Type 2 DiabetesNCT01047813
The Effects of High and Low GI Breakfasts on Cognitive Performance in Adults With Type 2 Diabetes
An observational study of Type 2 Diabetes, run by University of Leeds at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2009to Sep 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Institute of Psychological Sciences, University of Leeds, UK
Leeds, West Yorkshire, LS2 9JT
Daniel J Lamport, 07792362588 ext. +44, d.j.lamport02@leeds.ac.uk
Louise Dye, Professor, 01133435753 ext. +44, l.dye@leeds.ac.uk
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Keywords
- Cognitive performance, Type 2 diabetes, Blood glucose
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Cognitive performance (e.g. memory, attention, reaction time, and problem solving ability).
Measured: The primary outcome is measured on three occasions during the three conditions
Blood glucose levels
Measured: These are measured during of each of the three conditions
Secondary outcomes (3)
Subjective sensations of appetite, mood, and mental alertness
Measured: These are measured during all three conditions
Sleep quality
Measured: This is measured prior to each of the three test days and at the screening visit
Stress levels
Measured: This is measured prior to each of the three test days and at the screening visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startSep 2009
- Primary completionMar 2010 (estimated)
- Study completionSep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01047813
- Sponsor's protocol ID
- 09/H1305/15
- Status last verified
- Jul 2009
- First submitted
- 12 Jan 2010
- Last updated
- 13 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Awad N, Gagnon M, Messier C. The relationship between impaired glucose tolerance, type 2 diabetes, and cognitive function. J Clin Exp Neuropsychol. 2004 Nov;26(8):1044-80. doi: 10.1080/13803390490514875.
PubMed 15590460Benton D, Ruffin MP, Lassel T, Nabb S, Messaoudi M, Vinoy S, Desor D, Lang V. The delivery rate of dietary carbohydrates affects cognitive performance in both rats and humans. Psychopharmacology (Berl). 2003 Feb;166(1):86-90. doi: 10.1007/s00213-002-1334-5. Epub 2002 Dec 12.
PubMed 12488949Brand-Miller J, Hayne S, Petocz P, Colagiuri S. Low-glycemic index diets in the management of diabetes: a meta-analysis of randomized controlled trials. Diabetes Care. 2003 Aug;26(8):2261-7. doi: 10.2337/diacare.26.8.2261.
PubMed 12882846Greenwood CE, Kaplan RJ, Hebblethwaite S, Jenkins DJ. Carbohydrate-induced memory impairment in adults with type 2 diabetes. Diabetes Care. 2003 Jul;26(7):1961-6. doi: 10.2337/diacare.26.7.1961.
PubMed 12832296Ingwersen 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.
PubMed 17224202Jenkins DJ, Kendall CW, McKeown-Eyssen G, Josse RG, Silverberg J, Booth GL, Vidgen E, Josse AR, Nguyen TH, Corrigan S, Banach MS, Ares S, Mitchell S, Emam A, Augustin LS, Parker TL, Leiter LA. Effect of a low-glycemic index or a high-cereal fiber diet on type 2 diabetes: a randomized trial. JAMA. 2008 Dec 17;300(23):2742-53. doi: 10.1001/jama.2008.808.
PubMed 19088352Kaplan RJ, Greenwood CE, Winocur G, Wolever TM. Cognitive performance is associated with glucose regulation in healthy elderly persons and can be enhanced with glucose and dietary carbohydrates. Am J Clin Nutr. 2000 Sep;72(3):825-36. doi: 10.1093/ajcn/72.3.825.
PubMed 10966906Papanikolaou Y, Palmer H, Binns MA, Jenkins DJ, Greenwood CE. Better cognitive performance following a low-glycaemic-index compared with a high-glycaemic-index carbohydrate meal in adults with type 2 diabetes. Diabetologia. 2006 May;49(5):855-62. doi: 10.1007/s00125-006-0183-x. Epub 2006 Mar 1.
PubMed 16508776Smith MA, Foster JK. The impact of a high versus a low glycaemic index breakfast cereal meal on verbal episodic memory in healthy adolescents. Nutr Neurosci. 2008 Oct;11(5):219-27. doi: 10.1179/147683008X344110.
PubMed 18782482Stewart R, Liolitsa D. Type 2 diabetes mellitus, cognitive impairment and dementia. Diabet Med. 1999 Feb;16(2):93-112. doi: 10.1046/j.1464-5491.1999.00027.x.
PubMed 10229302van Harten B, de Leeuw FE, Weinstein HC, Scheltens P, Biessels GJ. Brain imaging in patients with diabetes: a systematic review. Diabetes Care. 2006 Nov;29(11):2539-48. doi: 10.2337/dc06-1637. No abstract available.
PubMed 17065699Wong PC, Parsons LM, Martinez M, Diehl RL. The role of the insular cortex in pitch pattern perception: the effect of linguistic contexts. J Neurosci. 2004 Oct 13;24(41):9153-60. doi: 10.1523/JNEUROSCI.2225-04.2004.
