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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04175015
Other study ID # NUIreland-SMARTY
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 24, 2019
Est. completion date April 1, 2020

Study information

Verified date January 2020
Source National University of Ireland, Galway, Ireland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this trial is to determine if the colour of sweets (candy) effects taste.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 150
Est. completion date April 1, 2020
Est. primary completion date November 24, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Smartie© sweet/candy
one chocolate sweet/ chocolate candy

Locations

Country Name City State
Ireland National University of Ireland Galway Galway Co. Galway

Sponsors (1)

Lead Sponsor Collaborator
National University of Ireland, Galway, Ireland

Country where clinical trial is conducted

Ireland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Taste Participants will be asked to indicate on visual scale how much they like the taste of the smartieĀ© 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
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