

Reference Type BACKGROUND
PMID: 18568016 (View on PubMed)

Ingwersen J, Defeyter MA, Kennedy DO, Wesnes KA, Scholey AB. A low glycaemic index breakfast cereal preferentially prevents children's cognitive performance from declining throughout the morning. Appetite. 2007 Jul;49(1):240-4. doi: 10.1016/j.appet.2006.06.009. Epub 2007 Jan 16.

Reference Type BACKGROUND
PMID: 17224202 (View on PubMed)

Wolever TM, Jenkins DJ, Ocana AM, Rao VA, Collier GR. Second-meal effect: low-glycemic-index foods eaten at dinner improve subsequent breakfast glycemic response. Am J Clin Nutr. 1988 Oct;48(4):1041-7. doi: 10.1093/ajcn/48.4.1041.

Reference Type BACKGROUND
PMID: 2844076 (View on PubMed)

Lamport DJ, Hoyle E, Lawton CL, Mansfield MW, Dye L. Evidence for a second meal cognitive effect: glycaemic responses to high and low glycaemic index evening meals are associated with cognition the following morning. Nutr Neurosci. 2011 Mar;14(2):66-71. doi: 10.1179/1476830511Y.0000000002.

Reference Type BACKGROUND
PMID: 21605502 (View on PubMed)

Lamport DJ, Lawton CL, Mansfield MW, Moulin CA, Dye L. Type 2 diabetes and impaired glucose tolerance are associated with word memory source monitoring recollection deficits but not simple recognition familiarity deficits following water, low glycaemic load, and high glycaemic load breakfasts. Physiol Behav. 2014 Jan 30;124:54-60. doi: 10.1016/j.physbeh.2013.10.033. Epub 2013 Oct 30.

Reference Type BACKGROUND
PMID: 24184411 (View on PubMed)

Grout M, Lovegrove JA, Lamport DJ. A multimeal paradigm producing a low glycemic response is associated with modest cognitive benefits relative to a high glycemic response: a randomized, crossover trial in patients with type 2 diabetes. Am J Clin Nutr. 2023 May;117(5):859-869. doi: 10.1016/j.ajcnut.2023.02.017. Epub 2023 Feb 24.

Reference Type DERIVED
PMID: 36841444 (View on PubMed)

Other Identifiers

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2017-151-DL

Identifier Type: -

Identifier Source: org_study_id

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