Self-controlNCT02075333
The Effect of Ingesting or Rinsing Sucrose and Sucralose on Self-control, Cognitive Performance, and Blood Glucose
A study testing Ingestion of solution and Rinising of solution in people with Self-control and Cognitive Performance, run by University of Leeds at 1 site in United Kingdom.
Trial summary
The purpose of this study is to examine the effects of ingesting or mouth rinsing a sucrose (carbohydrate) versus a sucralose (carbohydrate-free) drink on self control, cognitive performance, and blood glucose level. Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Self-control, Cognitive Performance, Blood Glucose Response
- What is being tested?
- Ingestion of solution and Rinising of solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2014to Aug 2014
- 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 50 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI 18 - 29 kg/m2
Who cannot join
- Dementia
- Depression
- Type 2 diabetes
- Phenylketonuria
- Intake of medication known to affect glucose metabolism
- Fasting blood glucose > 7.8 mmol/L
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Human Appetite Research Unit (University of Leeds)
Leeds, LS29JT
About this study
Official title: The Effects of Ingesting or Rinsing Sucrose and Sucralose Solutions on Self-control, Cognitive Performance, and Blood Glucose Level
The purpose of this study is to examine the effects of ingesting or mouth rinsing a sucrose (carbohydrate) versus a sucralose (carbohydrate-free) drink on self control, cognitive performance, and blood glucose level.
- Conditions
- Self-control, Cognitive Performance, Blood Glucose Response
- Being tested
- Ingestion of solution, Rinising of solution
- Medical subject headings
- Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ingestion of solutionDietary supplement
Participants will ingest the solution
Rinising of solutionDietary supplement
Participants rinse the solution in the oral cavity
| Study group | Role | What they receive |
|---|---|---|
| Sucrose (50g) | Active comparator | A 381g blackcurrant drink (cordial and water) providing 50g of sucrose Receives: Dietary Supplement: Ingestion of solution; Dietary Supplement: Rinising of solution |
| Sucralose (0.92 g sugars) | Placebo comparator | A 381g blackcurrant drink (cordial and water) providing 0.92g of natural sugars Receives: Dietary Supplement: Ingestion of solution; Dietary Supplement: Rinising of solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Capillary blood glucose change from baseline following rinsing or ingesting sucrose or sucralose solutions
Change from baseline in capillary blood glucose (assessed by lancet fingerprick and YSI blood glucose analyser)
Measured: - 30, -15, - 5, + 5, + 10, + 20, + 30, + 40 minutes relative to rinsing or ingestion of sucrose or sucralose solutions (each separated by 7 days in crossover manner)
Secondary outcomes (3)
Visual verbal learning and memory performance following self-control depletion
Visual verbal learning performance will be assessed by the Visual Verbal Learning Test (Rey, 1964) following a self-control depletion task and ingestion or rinsing of a sucrose or sucralose solution
Measured: + 35 minutes post ingestion or rinsing of sucrose or sucralose solutions (each separated by 7 days in crossover manner)
Attention switching performance following self-control depletion
Attention switching performance will be assessed by a switch task (Rogers and Monsell, 1995) following a self-control depletion task and ingestion or rinsing of a sucrose or sucralose solution
Measured: + 20 minutes post ingestion or rinsing of sucrose or sucralose solutions (each separated by 7 days in crossover manner)
Continuous blood glucose change from baseline following rinsing or ingesting sucrose or sucralose solutions
A subgroup of 10 participants recruited into the study will be fitted with a continuous glucose monitoring device (CGMS, iPRO) the day preceding each of the test days to measure continuous interstitial blood glucose levels
Measured: 24 hours preceding and during ingestion or rinsing of sucrose or sucralose solutions (each separated by 7 days in a crossover manner)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study startJan 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self-controlStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- Sugar Nutrition, UK
- Responsible party
- Principal investigator, Prof Louise Dye, University of Leeds
- Investigators
- Neil B Boyle, Principal investigator, University of LeedsLouise Dye, Study chair, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02075333
- Sponsor's protocol ID
- SN - 0114
- Status last verified
- May 2016
- First submitted
- 26 Feb 2014
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Ingesting or Rinsing Sucrose and Sucralose Solutions on Self-control, Cognitive Performance, and Blood Glucose Level
- ClinicalTrials.gov ID
- NCT02075333
- Acronym / sponsor ID
- SN - 0114
- Conditions
- Self-control, Cognitive Performance, Blood Glucose Response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- Sugar Nutrition, UK
- Study start
- Jan 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 3 Mar 2014 (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 purpose of this study is to examine the effects of ingesting or mouth rinsing a sucrose (carbohydrate) versus a sucralose (carbohydrate-free) drink on self control, cognitive performance, and blood glucose level.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sucrose (50g) | Active comparator | Dietary Supplement: Ingestion of solution, Dietary Supplement: Rinising of solutionA 381g blackcurrant drink (cordial and water) providing 50g of sucrose |
| Sucralose (0.92 g sugars) | Placebo comparator | Dietary Supplement: Ingestion of solution, Dietary Supplement: Rinising of solutionA 381g blackcurrant drink (cordial and water) providing 0.92g of natural sugars |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI 18 - 29 kg/m2
Key exclusion criteria (6 listed)
- Dementia
- Depression
- Type 2 diabetes
- Phenylketonuria
- Intake of medication known to affect glucose metabolism
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 |
|---|---|---|
| Ingestion of solutionParticipants will ingest the solution | Dietary supplement | Sucralose (0.92 g sugars), Sucrose (50g) |
| Rinising of solutionParticipants rinse the solution in the oral cavity | Dietary supplement | Sucralose (0.92 g sugars), Sucrose (50g) |
Primary outcome
Capillary blood glucose change from baseline following rinsing or ingesting sucrose or sucralose solutions
Time frame: - 30, -15, - 5, + 5, + 10, + 20, + 30, + 40 minutes relative to rinsing or ingestion of sucrose or sucralose solutions (each separated by 7 days in crossover manner)
Change from baseline in capillary blood glucose (assessed by lancet fingerprick and YSI blood glucose analyser)
3 secondary outcomes
Visual verbal learning and memory performance following self-control depletion
Time frame: + 35 minutes post ingestion or rinsing of sucrose or sucralose solutions (each separated by 7 days in crossover manner)
Attention switching performance following self-control depletion
Time frame: + 20 minutes post ingestion or rinsing of sucrose or sucralose solutions (each separated by 7 days in crossover manner)
Continuous blood glucose change from baseline following rinsing or ingesting sucrose or sucralose solutions
Time frame: 24 hours preceding and during ingestion or rinsing of sucrose or sucralose solutions (each separated by 7 days in a crossover manner)
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 12 May 2016.
- Individual participant dataSharing planned: Undecided
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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.
Neil B Boyle principal investigator
University of Leeds
Louise Dye study chair
University of Leeds
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ingestion of solution and Rinising of solution in people with Self-control and Cognitive Performance, run by University of Leeds 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 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 12 May 2016. 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. 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?
Capillary blood glucose change from baseline following rinsing or ingesting sucrose or sucralose solutions (time frame: - 30, -15, - 5, + 5, + 10, + 20, + 30, + 40 minutes relative to rinsing or ingestion of sucrose or sucralose solutions (each separated by 7 days in crossover manner)). 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 12 May 2016.