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

NCT03360604 | Completed

• 1 other identifier: 2017-151-DL
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Diabetes Mellitus, Type 2; Cognitive Impairment

Keywords

glycaemic index; glycaemia; diabetes mellitus; type 2 diabetes

Outcome Measures

Primary Outcomes (4)

• Change in cognitive performance on a Choice Reaction Time task

  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.

  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.

• Change in cognitive performance on a Rapid Visual Information Processing task

  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.

  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.

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

  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.

  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.

• Change in cognitive performance on a Letter Memory Task

  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.

  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.

Secondary Outcomes (5)

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

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.

Dietary Supplement: Low Glycaemic Diet

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.

Dietary Supplement: High Glycaemic Diet

Interventions

Low Glycaemic Diet DIETARY_SUPPLEMENT

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

Low GI diet

High Glycaemic Diet DIETARY_SUPPLEMENT

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

High GI diet

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Matthew Grout: lead

Study Sites (1)

Hugh Sinclair Unit, University of Reading

Reading, Berkshire, RG6 6AL, United Kingdom

Location

Related Publications (8)

• 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.

  PMID: 6259925 BACKGROUND

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

  PMID: 7972154 BACKGROUND

• 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.

  PMID: 18568016 BACKGROUND

• 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.

  PMID: 17224202 BACKGROUND

• 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.

  PMID: 2844076 BACKGROUND

• 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.

  PMID: 21605502 BACKGROUND

• 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.

  PMID: 24184411 BACKGROUND

• 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.

  PMID: 36841444 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Cognitive Dysfunction; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Daniel J Lamport, PhD

  University of Reading

  PRINCIPAL INVESTIGATOR

• Matthew J Grout, PhD

  University of Reading

  STUDY DIRECTOR

• Julie A Lovegrove, PhD

  University of Reading

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are not told which condition they are taking part in during each test day.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctoral Researcher

Model Details: All participants took part in both conditions

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: December 4, 2017
• Study Start: April 4, 2018
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: October 8, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)