MalnutritionNCT06152848
The SAM Project: Science Against Malnutrition Project
An observational study of Malnutrition, run by Federico II University at 1 site in Italy.
Trial summary
The latest data from the World Health Organization (WHO) shows that malnutrition in all its forms affects over 2.5 billion people globally. This condition is constantly increasing and affects the entire population, from childhood to the elderly. Read more about this study
- Who is it for?
- Ages 0 to 85 years
- Conditions the study is for
- Malnutrition
- What is being tested?
- Data and samples collection
- How many people
- 2,000 participants
- Where
- 1 siteItaly
- Study dates
- 24 Jul 2023to 24 Jul 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 0 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 1000 patients affected by malnutrition due to deficiency or excess, associated with at least one of the pathological conditions(small for gestational age; metabolic syndrome; type 1 diabetes mellitus; neurological diseases; psychiatric; chronic infectious diseases; oncological pathologies; gastrointestinal diseases; cardiovascular diseases; kidney disease; lung pathologies) aged 0-85 years (50% male) and 1000 sex- and age- matched healthy controls not affected by any pathology and/or malnutrition due to deficiency or excess.
Who may be able to join
- Caucasian ethnicity;
- both sexes;
- age between 0 and 85 years;
- affected by malnutrition due to deficiency or excess in association with other patology and sex- and age-matched healthy controls not affected by malnutrition due to deficiency or excess and any pathology
- Written informed consent
Who cannot join
- Non-Caucasian ethnicity;
- Age > 85 years.
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 latest data from the World Health Organization (WHO) shows that malnutrition in all its forms affects over 2.5 billion people globally. This condition is constantly increasing and affects the entire population, from childhood to the elderly. Malnutrition in all its forms negatively impacts the quality of life of patients affected and increases the risk of morbidity and mortality, as well as healthcare costs. Considering the complexity and multifactorial nature of malnutrition, the integration of multi-omics data obtained from analyzes with high-throughput technologies such as epigenomics, metagenomics, metabolomics, could benefit the prediction and evaluation of prognosis and/or response to specific treatments; this could pave the way for personalized precision medicine interventions for patients suffering from malnutrition. The SAM study aims to characterize malnutrition through the identification of specific biomarkers of the condition with the aim of developing innovative prevention and treatment programs.
- Conditions
- Malnutrition
- Being tested
- Data and samples collection
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data and samples collectionOther
Collection of clinical, anamnestic and lifestyle data; collection of faecal, blood and saliva samples
| Study group | Role | What they receive |
|---|---|---|
| Patients affected by malnutrition | Patients affected by malnutrition due to deficiency or excess Receives: Other: Data and samples collection | |
| Sex- and age- matched healthy controls | Sex- and age- matched healthy controls not affected by any pathology and/or malnutrition due to deficiency or excess Receives: Other: Data and samples collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of malnutrition through the identification of specific biomarkers of the condition.
Data and samples analyses
Measured: 36 months
Untargeted microRNA expression profile in blood samples
TruSeq Small RNA Sample Preparation Kit (Illumina)
Measured: 36 months
Plasmatic extracellular vesicles
A transmission electron microscope will be used to analyze the morphology of extracellular vesicles and the total protein concentration of the extracellular vesicles will be measured with a Bradford assay and the quantitation of specific membrane proteins and specific intracellular proteins (Heat-Shock Proteins/HSP) will be carried out by ELISA.
Measured: 36 months
Metagenomic analysis of fecal samples
Shotgun analysis
Measured: 36 months
Metabolomicanalysis of fecal samples
Gas chromatography-mass spectrometry
Measured: 36 months
Untargeted microRNA expression profile in saliva samples
TruSeq Small RNA Sample Preparation Kit (Illumina)
Measured: 36 months
Salivary extracellular vesicles
A transmission electron microscope will be used to analyze the morphology of extracellular vesicles and the total protein concentration of the extracellular vesicles will be measured with a Bradford assay and the quantitation of specific membrane proteins and specific intracellular proteins (Heat-Shock Proteins/HSP) will be carried out by ELISA.
