- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07465081
Ultra-processed Food Consumption and Behavioral Disorder and Cognitive Function (UPF)
Relationship Between Ultra-processed Food Consumption and Behavioral Disorder and Cognitive Function in Children and Adolescents: the Mediation Role of Plasticizer
The goal of this interventional study is to determine whether reducing ultra-processed food consumption in children and adolescents can improve cognitive function. The main question it aims to answer is:
Does reducing ultra-processed food consumption through online nutritional education improve cognitive function in children and adolescents with attention difficulties? Researchers will compare a nutritional education group to a non-intervention group to assess whether reducing ultra-processed food intake leads to cognitive improvement.
Participants will:
Attend a weekly online nutritional education course for 12 weeks Be encouraged to replace ultra-processed foods with whole foods
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yi-Chen Huang, PhD
- Phone Number: 7523 +886422053366
- Email: yichenhuang@mail.cmu.edu.tw
Study Locations
-
-
-
Taichung, Taiwan, 406040
- Recruiting
- China Medical University Hospital
-
Contact:
- Yi-Chen Huang, PhD
- Phone Number: 7523 +88622053366
- Email: yichenhuang@mail.cmu.edu.tw
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 10-15 years old
- Diagnosed with attention deficit hyperactivity disorder (ADHD) or identified as having learning difficulties based on a specialist's or teacher's recommendation.
- >=six types or six servings of ultra-processed foods daily
Exclusion Criteria:
- Younger than 10 years old or older than 15 years old
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Nutritional education group
Online nutritional education
|
Attend a weekly online nutritional education course for 12 weeks
Other Names:
|
|
No Intervention: Control
Non nutritional education intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cognitive function
Time Frame: Baseline and after the intervention (at 12 weeks)
|
Cognitive function will be assessed using selected tasks from the Cambridge Neuropsychological Test Automated Battery (CANTAB), covering multiple cognitive domains.
CANTAB does not provide a single total score; each task generates task-specific outcome measures.
Higher accuracy scores and lower reaction times or error rates generally indicate better cognitive performance.
|
Baseline and after the intervention (at 12 weeks)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CMUH112-REC2-009
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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