DementiaNCT01842022
The Effect of the Glycemic Load of Meals on the Cognition and Mood of Older Adults
A study testing Isomaltulose, Sucrose and Glucose in people with Dementia, run by Swansea University at 1 site in United Kingdom.
Trial summary
A lower rather than a higher glycemic load (GL) meal has been shown to benefit cognition and mood, however, the data in older adults and those most prone to cognitive dysfunction, is limited and conflicting. One explanation is that the GL of a meal may interact with a person's pre-existing glucose tolerance (GT). Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia
- What is being tested?
- Isomaltulose, Sucrose and Glucose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2011to Sep 2013
- 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 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults of 45 to 80 years
Who cannot join
- Type 1 or type 2 diabetes
- Dementia
- Liver disease
- Gastro-intestinal problems
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Psychology, Swansea University
Swansea, Wales, sa2 8pp
About this study
Official title: The Effect of the Glycemic Load of Meals on the Cognition and Mood of Older Adults With Differences in Glucose Tolerance
A lower rather than a higher glycemic load (GL) meal has been shown to benefit cognition and mood, however, the data in older adults and those most prone to cognitive dysfunction, is limited and conflicting. One explanation is that the GL of a meal may interact with a person's pre-existing glucose tolerance (GT).
As older adults have a higher incidence of glucose tolerance and are more likely to experience memory problems the present study considers the interaction between the GL of meal in those with better or poorer GT.
The population studied will not have a history of diabetes or dementia. A battery of cognitive tests will be administered after meals sweetened with one of three sugars known to vary in the rate that they release glucose into the blood stream.
Read the detailed description
On day one subjects will take an oral glucose tolerance test and will then be divided into four groups depending on their glucose tolerance (how long values remain raised) and the tendency for values to subsequently fall to low values.
On a second occasion 155 healthy older adults, aged 45-80 years, will be randomly assigned to receive either a glucose, sucrose or isomaltulose based meal. All meals are matched on macronutrient composition and differ only in glycemic load. Cognitive performance and mood will be assessed 30, 105 and 180 minutes after breakfast. Measures of memory, attention, reaction times and mood will be taken.
The response to the three meals will be contrasted in those with different glucose profiles on day one
- Conditions
- Dementia
- Being tested
- Isomaltulose, Sucrose, Glucose
- Keywords
- Glycemic load, memory, mood
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsomaltuloseDietary supplement
Isomaltulose sweetened meal will be given to each of four groups who differ in their glucose tolerance
SucroseDietary supplement
Sucrose sweetened meal will be given to each of four groups who differ in their glucose tolerance
GlucoseDietary supplement
Glucose sweetened meal will be given to each of four groups who differ in their glucose tolerance
| Study group | Role | What they receive |
|---|---|---|
| Better glucose tolerance | Other | Take meals with isomaltulose, sucrose or glucose Receives: Dietary Supplement: Isomaltulose; Dietary Supplement: Sucrose; Dietary Supplement: Glucose |
| Better glucose tolerance / Levels fall | Other | Take meals with isomaltulose, sucrose or glucose Receives: Dietary Supplement: Isomaltulose; Dietary Supplement: Sucrose; Dietary Supplement: Glucose |
| Poorer tolerance levels remain high | Other | Take meals with isomaltulose, sucrose or glucose Receives: Dietary Supplement: Isomaltulose; Dietary Supplement: Sucrose; Dietary Supplement: Glucose |
| Poorer glucose tolerance / Levels fall | Other | Take meals with isomaltulose, sucrose or glucose Receives: Dietary Supplement: Isomaltulose; Dietary Supplement: Sucrose; Dietary Supplement: Glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in episodic memory
Episodic memory assessed by asking subjects to recall a list of words
Measured: 30, 105, 180 minutes
Secondary outcomes (1)
Change in mood
Visual analogues scales used to report mood at six points during study
Measured: 30, 105, 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2013 (estimated)
- Study startSep 2011
- Primary completionMay 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swansea University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Benton, Swansea University
- Investigators
- David Benton, DSc, Principal investigator, Swansea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01842022
- Sponsor's protocol ID
- DB-0413
- Status last verified
- Dec 2014
- First submitted
- 9 Apr 2013
- Last updated
- 11 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Glycemic Load of Meals on the Cognition and Mood of Older Adults With Differences in Glucose Tolerance
- ClinicalTrials.gov ID
- NCT01842022
- Acronym / sponsor ID
- DB-0413
- Conditions
- Dementia
- Keywords
- Glycemic load, memory, mood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Swansea UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- May 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 29 Apr 2013 (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.
