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Could cutting Ultra-Processed foods reverse childhood metabolic syndrome?

NCT ID NCT05554016

Knowledge-focused Sponsor: Federico II University Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

Researchers are investigating whether eating ultra-processed foods is linked to obesity and metabolic syndrome in children and teens. The study will compare three groups: children with obesity, children with obesity plus metabolic syndrome, and healthy controls. Participants will record their food intake for a week, and researchers will measure certain compounds in the skin linked to these foods. The goal is to understand how these foods might contribute to metabolic problems in young people.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
No intervention; observational study of dietary intake of ultra-processed foods
What this could lead to
If a clear link emerges, it could guide dietary advice and public health policies to reduce ultra-processed food intake in children.
What could go wrong
This is an observational study, so it cannot prove cause and effect. The results may be influenced by other lifestyle factors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

200 people

The number who actually took part.

Started

Sep 2022

Finished

Feb 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Pediatric subjects of caucasian ethnicity, of both sexes, aged ≥6 and ≤18 years, with a sure diagnosis of obesity (Group 1), of obesity complicated by Metabolic Syndrome (Group 2), and age- and sex-matched healthy controls (Group 3).

Ages

6 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Caucasian ethnicity, both sexes, age ≥6 and ≤18 years, diagnosis of obesity (Group 1), diagnosis of obesity and Metabolic Syndrome (Group 2), and age- and sex-matched healthy controls (Group 3). Exclusion Criteria: * Non-Caucasian ethnicity; * Age \<6 or \>18 years; * Concomitant presence of chronic diseases, neoplasms, immunodeficiencies, chronic infections,autoimmune diseases, chronic inflammatory bowel disease, celiac disease, metabolic-genetic diseases, cystic fibrosis and other chronic lung diseases, cardiovascular/respiratory/gastrointestinal malformations, neuropsychiatric disorders, and neurological disorders; * Intake of antibiotics and/or pre/pro/synbiotics; * History of obesity surgery and onset of diarrhea or acute gastrointestinal illness during the 12 weeks prior to enrollment; * Presence of tattoos, scars, moles or special lesions on both forearms.

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Conditions

The condition(s) this trial relates to.

abdominal obesity-metabolic syndrome metabolic syndrome X morbid obesity obesity disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metabolic syndrome Obesity, morbid

Contacts and locations

Locations

  • Department of Traslational Medical Science - University of Naples Federico II

    Naples, Naples, 80131, Italy

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