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

Tracking Information
First Received Date ^ICMJE	August 26, 2011
Last Updated Date	March 20, 2012
Start Date ^ICMJE	August 2011
Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 31, 2011)	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
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01427231 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 31, 2011)	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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Short-term Effect of Glucose and Sacharose Ingestion on Cognitive Performance and Mood in Elderly
Official Title ^ICMJE	The Short-term Effect of Glucose and Sacharose Ingestion on Cognitive Performance and Mood in Elderly Subjects
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator)
Condition ^ICMJE	Mental Health Cognition Memory Attention
Intervention ^ICMJE	Dietary Supplement: glucose The effect of a glucose solution on cognitive performance will be measured. Other Name: Sucrose, sugar. Dietary Supplement: sacharose The effect of a sacharose solution on cognitive performance will be measured. Dietary Supplement: Placebo The effect of a placebo drink with sweeteners on cognitive performance will be measured.
Study Arm (s)	Active Comparator: Drink with 50 g glucose The glucose drink contains 50 g of glucose soluted in 250 ml of water and lemon juice. Intervention: Dietary Supplement: glucose 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. Intervention: Dietary Supplement: sacharose 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). Intervention: Dietary Supplement: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	43
Completion Date	December 2011
Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	70 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Netherlands

Administrative Information
NCT Number ^ICMJE	NCT01427231
Other Study ID Numbers ^ICMJE	NL36813.081.11
Has Data Monitoring Committee	Not Provided
Responsible Party	Lisette de Groot, Wageningen University
Study Sponsor ^ICMJE	Wageningen University
Collaborators ^ICMJE	Suikerstichting Nederland (Baarn)
Investigators ^ICMJE	Not Provided
Information Provided By	Wageningen University
Verification Date	March 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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