Obesity, MorbidUFO ProjectNCT05554016
The UFO (Ultra Processed Foods in Obesity) Project
An observational study of Obesity, Morbid and Metabolic Syndrome, run by Federico II University at 1 site in Italy.
Trial summary
The childhood obesity prevalence has increased dramatically in the last decades, affecting more than 340 million children worldwide. This condition is the major risk factor for a set of metabolic abnormalities, also known as metabolic syndrome, a condition that reduce life expectancy by 5-20 years. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Obesity, Morbid, Metabolic Syndrome
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2022to 1 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 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).
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Traslational Medical Science - University of Naples Federico II
Naples, Naples, 80131
About this study
The childhood obesity prevalence has increased dramatically in the last decades, affecting more than 340 million children worldwide. This condition is the major risk factor for a set of metabolic abnormalities, also known as metabolic syndrome, a condition that reduce life expectancy by 5-20 years. Changes in the global food system, and the increased consumption of ultra-processed foods (UPFs), may have contributed to the increase in the prevalence of childhood obesity and related morbidities. The mechanisms by which UPFs might promote obesity and metabolic syndrome could be multiple and not completely identified.
The Ultra-processed Food in Obesity (UFO) Project has been designed to investigate the potential associations between UPFs intake and MetS in pediatric subjects
- Conditions
- Obesity, Morbid, Metabolic Syndrome
- Medical subject headings
- Obesity, Morbid, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Pediatric patients with obesity | |
| Group 2 | Pediatric patients with obesity complicated by Metabolic Syndrome | |
| Group 3 | Age- and sex-matched healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary UPF intake
The assessment of dietary UPF intake will be carried out through a 7-day food diary.
Measured: At enrollment
Secondary outcomes (11)
Daily intake of energy and nutrients
The daily intake of energy (kcal) and nutrients will be carried out through a 7-day food diary.
Measured: At enrollment
Daily dietary intake of AGEs
The intake of Advanced Glycation Endproducts (mostly present in UPFs).
Measured: At enrollment
Skin AGEs levels
The skin accumulation of AGEs in the subcutaneous.
Measured: At enrollment
RAGE expression in peripheral blood mononuclear cells
The expressione of the AGEs receptor in peripheral blood mononuclear cells.
Measured: At enrollment
Soluble form of RAGE expression
The expressione of the AGEs receptor in the serum.
Measured: At enrollment
Mitochondrial metabolism
The mitochondrial metabolism through the Seahorse XFp analyzer.
Measured: At enrollment
Oxidative stress
Oxidative stress biomarkers.
Measured: At enrollment
Interleukin-6
Serum levels of Interleukin-6.
Measured: At enrollment
MicroRNA-221 expression
MicroRNA-221 expression in peripheral blood mononuclear cells.
Measured: At enrollment
Leptin
Serum levels of leptin.
Measured: At enrollment
Ghrelin
Serum levels of ghrelin.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start1 Sep 2022
- Primary completion1 Sep 2025
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Berni Canani, MD, PhD, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05554016
- Sponsor's protocol ID
- 00019173
- Acronym
- UFO Project
- Status last verified
- Jun 2026
- First submitted
- 21 Sep 2022
- Last updated
- 2 Sep 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 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The UFO (Ultra Processed Foods in Obesity) Project
- ClinicalTrials.gov ID
- NCT05554016
- Acronym / sponsor ID
- UFO Project / 00019173
- Conditions
- Obesity, Morbid, Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 26 Sep 2022 (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 childhood obesity prevalence has increased dramatically in the last decades, affecting more than 340 million children worldwide. This condition is the major risk factor for a set of metabolic abnormalities, also known as metabolic syndrome, a condition that reduce life expectancy by 5-20 years. Changes in the global food system, and the increased consumption of ultra-processed foods (UPFs), may have contributed to the increase in the prevalence of childhood obesity and related morbidities. The mechanisms by which UPFs might promote obesity and metabolic syndrome could be multiple and not completely identified.
The Ultra-processed Food in Obesity (UFO) Project has been designed to investigate the potential associations between UPFs intake and MetS in pediatric subjects
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Pediatric patients with obesity |
| Group 2 | – | –Pediatric patients with obesity complicated by Metabolic Syndrome |
| Group 3 | – | –Age- and sex-matched healthy controls |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 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).
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dietary UPF intake
Time frame: At enrollment
The assessment of dietary UPF intake will be carried out through a 7-day food diary.
11 secondary outcomes
Daily intake of energy and nutrients
Time frame: At enrollment
Daily dietary intake of AGEs
Time frame: At enrollment
Skin AGEs levels
Time frame: At enrollment
RAGE expression in peripheral blood mononuclear cells
Time frame: At enrollment
Soluble form of RAGE expression
Time frame: At enrollment
Mitochondrial metabolism
Time frame: At enrollment
Oxidative stress
Time frame: At enrollment
Interleukin-6
Time frame: At enrollment
MicroRNA-221 expression
Time frame: At enrollment
Leptin
Time frame: At enrollment
Ghrelin
Time frame: At enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Morbid and Metabolic Syndrome, run by Federico II University at 1 site in Italy.
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 2 Sep 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dietary UPF intake (time frame: At enrollment). 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 2 Sep 2026.