Mental HealthNCT01427231
Short-term Effect of Glucose and Sacharose Ingestion on Cognitive Performance and Mood in Elderly
A study testing glucose and sacharose in people with Mental Health and Cognition, run by Wageningen University at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health, Cognition, Memory
- What is being tested?
- glucose and sacharose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2011to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Men and women
- 70 years and older
- Memory complaints
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Mental Health, Cognition, Memory, Attention
- Being tested
- glucose, sacharose, Placebo
- Keywords
- Cognitive performance, Attention, Memory, Glucose, Sacharose, Elderly, Memory complaints
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glucoseDietary supplement
Also called Sucrose, sugar.
The effect of a glucose solution on cognitive performance will be measured.
sacharoseDietary supplement
The effect of a sacharose solution on cognitive performance will be measured.
PlaceboDietary supplement
The effect of a placebo drink with sweeteners on cognitive performance will be measured.
| Study group | Role | What they receive |
|---|---|---|
| Drink with 50 g glucose | Active comparator | The glucose drink contains 50 g of glucose soluted in 250 ml of water and lemon juice. Receives: 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. Receives: 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). Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: cognitive tests will start 15 minutes after ingestion of the intervention product
Secondary outcomes (3)
Mood
Mood will be measured by the POMS, after consuming the test drink, and after completing the congitive tests.
Measured: 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
Blood glucose will be measured at five time points, at t=0, after 15 minutes, 30, 60 and 90 minutes.
Measured: from baseline till 90 minutes after consuming the drink
Plasma insulin levels
One venapunction will be carried out at baseline to measure plasma insulin levels.
Measured: At t= -15 minutes, before consuming the test drink
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- Suikerstichting Nederland (Baarn)
- Responsible party
- Principal investigator, Lisette de Groot, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01427231
- Sponsor's protocol ID
- NL36813.081.11
- Status last verified
- Mar 2012
- First submitted
- 26 Aug 2011
- Last updated
- 21 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Short-term Effect of Glucose and Sacharose Ingestion on Cognitive Performance and Mood in Elderly Subjects
- ClinicalTrials.gov ID
- NCT01427231
- Acronym / sponsor ID
- NL36813.081.11
- Conditions
- Mental Health, Cognition, Memory, Attention
- Keywords
- Cognitive performance, Attention, Memory, Glucose, Sacharose, Elderly, Memory complaints
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- Suikerstichting Nederland (Baarn)
- Study start
- Aug 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 1 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Drink with 50 g glucose | Active comparator | Dietary Supplement: glucoseThe glucose drink contains 50 g of glucose soluted in 250 ml of water and lemon juice. |
| Drink with 100 gram of sacharose | Active comparator | Dietary Supplement: sacharoseThe sacharose drink contains 100 g of sacharose soluted in 250 ml of water and lemon juice. |
| Placebo with sweeteners | Placebo comparator | Dietary Supplement: PlaceboThe 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). |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Men and women
- 70 years and older
- Memory complaints
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| glucoseAlso: Sucrose, sugar.The effect of a glucose solution on cognitive performance will be measured. | Dietary supplement | Drink with 50 g glucose |
| sacharoseThe effect of a sacharose solution on cognitive performance will be measured. | Dietary supplement | Drink with 100 gram of sacharose |
| PlaceboThe effect of a placebo drink with sweeteners on cognitive performance will be measured. | Dietary supplement | Placebo with sweeteners |
Primary outcome
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
3 secondary outcomes
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)
Blood glucose response
Time frame: from baseline till 90 minutes after consuming the drink
Plasma insulin levels
Time frame: At t= -15 minutes, before consuming the test drink
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing glucose and sacharose in people with Mental Health and Cognition, run by Wageningen University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance on the paired associate recall test (time frame: cognitive tests will start 15 minutes after ingestion of the intervention product). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2012.