- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04175015
The SMARTY Trial: Evaluating the Effects of Colour of Candy on Perceptions of Taste (SMARTY)
January 30, 2020 updated by: Prof. Declan Devane, National University of Ireland, Galway, Ireland
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.
Study Overview
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 Type
Interventional
Enrollment (Anticipated)
150
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
-
-
Co. Galway
-
Galway, Co. Galway, Ireland, H91 TK33.
- National University of Ireland Galway
-
-
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
4 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- parental/guardian consent obtained
Exclusion Criteria:
- unable or unwilling to ingest intervention.
- medical conditions which prohibit ingestion of intervention (ie allergy, intolerance etc)
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
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental
Participants will be randomised to eat an orange coloured smartie©
|
one chocolate sweet/ chocolate candy
|
Active Comparator: Control Group
Participants will be randomised to eat a pink coloured smartie ©
|
one chocolate sweet/ chocolate candy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 .
|
15 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Actual)
November 24, 2019
Primary Completion (Actual)
November 24, 2019
Study Completion (Anticipated)
April 1, 2020
Study Registration Dates
First Submitted
November 19, 2019
First Submitted That Met QC Criteria
November 20, 2019
First Posted (Actual)
November 22, 2019
Study Record Updates
Last Update Posted (Actual)
February 5, 2020
Last Update Submitted That Met QC Criteria
January 30, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NUIreland-SMARTY
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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