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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01047813
• Other study ID #: 09/H1305/15
• Status: Recruiting
• Phase: N/A
• First received: January 12, 2010
• Last updated: January 12, 2010
• Start date: September 2009
• Est. completion date: September 2010

Study information

• Verified date: July 2009
• Source: University of Leeds
• Contact: Daniel J Lamport
• Phone: 07792362588
• Email: d.j.lamport02[@]leeds.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Locations

Country	Name	City	State
United Kingdom	Institute of Psychological Sciences, University of Leeds, UK	Leeds	West Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Leeds

Country where clinical trial is conducted

United Kingdom, 

References & Publications (12)

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. Review. — View Citation

Benton 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. Epub 2002 Dec 12. — View Citation

Brand-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. — View Citation

Greenwood 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. — View Citation

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. Epub 2007 Jan 16. — View Citation

Jenkins 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. — View Citation

Kaplan 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. — View Citation

Papanikolaou 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. Epub 2006 Mar 1. — View Citation

Smith 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. — View Citation

Stewart R, Liolitsa D. Type 2 diabetes mellitus, cognitive impairment and dementia. Diabet Med. 1999 Feb;16(2):93-112. Review. — View Citation

van 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. Review. — View Citation

Wong 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive performance (e.g. memory, attention, reaction time, and problem solving ability).		The primary outcome is measured on three occasions during the three conditions	No
Primary	Blood glucose levels		These are measured during of each of the three conditions	No
Secondary	Subjective sensations of appetite, mood, and mental alertness		These are measured during all three conditions	No
Secondary	Sleep quality		This is measured prior to each of the three test days and at the screening visit	No
Secondary	Stress levels		This is measured prior to each of the three test days and at the screening visit	No