- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01427231
Short-term Effect of Glucose and Sacharose Ingestion on Cognitive Performance and Mood in Elderly
March 20, 2012 updated by: Lisette de Groot, Wageningen University
The Short-term Effect of Glucose and Sacharose Ingestion on Cognitive Performance and Mood in Elderly Subjects
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
43
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gelderland
-
Wageningen, Gelderland, Netherlands, 6703 HD
- Wageningen University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
70 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Drink with 50 g glucose
The glucose drink contains 50 g of glucose soluted in 250 ml of water and lemon juice.
|
The effect of a glucose solution on cognitive performance will be measured.
Other Names:
|
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.
|
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).
|
The effect of a placebo drink with sweeteners on cognitive performance will be measured.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Performance on the paired associate recall test
Time Frame: cognitive tests will start 15 minutes after ingestion of the intervention product
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
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)
|
Blood glucose response
Time Frame: from baseline till 90 minutes after consuming the drink
|
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
|
Plasma insulin levels
Time Frame: At t= -15 minutes, before consuming the test drink
|
One venapunction will be carried out at baseline to measure plasma insulin levels.
|
At t= -15 minutes, before consuming the test drink
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2011
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
August 26, 2011
First Submitted That Met QC Criteria
August 31, 2011
First Posted (Estimate)
September 1, 2011
Study Record Updates
Last Update Posted (Estimate)
March 21, 2012
Last Update Submitted That Met QC Criteria
March 20, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- NL36813.081.11
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mental Health
-
Chinese University of Hong KongNot yet recruitingMental Health Wellness 1 | Mental Well-being | Mental Health Issue | Precision Mental HealthHong Kong
-
King's College LondonCompletedMental Health Wellness 1 | Mental Health IssueUnited Kingdom
-
Chapin Hall at the University of ChicagoUniversity of ConnecticutCompletedMental Health | Physical Health
-
VA Office of Research and DevelopmentCompletedMental Health | Veterans Health | Rural HealthUnited States
-
National Taiwan Normal UniversityCompletedMental Health | Physical HealthTaiwan
-
Virginia Commonwealth UniversityCompletedMental Health DisordersUnited States
-
Johns Hopkins UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedMental Health DisordersCongo
-
Norwegian University of Science and TechnologySt. Olavs HospitalCompletedMental Health DisordersNorway
-
University of WarwickKing's College London; KU Leuven; University Hospital, Montpellier; Erasmus Medical... and other collaboratorsUnknownMental Health Disorder | Mental Health ImpairmentIreland, United Kingdom, Netherlands, Germany, Belgium, Croatia, France, Italy
-
York UniversityCanadian Institutes of Health Research (CIHR); North York General HospitalCompletedMental Health DisordersCanada
Clinical Trials on glucose
-
University of Texas Southwestern Medical CenterCompletedSarcoma | Neuroblastoma | Pediatric CancerUnited States
-
Children's Mercy Hospital Kansas CityWithdrawnType 1 DiabetesUnited States
-
University of Massachusetts, WorcesterNot yet recruitingPregnancy, High Risk | Type 2 Diabetes Treated With InsulinUnited States
-
Glostrup University Hospital, CopenhagenUnknown
-
Makassed General HospitalCompleted
-
US Department of Veterans AffairsEmory UniversityCompletedType 2 Diabetes Mellitus | Prediabetic StateUnited States
-
NestléCompletedHealthyNew Zealand
-
Unilever R&DLeiden University Medical CenterCompleted