NCT01427231

Brief Summary

The objective of the current study is to determine the acute effect of a glucose drink and a sacharose drink compared to a placebo on cognitive performance in elderly with light memory complaints. The investigators expect that the sugar containing drinks will improve memory and attentional functions. Furthermore, blood glucose response will be measured.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2011

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

August 26, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

March 21, 2012

Status Verified

March 1, 2012

Enrollment Period

4 months

First QC Date

August 26, 2011

Last Update Submit

March 20, 2012

Conditions

Keywords

Cognitive performanceAttentionMemoryGlucoseSacharoseElderlyMemory complaints

Outcome Measures

Primary Outcomes (1)

  • Performance on the paired associate recall test

    Cognitive performance will be assessed by several sensitive tests. Power is calculated on the paired associate recall test, but also several other cognitive performance test focusing on memory, attention and reaction time will be performed

    cognitive tests will start 15 minutes after ingestion of the intervention product

Secondary Outcomes (3)

  • Mood

    within 15 minutes after consuming the test drink and after completing the cognitive tests (within 90 minutes after consuming the test drink)

  • Blood glucose response

    from baseline till 90 minutes after consuming the drink

  • Plasma insulin levels

    At t= -15 minutes, before consuming the test drink

Study Arms (3)

Drink with 50 g glucose

ACTIVE COMPARATOR

The glucose drink contains 50 g of glucose soluted in 250 ml of water and lemon juice.

Dietary Supplement: glucose

Drink with 100 gram of sacharose

ACTIVE COMPARATOR

The sacharose drink contains 100 g of sacharose soluted in 250 ml of water and lemon juice.

Dietary Supplement: sacharose

Placebo with sweeteners

PLACEBO COMPARATOR

The placebo contains a mixture of artificial sweeteners in order to have the same sweetness and appearance of the test drinks (the glucose drink and the sacharose drink).

Dietary Supplement: Placebo

Interventions

glucoseDIETARY_SUPPLEMENT

The effect of a glucose solution on cognitive performance will be measured.

Also known as: Sucrose, sugar.
Drink with 50 g glucose
sacharoseDIETARY_SUPPLEMENT

The effect of a sacharose solution on cognitive performance will be measured.

Drink with 100 gram of sacharose
PlaceboDIETARY_SUPPLEMENT

The effect of a placebo drink with sweeteners on cognitive performance will be measured.

Placebo with sweeteners

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Men and women
  • years and older
  • Memory complaints

You may not qualify if:

  • Type I or II diabetes
  • Parkinson disease
  • MMSE \< 25 (to exclude cognitively impaired subjects
  • CES-D \> 16 (to exclude depressive subjects)
  • Pharmacological antidepressives or medication for dementia
  • Liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wageningen University

Wageningen, Gelderland, 6703 HD, Netherlands

Location

MeSH Terms

Conditions

Psychological Well-Being

Interventions

GlucoseSucroseSugars

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesCarbohydratesDisaccharidesOligosaccharidesPolysaccharides

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

August 26, 2011

First Posted

September 1, 2011

Study Start

August 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

March 21, 2012

Record last verified: 2012-03

Locations