ADD/ADHDUPFNCT07465081
Ultra-processed Food Consumption and Behavioral Disorder and Cognitive Function
A study testing Nutritional education group in people with ADD/ADHD, run by China Medical University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 15 years
- Conditions the study is for
- ADD/ADHD
- What is being tested?
- Nutritional education group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Mar 2025to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 10 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Younger than 10 years old or older than 15 years old
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung, 406040
Yi-Chen Huang, PhD, +88622053366 ext. 7523, yichenhuang@mail.cmu.edu.tw
About this study
Official title: 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
- Conditions
- ADD/ADHD
- Being tested
- Nutritional education group
- Keywords
- ultraprocessed food, ADD/ADHD, nutritional education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional education groupBehavioural
Also called NE
Attend a weekly online nutritional education course for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Nutritional education group | Experimental | Online nutritional education Receives: Behavioral: Nutritional education group |
| Control | No intervention | Non nutritional education intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function
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.
Measured: Baseline and after the intervention (at 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start5 Mar 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADD/ADHDStudies 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
- None (open label)
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07465081
- Sponsor's protocol ID
- CMUH112-REC2-009
- Acronym
- UPF
- Status last verified
- Aug 2026
- First submitted
- 6 Mar 2026
- Last updated
- 24 Aug 2026
- 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 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Ultra-processed Food Consumption and Behavioral Disorder and Cognitive Function in Children and Adolescents: the Mediation Role of Plasticizer
- ClinicalTrials.gov ID
- NCT07465081
- Acronym / sponsor ID
- UPF / CMUH112-REC2-009
- Conditions
- ADD/ADHD
- Keywords
- ultraprocessed food, ADD/ADHD, nutritional education
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 5 Mar 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 11 Mar 2026 (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 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutritional education group | Experimental | Behavioral: Nutritional education groupOnline nutritional education |
| Control | No intervention | –Non nutritional education intervention |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Younger than 10 years old or older than 15 years old
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 |
|---|---|---|
| Nutritional education groupAlso: NEAttend a weekly online nutritional education course for 12 weeks | Behavioural | Nutritional education group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional education group in people with ADD/ADHD, run by China Medical University Hospital at 1 site in Taiwan.
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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 24 Aug 2026. 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi-Chen Huang, PhD (+886422053366 ext. 7523, yichenhuang@mail.cmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function (time frame: Baseline and after the intervention (at 12 weeks)). 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 24 Aug 2026; AzTrials last refreshed its copy on 29 Oct 2026.