NCT01842022

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
155

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2013

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 29, 2013

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

December 11, 2014

Status Verified

December 1, 2014

Enrollment Period

1.7 years

First QC Date

April 9, 2013

Last Update Submit

December 10, 2014

Conditions

Dementia

Keywords

Glycemic loadmemorymood

Outcome Measures

Primary Outcomes (1)

  • Change in episodic memory

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

    30, 105, 180 minutes

Secondary Outcomes (1)

  • Change in mood

    30, 105, 180 minutes

Other Outcomes (2)

  • Change in reaction Times

    30, 105, 180 minutes

  • Change in vigilance

    30, 105 and 180 minutes

Study Arms (4)

Better glucose tolerance

OTHER

Take meals with isomaltulose, sucrose or glucose

Dietary Supplement: IsomaltuloseDietary Supplement: SucroseDietary Supplement: Glucose

Better glucose tolerance / Levels fall

OTHER

Take meals with isomaltulose, sucrose or glucose

Dietary Supplement: IsomaltuloseDietary Supplement: SucroseDietary Supplement: Glucose

Poorer tolerance levels remain high

OTHER

Take meals with isomaltulose, sucrose or glucose

Dietary Supplement: IsomaltuloseDietary Supplement: SucroseDietary Supplement: Glucose

Poorer glucose tolerance / Levels fall

OTHER

Take meals with isomaltulose, sucrose or glucose

Dietary Supplement: IsomaltuloseDietary Supplement: SucroseDietary Supplement: Glucose

Interventions

IsomaltuloseDIETARY_SUPPLEMENT

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

Better glucose toleranceBetter glucose tolerance / Levels fallPoorer glucose tolerance / Levels fallPoorer tolerance levels remain high
SucroseDIETARY_SUPPLEMENT

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

Better glucose toleranceBetter glucose tolerance / Levels fallPoorer glucose tolerance / Levels fallPoorer tolerance levels remain high
GlucoseDIETARY_SUPPLEMENT

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

Better glucose toleranceBetter glucose tolerance / Levels fallPoorer glucose tolerance / Levels fallPoorer tolerance levels remain high

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adults of 45 to 80 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychology, Swansea University

Swansea, Wales, sa2 8pp, United Kingdom

Location

MeSH Terms

Conditions

Dementia

Interventions

isomaltuloseSucroseGlucose

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugarsHexosesMonosaccharides

Study Officials

  • David Benton, DSc

    Swansea University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychology

Study Record Dates

First Submitted

April 9, 2013

First Posted

April 29, 2013

Study Start

September 1, 2011

Primary Completion

May 1, 2013

Study Completion

September 1, 2013

Last Updated

December 11, 2014

Record last verified: 2014-12

Locations

GB(1)