The Effect of the Glycemic Load of Meals on the Cognition and Mood of Older Adults

Dementia Clinical Trial

Official title:

The Effect of the Glycemic Load of Meals on the Cognition and Mood of Older Adults With Differences in Glucose Tolerance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01842022
• Other study ID #: DB-0413
• Status: Completed
• Phase: N/A
• First received: April 9, 2013
• Last updated: December 10, 2014
• Start date: September 2011
• Est. completion date: September 2013

Study information

• Verified date: December 2014
• Source: Swansea University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Councils UK
• Study type: Interventional

Clinical Trial Summary

A lower rather than a higher glycemic load (GL) meal has been shown to benefit cognition and mood, however, the data in older adults and those most prone to cognitive dysfunction, is limited and conflicting. One explanation is that the GL of a meal may interact with a person's pre-existing glucose tolerance (GT).

As older adults have a higher incidence of glucose tolerance and are more likely to experience memory problems the present study considers the interaction between the GL of meal in those with better or poorer GT.

The population studied will not have a history of diabetes or dementia. A battery of cognitive tests will be administered after meals sweetened with one of three sugars known to vary in the rate that they release glucose into the blood stream.

Description:

On day one subjects will take an oral glucose tolerance test and will then be divided into four groups depending on their glucose tolerance (how long values remain raised) and the tendency for values to subsequently fall to low values.

On a second occasion 155 healthy older adults, aged 45-80 years, will be randomly assigned to receive either a glucose, sucrose or isomaltulose based meal. All meals are matched on macronutrient composition and differ only in glycemic load. Cognitive performance and mood will be assessed 30, 105 and 180 minutes after breakfast. Measures of memory, attention, reaction times and mood will be taken.

The response to the three meals will be contrasted in those with different glucose profiles on day one

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: September 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 80 Years

Eligibility

Inclusion Criteria:

• Healthy adults of 45 to 80 years

Exclusion Criteria:

• Type 1 or type 2 diabetes

• Dementia

• Liver disease

• Gastro-intestinal problems

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Dementia

Intervention

Dietary Supplement:
• Isomaltulose
Isomaltulose sweetened meal will be given to each of four groups who differ in their glucose tolerance
• Sucrose
Sucrose sweetened meal will be given to each of four groups who differ in their glucose tolerance
• Glucose
Glucose sweetened meal will be given to each of four groups who differ in their glucose tolerance

Locations

Country	Name	City	State
United Kingdom	Psychology, Swansea University	Swansea	Wales

Sponsors (1)

Lead Sponsor	Collaborator
Swansea University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in reaction Times	1,2,4 and 8 lamps will be monitored and the time taken to extinguish will be measured	30, 105, 180 minutes	No
Other	Change in vigilance	Digits will be generated at rate of 100 per minute. Subjects indicate when they see either three odd or three even in a row	30, 105 and 180 minutes	No
Primary	Change in episodic memory	Episodic memory assessed by asking subjects to recall a list of words	30, 105, 180 minutes	No
Secondary	Change in mood	Visual analogues scales used to report mood at six points during study	30, 105, 180 minutes	No