A lower rather than a higher glycemic load (GL) meal has been shown to benefit cognition and mood, however, the data in older adults and those most prone to cognitive dysfunction, is limited and conflicting. One explanation is that the GL of a meal may interact with a person's pre-existing glucose tolerance (GT).
As older adults have a higher incidence of glucose tolerance and are more likely to experience memory problems the present study considers the interaction between the GL of meal in those with better or poorer GT.
The population studied will not have a history of diabetes or dementia. A battery of cognitive tests will be administered after meals sweetened with one of three sugars known to vary in the rate that they release glucose into the blood stream.
Detailed description
On day one subjects will take an oral glucose tolerance test and will then be divided into four groups depending on their glucose tolerance (how long values remain raised) and the tendency for values to subsequently fall to low values.
On a second occasion 155 healthy older adults, aged 45-80 years, will be randomly assigned to receive either a glucose, sucrose or isomaltulose based meal. All meals are matched on macronutrient composition and differ only in glycemic load. Cognitive performance and mood will be assessed 30, 105 and 180 minutes after breakfast. Measures of memory, attention, reaction times and mood will be taken.
The response to the three meals will be contrasted in those with different glucose profiles on day one
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Better glucose tolerance | Other | Dietary Supplement: Isomaltulose, Dietary Supplement: Sucrose, Dietary Supplement: GlucoseTake meals with isomaltulose, sucrose or glucose |
| Better glucose tolerance / Levels fall | Other | Dietary Supplement: Isomaltulose, Dietary Supplement: Sucrose, Dietary Supplement: GlucoseTake meals with isomaltulose, sucrose or glucose |
| Poorer tolerance levels remain high | Other | Dietary Supplement: Isomaltulose, Dietary Supplement: Sucrose, Dietary Supplement: GlucoseTake meals with isomaltulose, sucrose or glucose |
| Poorer glucose tolerance / Levels fall | Other | Dietary Supplement: Isomaltulose, Dietary Supplement: Sucrose, Dietary Supplement: GlucoseTake meals with isomaltulose, sucrose or glucose |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adults of 45 to 80 years
Key exclusion criteria (4 listed)
- Type 1 or type 2 diabetes
- Dementia
- Liver disease
- Gastro-intestinal problems
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 |
|---|---|---|
| IsomaltuloseIsomaltulose sweetened meal will be given to each of four groups who differ in their glucose tolerance | Dietary supplement | Better glucose tolerance, Better glucose tolerance / Levels fall, Poorer glucose tolerance / Levels fall, Poorer tolerance levels remain high |
| SucroseSucrose sweetened meal will be given to each of four groups who differ in their glucose tolerance | Dietary supplement | Better glucose tolerance, Better glucose tolerance / Levels fall, Poorer glucose tolerance / Levels fall, Poorer tolerance levels remain high |
| GlucoseGlucose sweetened meal will be given to each of four groups who differ in their glucose tolerance | Dietary supplement | Better glucose tolerance, Better glucose tolerance / Levels fall, Poorer glucose tolerance / Levels fall, Poorer tolerance levels remain high |
Primary outcome
Change in episodic memory
Time frame: 30, 105, 180 minutes
Episodic memory assessed by asking subjects to recall a list of words
1 secondary outcome
Change in mood
Time frame: 30, 105, 180 minutes
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 11 Dec 2014.
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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.
David Benton, DSc principal investigator
Swansea University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isomaltulose, Sucrose and Glucose in people with Dementia, run by Swansea University at 1 site in United Kingdom.
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 1 inclusion and 4 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 11 Dec 2014. 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 United Kingdom. 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. 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?
Change in episodic memory (time frame: 30, 105, 180 minutes). 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 11 Dec 2014.