PubMed 15483134Lamport DJ, Dye L, Mansfield MW, Lawton CL. Acute glycaemic load breakfast manipulations do not attenuate cognitive impairments in adults with type 2 diabetes. Clin Nutr. 2013 Apr;32(2):265-72. doi: 10.1016/j.clnu.2012.07.008. Epub 2012 Aug 15.
PubMed 22959621
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of High and Low GI Breakfasts on Cognitive Performance in Adults With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01047813
- Acronym / sponsor ID
- 09/H1305/15
- Conditions
- Type 2 Diabetes
- Keywords
- Cognitive performance, Type 2 diabetes, Blood glucose
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Mar 2010 (estimated)
- Study completion
- Sep 2010 (estimated)
- First posted
- 13 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Blood glucose levels
Time frame: These are measured during of each of the three conditions
3 secondary outcomes
Subjective sensations of appetite, mood, and mental alertness
Time frame: 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
Stress levels
Time frame: This is measured prior to each of the three test days and at the screening visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2010.
- Background: PubMed 15590460Awad N, Gagnon M, Messier C. The relationship between impaired glucose tolerance, type 2 diabetes, and cognitive function. J Clin Exp Neuropsychol. 2004 Nov;26(8):1044-80. doi: 10.1080/13803390490514875.
- Background: PubMed 12488949Benton D, Ruffin MP, Lassel T, Nabb S, Messaoudi M, Vinoy S, Desor D, Lang V. The delivery rate of dietary carbohydrates affects cognitive performance in both rats and humans. Psychopharmacology (Berl). 2003 Feb;166(1):86-90. doi: 10.1007/s00213-002-1334-5. Epub 2002 Dec 12.
- Background: PubMed 12882846Brand-Miller J, Hayne S, Petocz P, Colagiuri S. Low-glycemic index diets in the management of diabetes: a meta-analysis of randomized controlled trials. Diabetes Care. 2003 Aug;26(8):2261-7. doi: 10.2337/diacare.26.8.2261.
- Background: PubMed 12832296Greenwood CE, Kaplan RJ, Hebblethwaite S, Jenkins DJ. Carbohydrate-induced memory impairment in adults with type 2 diabetes. Diabetes Care. 2003 Jul;26(7):1961-6. doi: 10.2337/diacare.26.7.1961.
- Background: PubMed 17224202Ingwersen 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.
- Background: PubMed 19088352Jenkins DJ, Kendall CW, McKeown-Eyssen G, Josse RG, Silverberg J, Booth GL, Vidgen E, Josse AR, Nguyen TH, Corrigan S, Banach MS, Ares S, Mitchell S, Emam A, Augustin LS, Parker TL, Leiter LA. Effect of a low-glycemic index or a high-cereal fiber diet on type 2 diabetes: a randomized trial. JAMA. 2008 Dec 17;300(23):2742-53. doi: 10.1001/jama.2008.808.
- Background: PubMed 10966906Kaplan RJ, Greenwood CE, Winocur G, Wolever TM. Cognitive performance is associated with glucose regulation in healthy elderly persons and can be enhanced with glucose and dietary carbohydrates. Am J Clin Nutr. 2000 Sep;72(3):825-36. doi: 10.1093/ajcn/72.3.825.
- Background: PubMed 16508776Papanikolaou Y, Palmer H, Binns MA, Jenkins DJ, Greenwood CE. Better cognitive performance following a low-glycaemic-index compared with a high-glycaemic-index carbohydrate meal in adults with type 2 diabetes. Diabetologia. 2006 May;49(5):855-62. doi: 10.1007/s00125-006-0183-x. Epub 2006 Mar 1.
- Background: PubMed 18782482Smith MA, Foster JK. The impact of a high versus a low glycaemic index breakfast cereal meal on verbal episodic memory in healthy adolescents. Nutr Neurosci. 2008 Oct;11(5):219-27. doi: 10.1179/147683008X344110.
- Background: PubMed 10229302Stewart R, Liolitsa D. Type 2 diabetes mellitus, cognitive impairment and dementia. Diabet Med. 1999 Feb;16(2):93-112. doi: 10.1046/j.1464-5491.1999.00027.x.
- Background: PubMed 17065699van Harten B, de Leeuw FE, Weinstein HC, Scheltens P, Biessels GJ. Brain imaging in patients with diabetes: a systematic review. Diabetes Care. 2006 Nov;29(11):2539-48. doi: 10.2337/dc06-1637. No abstract available.
- Background: PubMed 15483134Wong PC, Parsons LM, Martinez M, Diehl RL. The role of the insular cortex in pitch pattern perception: the effect of linguistic contexts. J Neurosci. 2004 Oct 13;24(41):9153-60. doi: 10.1523/JNEUROSCI.2225-04.2004.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by University of Leeds at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel J Lamport (07792362588 ext. +44, d.j.lamport02@leeds.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01047813, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2010; AzTrials last refreshed its copy on 6 Nov 2026.