NCT07465081

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2025

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 6, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 11, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Completed
Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

1.4 years

First QC Date

March 6, 2026

Last Update Submit

March 6, 2026

Conditions

ADD/ADHD

Keywords

ultraprocessed foodADD/ADHDnutritional education

Outcome Measures

Primary Outcomes (1)

  • Cognitive function

    Cognitive function is evaluated by Cambridge Neuropsychological Test Automated Battery (CANTAB)

    Baseline and after the intervention (at 12 weeks)

Study Arms (2)

Nutritional education group

EXPERIMENTAL

Online nutritional education

Behavioral: Nutritional education group

Control

NO INTERVENTION

Non nutritional education intervention

Interventions

Nutritional education groupBEHAVIORAL

Attend a weekly online nutritional education course for 12 weeks

Also known as: NE
Nutritional education group

Eligibility Criteria

Age10 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Participants must meet all of the following conditions:
  • Age: 10-15 years old. Attention difficulties: Diagnosed with attention deficit hyperactivity disorder (ADHD) or identified as having learning difficulties based on a specialist's or teacher's recommendation.
  • Ultra-processed food consumption: Consumes at least six types or six servings of ultra-processed foods daily.

You may not qualify if:

  • Younger than 10 years old or older than 15 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, 406040, Taiwan

RECRUITING

Central Study Contacts

Yi-Chen Huang, PhD

CONTACT

+886422053366yichenhuang@mail.cmu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2026

First Posted

March 11, 2026

Study Start

March 5, 2025

Primary Completion

July 31, 2026

Study Completion

July 31, 2026

Last Updated

March 11, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)