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

Mental Health Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01427231
• Other study ID #: NL36813.081.11
• Status: Completed
• Phase: N/A
• First received: August 26, 2011
• Last updated: March 20, 2012
• Start date: August 2011
• Est. completion date: December 2011

Study information

• Verified date: March 2012
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 70 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Attention
• Cognition
• Memory
• Mental Health

Intervention

Dietary Supplement:
• glucose
The effect of a glucose solution on cognitive performance will be measured.
• sacharose
The effect of a sacharose solution on cognitive performance will be measured.
• Placebo
The effect of a placebo drink with sweeteners on cognitive performance will be measured.

Locations

Country	Name	City	State
Netherlands	Wageningen University	Wageningen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Wageningen University	Suikerstichting Nederland (Baarn)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Mood	Mood will be measured by the POMS, after consuming the test drink, and after completing the congitive tests.	within 15 minutes after consuming the test drink and after completing the cognitive tests (within 90 minutes after consuming the test drink)	No
Secondary	Blood glucose response	Blood glucose will be measured at five time points, at t=0, after 15 minutes, 30, 60 and 90 minutes.	from baseline till 90 minutes after consuming the drink	No
Secondary	Plasma insulin levels	One venapunction will be carried out at baseline to measure plasma insulin levels.	At t= -15 minutes, before consuming the test drink	No