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

Primary Purpose

Dementia

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Isomaltulose

Sucrose

Glucose

About this trial

This is an interventional basic science trial for Dementia focused on measuring Glycemic load, memory, mood

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy adults of 45 to 80 years

Exclusion Criteria:

Type 1 or type 2 diabetes
Dementia
Liver disease
Gastro-intestinal problems

Sites / Locations

Psychology, Swansea University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Arm Label

Better glucose tolerance

Better glucose tolerance / Levels fall

Poorer tolerance levels remain high

Poorer glucose tolerance / Levels fall

Arm Description

Take meals with isomaltulose, sucrose or glucose

Outcomes

Primary Outcome Measures

Change in episodic memory

Episodic memory assessed by asking subjects to recall a list of words

Secondary Outcome Measures

Change in mood

Visual analogues scales used to report mood at six points during study

Full Information

NCT ID

NCT01842022

First Posted

April 9, 2013

Last Updated

December 10, 2014

Sponsor

Swansea University

1. Study Identification

Unique Protocol Identification Number

NCT01842022

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

September 2011 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Swansea University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dementia

Keywords

Glycemic load, memory, mood

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

155 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Better glucose tolerance

Arm Type

Other

Arm Description

Take meals with isomaltulose, sucrose or glucose

Arm Title

Better glucose tolerance / Levels fall

Arm Type

Other

Arm Description

Take meals with isomaltulose, sucrose or glucose

Arm Title

Poorer tolerance levels remain high

Arm Type

Other

Arm Description

Take meals with isomaltulose, sucrose or glucose

Arm Title

Poorer glucose tolerance / Levels fall

Arm Type

Other

Arm Description

Take meals with isomaltulose, sucrose or glucose

Intervention Type

Dietary Supplement

Intervention Name(s)

Isomaltulose

Intervention Description

Isomaltulose sweetened meal will be given to each of four groups who differ in their glucose tolerance

Intervention Type

Dietary Supplement

Intervention Name(s)

Sucrose

Intervention Description

Sucrose sweetened meal will be given to each of four groups who differ in their glucose tolerance

Intervention Type

Dietary Supplement

Intervention Name(s)

Glucose

Intervention Description

Glucose sweetened meal will be given to each of four groups who differ in their glucose tolerance

Primary Outcome Measure Information:

Title

Change in episodic memory

Description

Episodic memory assessed by asking subjects to recall a list of words

Time Frame

30, 105, 180 minutes

Secondary Outcome Measure Information:

Title

Change in mood

Description

Visual analogues scales used to report mood at six points during study

Time Frame

30, 105, 180 minutes

Other Pre-specified Outcome Measures:

Title

Change in reaction Times

Description

1,2,4 and 8 lamps will be monitored and the time taken to extinguish will be measured

Time Frame

30, 105, 180 minutes

Title

Change in vigilance

Description

Digits will be generated at rate of 100 per minute. Subjects indicate when they see either three odd or three even in a row

Time Frame

30, 105 and 180 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy adults of 45 to 80 years Exclusion Criteria: Type 1 or type 2 diabetes Dementia Liver disease Gastro-intestinal problems

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Benton, DSc

Organizational Affiliation

Swansea University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Psychology, Swansea University

City

Swansea

State/Province

Wales

ZIP/Postal Code

sa2 8pp

Country

United Kingdom

12. IPD Sharing Statement

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

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