EducationSMARTYNCT04175015
The SMARTY Trial: Evaluating the Effects of Colour of Candy on Perceptions of Taste
A study testing Smartie© sweet/candy in people with Education, run by National University of Ireland, Galway, Ireland at 1 site in Ireland.
Trial summary
The purpose of this trial is to determine if the colour of sweets (candy) effects taste. Read more about this study
- Who is it for?
- Ages 4 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Education
- What is being tested?
- Smartie© sweet/candy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIreland
- Study dates
- 24 Nov 2019to 24 Nov 2019
- 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 4 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- parental/guardian consent obtained
Who cannot join
- unable or unwilling to ingest intervention.
- medical conditions which prohibit ingestion of intervention (ie allergy, intolerance etc)
Trial locations and contacts
1 site in 1 country.
Ireland1 site
National University of Ireland Galway
Galway, Co. Galway, H91 TK33.
About this study
Official title: The SMARTY Trial: Evaluating the Effects of Colour of Candy on Perceptions of Taste. A Randomised Trial
The purpose of this trial is to determine if the colour of sweets (candy) effects taste.
Read the detailed description
The purpose of this trial is to increase children's awareness of randomised controlled trials and gain insights into the best way to conduct a fair comparison. Everyday children are faced with health claims, some reliable and some not so reliable. The purpose of the SMARTY trial is to help children critically assess and develop a critical eye when it comes to information they encounter every day, in particular when it comes to their health. The SMARTY trial is a pragmatic, two group, parallel, randomised trial.
- Conditions
- Education
- Being tested
- Smartie© sweet/candy
- Keywords
- Education, Randomised trial, Children, SMARTY
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartie© sweet/candyOther
one chocolate sweet/ chocolate candy
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Participants will be randomised to eat an orange coloured smartie© Receives: Other: Smartie© sweet/candy |
| Control Group | Active comparator | Participants will be randomised to eat a pink coloured smartie © Receives: Other: Smartie© sweet/candy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Taste
Participants will be asked to indicate on visual scale how much they like the taste of the smartie© they ate using the 'single-item sleep quality scale (SQS)' . The SQS is a self-administered visual analogue scale on which respondents rate the overall quality of sleep over a 7-day recall period on a likert type scaling option from 0 to 10, according to the following five categories: 0 = terrible, 1-3 = poor, 4-6 = fair, 7-9 = good, and 10 = excellent .
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start24 Nov 2019
- Primary completion24 Nov 2019
- Study completion24 Nov 2019
Why it stopped: It was not feasible to randomise participants due to the logistics of the science festival at which we were planning to run the trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EducationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Ireland, Galway, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Declan Devane, National University of Ireland, Galway, Ireland
- Investigators
- Declan Devane, PhD, Principal investigator, National University of Ireland, Galway, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04175015
- Sponsor's protocol ID
- NUIreland-SMARTY
- Acronym
- SMARTY
- Status last verified
- Oct 2024
- First submitted
- 19 Nov 2019
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SMARTY Trial: Evaluating the Effects of Colour of Candy on Perceptions of Taste. A Randomised Trial
- ClinicalTrials.gov ID
- NCT04175015
- Acronym / sponsor ID
- SMARTY / NUIreland-SMARTY
- Conditions
- Education
- Keywords
- Education, Randomised trial, Children, SMARTY
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: It was not feasible to randomise participants due to the logistics of the science festival at which we were planning to run the trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National University of Ireland, Galway, IrelandUniversity, hospital or other
- Study start
- 24 Nov 2019 (actual)
- Primary completion
- 24 Nov 2019 (actual)
- Study completion
- 24 Nov 2019 (actual)
- First posted
- 22 Nov 2019 (actual)
- 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 trial is to determine if the colour of sweets (candy) effects taste.
Detailed description
The purpose of this trial is to increase children's awareness of randomised controlled trials and gain insights into the best way to conduct a fair comparison. Everyday children are faced with health claims, some reliable and some not so reliable. The purpose of the SMARTY trial is to help children critically assess and develop a critical eye when it comes to information they encounter every day, in particular when it comes to their health. The SMARTY trial is a pragmatic, two group, parallel, randomised trial.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Smartie© sweet/candyParticipants will be randomised to eat an orange coloured smartie© |
| Control Group | Active comparator | Other: Smartie© sweet/candyParticipants will be randomised to eat a pink coloured smartie © |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- parental/guardian consent obtained
Key exclusion criteria (2 listed)
- unable or unwilling to ingest intervention.
- medical conditions which prohibit ingestion of intervention (ie allergy, intolerance etc)
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 |
|---|---|---|
| Smartie© sweet/candyone chocolate sweet/ chocolate candy | Other | Control Group, Experimental |
Primary outcome
Taste
Time frame: 15 minutes
Participants will be asked to indicate on visual scale how much they like the taste of the smartie© they ate using the 'single-item sleep quality scale (SQS)' . The SQS is a self-administered visual analogue scale on which respondents rate the overall quality of sleep over a 7-day recall period on a likert type scaling option from 0 to 10, according to the following five categories: 0 = terrible, 1-3 = poor, 4-6 = fair, 7-9 = good, and 10 = excellent .
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Declan Devane, PhD principal investigator
National University of Ireland, Galway, Ireland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartie© sweet/candy in people with Education, run by National University of Ireland, Galway, Ireland at 1 site in Ireland.
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 2 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: withdrawn, as of the sponsor's last update on 15 Oct 2024. 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 Ireland. 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 was withdrawn before enrolling participants, so there are no results.
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?
Taste (time frame: 15 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 15 Oct 2024.