- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01842022
The Effect of the Glycemic Load of Meals on the Cognition and Mood of Older Adults
The Effect of the Glycemic Load of Meals on the Cognition and Mood of Older Adults With Differences in Glucose Tolerance
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Wales
-
Swansea, Wales, United Kingdom, sa2 8pp
- Psychology, Swansea University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy adults of 45 to 80 years
Exclusion Criteria:
- Type 1 or type 2 diabetes
- Dementia
- Liver disease
- Gastro-intestinal problems
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Better glucose tolerance
Take meals with isomaltulose, sucrose or glucose
|
Isomaltulose sweetened meal will be given to each of four groups who differ in their glucose tolerance
Sucrose sweetened meal will be given to each of four groups who differ in their glucose tolerance
Glucose sweetened meal will be given to each of four groups who differ in their glucose tolerance
|
Other: Better glucose tolerance / Levels fall
Take meals with isomaltulose, sucrose or glucose
|
Isomaltulose sweetened meal will be given to each of four groups who differ in their glucose tolerance
Sucrose sweetened meal will be given to each of four groups who differ in their glucose tolerance
Glucose sweetened meal will be given to each of four groups who differ in their glucose tolerance
|
Other: Poorer tolerance levels remain high
Take meals with isomaltulose, sucrose or glucose
|
Isomaltulose sweetened meal will be given to each of four groups who differ in their glucose tolerance
Sucrose sweetened meal will be given to each of four groups who differ in their glucose tolerance
Glucose sweetened meal will be given to each of four groups who differ in their glucose tolerance
|
Other: Poorer glucose tolerance / Levels fall
Take meals with isomaltulose, sucrose or glucose
|
Isomaltulose sweetened meal will be given to each of four groups who differ in their glucose tolerance
Sucrose sweetened meal will be given to each of four groups who differ in their glucose tolerance
Glucose sweetened meal will be given to each of four groups who differ in their glucose tolerance
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in episodic memory
Time Frame: 30, 105, 180 minutes
|
Episodic memory assessed by asking subjects to recall a list of words
|
30, 105, 180 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in mood
Time Frame: 30, 105, 180 minutes
|
Visual analogues scales used to report mood at six points during study
|
30, 105, 180 minutes
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in reaction Times
Time Frame: 30, 105, 180 minutes
|
1,2,4 and 8 lamps will be monitored and the time taken to extinguish will be measured
|
30, 105, 180 minutes
|
Change in vigilance
Time Frame: 30, 105 and 180 minutes
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David Benton, DSc, Swansea University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DB-0413
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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