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Short-term Effect of Glucose and Sacharose Ingestion on Cognitive Performance and Mood in Elderly

This study has been completed.
Sponsor:
Collaborator:
Suikerstichting Nederland (Baarn)
Information provided by (Responsible Party):
Lisette de Groot, Wageningen University
ClinicalTrials.gov Identifier:
NCT01427231
First received: August 26, 2011
Last updated: March 20, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention
Mental Health
Cognition
Memory
Attention
 Dietary Supplement: glucose
Dietary Supplement: sacharose
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: The Short-term Effect of Glucose and Sacharose Ingestion on Cognitive Performance and Mood in Elderly Subjects

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by Wageningen University:

Primary Outcome Measures:
  • Performance on the paired associate recall test [ Time Frame: cognitive tests will start 15 minutes after ingestion of the intervention product ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Mood [ Time Frame: within 15 minutes after consuming the test drink and after completing the cognitive tests (within 90 minutes after consuming the test drink) ] [ Designated as safety issue: No ]
    Mood will be measured by the POMS, after consuming the test drink, and after completing the congitive tests.

  • Blood glucose response [ Time Frame: from baseline till 90 minutes after consuming the drink ] [ Designated as safety issue: No ]
    Blood glucose will be measured at five time points, at t=0, after 15 minutes, 30, 60 and 90 minutes.

  • Plasma insulin levels [ Time Frame: At t= -15 minutes, before consuming the test drink ] [ Designated as safety issue: No ]
    One venapunction will be carried out at baseline to measure plasma insulin levels.


Enrollment: 43
Study Start Date: August 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Drink with 50 g glucose
The glucose drink contains 50 g of glucose soluted in 250 ml of water and lemon juice.
 Dietary Supplement: glucose
The effect of a glucose solution on cognitive performance will be measured.
Other Name: Sucrose, sugar.
Active Comparator: Drink with 100 gram of sacharose
The sacharose drink contains 100 g of sacharose soluted in 250 ml of water and lemon juice.
 Dietary Supplement: sacharose
The effect of a sacharose solution on cognitive performance will be measured.
Placebo Comparator: Placebo with sweeteners
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
The effect of a placebo drink with sweeteners on cognitive performance will be measured.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and women
  • 70 years and older
  • Memory complaints

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01427231

Locations
Netherlands
Wageningen University
Wageningen, Gelderland, Netherlands, 6703 HD
Sponsors and Collaborators
Wageningen University
Suikerstichting Nederland (Baarn)
  More Information

No publications provided

Responsible Party: Lisette de Groot, PhD, Wageningen University
ClinicalTrials.gov Identifier: NCT01427231     History of Changes
Other Study ID Numbers: NL36813.081.11
Study First Received: August 26, 2011
Last Updated: March 20, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Wageningen University:
Cognitive performance
Attention
Memory
Glucose
 Sacharose
Elderly
Memory complaints

ClinicalTrials.gov processed this record on May 19, 2013