The Effects of High and Low GI Breakfasts on Cognitive Performance in Adults With Type 2 Diabetes

January 12, 2010 updated by: University of Leeds

Consumption of a low glycemic index (GI) diet has been shown to improve glycaemic control in type 2 diabetics(Brand-Miller et al., 2003; Jenkins et al., 2008). In addition to the benefits for glycaemic control there is some evidence for acute improvements in cognitive performance after consumption of low GI foods compared with high GI foods in both adults (Benton et al., 2003; Kaplan et al., 2000) and adolescents (Ingwersen et al., 2007; Smith and Foster, 2008).

Given these findings it is possible that low GI focused dietary interventions designed to improve glycaemic control and health outcomes for diabetic patients could also improve the cognitive function of these patients. This is of particular relevance in light of the evidence associating type 2 diabetes with cognitive decrements (Awad et al., 2004; Stewart and Loilitsa 1999; van Harten et al., 2006). To date two studies with type 2 diabetics have reported that a low GI breakfast was associated with increased verbal memory performance compared to a high GI breakfast (Greenwood et al., 2003; Papanikolaou et al. 2006). Further research should investigate the benefit of low GI foods to cognition.

The aim of this study is to examine the effects of high and low glycaemic index breakfast on cognitive performance in adults with type 2 diabetes. Participants will perform a battery of cognitive tests after consuming 3 different breakfasts (high GI, low GI, and water) on 3 different tests days. The participants will be recruited from the general public and from the Leeds Teaching Hospital diabetes clinic.

This research can benefit the development of specific dietary behaviours aimed at reducing diabetes related cognitive decline. This research is part of a PhD funded by the Economic and Social Research Council and the University of Leeds.

Study Overview

Status

Unknown

Conditions

Detailed Description

The study will conform to a randomised mixed design. Both the diabetic experimental group and the control group will take part in three conditions whereby participants will receive a high GI, a low GI, or a water breakfast delivered in a counterbalanced order. Participants will then perform the battery of cognitive tests on 2 occasions throughout the morning; 30 minutes after breakfast and 180 minutes after breakfast. Blood glucose will be measured from capillary finger-prick blood samples using diabetic glucose meters throughout the morning.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS2 9JT
        • Recruiting
        • Institute of Psychological Sciences, University of Leeds, UK
        • Contact:
        • Contact:
        • Principal Investigator:
          • Daniel J Lamport

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants will be recruited from the general population using emails and posters. These will be distributed throughout the University of Leeds, Leeds Metropolitan University, and NHS sites in Leeds. GP's and diabetes specialist doctors and nurses will be asked to inform potential participants of the nature of the study. Ideally spouses, siblings or other close friends/relatives of the experimental group will be recruited for the control group in an attempt to control for education, social class and general lifestyle.

Description

Inclusion Criteria:

  • Able to give informed consent
  • Type 2 diabetes
  • White British or White North American ethnicity and native English speakers
  • Not previously received or currently received subcutaneous insulin as part of their diabetes treatment.
  • Vision sufficiently good to complete the cognitive testing (using glasses and/or lenses).

Exclusion Criteria:

  • Dementia (as indicated using the Mini Mental State Examination <26)
  • Current (or recent i.e. in last 6 months) cigarette smoker
  • Neurological disorder
  • Previous stroke
  • Medication other than diabetes treatment medication that has a direct effect on the brain and is likely to influence cognitive function.

Co-existent diabetic complications will not be considered exclusion criteria unless they result in inability to complete the cognitive testing (e.g. insufficient vision).

These exclusion criteria have been chosen on the basis that these are factors that can affect cognitive performance. Given that the cognitive tests involve learning English words, only participants who have English as their first language can be included because different cognitive processes are used when learning in a non-native language (Wong et al., 2004). Ethnicity can influence glucose regulation and risk of diabetes. Given that part of this research is examining the relationship between glucose regulation and cognition it is important that potential confounds such as ethnicity/genetic propensity to diabetes are controlled for.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Type 2 diabetes
This group contains 25 participants with type 2 diabetes
control group
This group contains 25 participants withput type 2 diabetes. The control group is matched with age, education and lifestyle to the diabetes group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cognitive performance (e.g. memory, attention, reaction time, and problem solving ability).
Time Frame: The primary outcome is measured on three occasions during the three conditions
The primary outcome is measured on three occasions during the three conditions
Blood glucose levels
Time Frame: These are measured during of each of the three conditions
These are measured during of each of the three conditions

Secondary Outcome Measures

Outcome Measure
Time Frame
Subjective sensations of appetite, mood, and mental alertness
Time Frame: These are measured during all three conditions
These are measured during all three conditions
Sleep quality
Time Frame: This is measured prior to each of the three test days and at the screening visit
This is measured prior to each of the three test days and at the screening visit
Stress levels
Time Frame: This is measured prior to each of the three test days and at the screening visit
This is measured prior to each of the three test days and at the screening visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leeds

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Anticipated)

March 1, 2010

Study Completion (Anticipated)

September 1, 2010

Study Registration Dates

First Submitted

January 12, 2010

First Submitted That Met QC Criteria

January 12, 2010

First Posted (Estimate)

January 13, 2010

Study Record Updates

Last Update Posted (Estimate)

January 13, 2010

Last Update Submitted That Met QC Criteria

January 12, 2010

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09/H1305/15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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