Measured: 36 months
Metagenomic analysis of salivary samples
Shotgun analysis
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start24 Jul 2023
- Primary completion24 Jul 2026
- Study completion24 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies 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
- 2,000 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
- NCT06152848
- Sponsor's protocol ID
- 2/2023
- Status last verified
- Aug 2026
- First submitted
- 22 Nov 2023
- Last updated
- 1 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SAM Project: Science Against Malnutrition Project
- ClinicalTrials.gov ID
- NCT06152848
- Acronym / sponsor ID
- 2/2023
- Conditions
- Malnutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 24 Jul 2023 (actual)
- Primary completion
- 24 Jul 2026 (actual)
- Study completion
- 24 Jul 2026 (actual)
- First posted
- 1 Dec 2023 (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 latest data from the World Health Organization (WHO) shows that malnutrition in all its forms affects over 2.5 billion people globally. This condition is constantly increasing and affects the entire population, from childhood to the elderly. Malnutrition in all its forms negatively impacts the quality of life of patients affected and increases the risk of morbidity and mortality, as well as healthcare costs. Considering the complexity and multifactorial nature of malnutrition, the integration of multi-omics data obtained from analyzes with high-throughput technologies such as epigenomics, metagenomics, metabolomics, could benefit the prediction and evaluation of prognosis and/or response to specific treatments; this could pave the way for personalized precision medicine interventions for patients suffering from malnutrition. The SAM study aims to characterize malnutrition through the identification of specific biomarkers of the condition with the aim of developing innovative prevention and treatment programs.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients affected by malnutrition | – | Other: Data and samples collectionPatients affected by malnutrition due to deficiency or excess |
| Sex- and age- matched healthy controls | – | Other: Data and samples collectionSex- and age- matched healthy controls not affected by any pathology and/or malnutrition due to deficiency or excess |
Who may qualify
- Ages
- 0 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 1000 patients affected by malnutrition due to deficiency or excess, associated with at least one of the pathological conditions(small for gestational age; metabolic syndrome; type 1 diabetes mellitus; neurological diseases; psychiatric; chronic infectious diseases; oncological pathologies; gastrointestinal diseases; cardiovascular diseases; kidney disease; lung pathologies) aged 0-85 years (50% male) and 1000 sex- and age- matched healthy controls not affected by any pathology and/or malnutrition due to deficiency or excess.
Key inclusion criteria (5 listed)
- Caucasian ethnicity;
- both sexes;
- age between 0 and 85 years;
- affected by malnutrition due to deficiency or excess in association with other patology and sex- and age-matched healthy controls not affected by malnutrition due to deficiency or excess and any pathology
- Written informed consent
Key exclusion criteria (2 listed)
- Non-Caucasian ethnicity;
- Age > 85 years.
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 |
|---|---|---|
| Data and samples collectionCollection of clinical, anamnestic and lifestyle data; collection of faecal, blood and saliva samples | Other | Patients affected by malnutrition, Sex- and age- matched healthy controls |
Primary outcome
Characterization of malnutrition through the identification of specific biomarkers of the condition.
Time frame: 36 months
Data and samples analyses
Untargeted microRNA expression profile in blood samples
Time frame: 36 months
TruSeq Small RNA Sample Preparation Kit (Illumina)
Plasmatic extracellular vesicles
Time frame: 36 months
A transmission electron microscope will be used to analyze the morphology of extracellular vesicles and the total protein concentration of the extracellular vesicles will be measured with a Bradford assay and the quantitation of specific membrane proteins and specific intracellular proteins (Heat-Shock Proteins/HSP) will be carried out by ELISA.
Metagenomic analysis of fecal samples
Time frame: 36 months
Shotgun analysis
Metabolomicanalysis of fecal samples
Time frame: 36 months
Gas chromatography-mass spectrometry
Untargeted microRNA expression profile in saliva samples
Time frame: 36 months
TruSeq Small RNA Sample Preparation Kit (Illumina)
Salivary extracellular vesicles
Time frame: 36 months
A transmission electron microscope will be used to analyze the morphology of extracellular vesicles and the total protein concentration of the extracellular vesicles will be measured with a Bradford assay and the quantitation of specific membrane proteins and specific intracellular proteins (Heat-Shock Proteins/HSP) will be carried out by ELISA.
Metagenomic analysis of salivary samples
Time frame: 36 months
Shotgun analysis
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 1 Sep 2026.
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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 Malnutrition, 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 5 inclusion and 2 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 1 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?
Characterization of malnutrition through the identification of specific biomarkers of the condition. (time frame: 36 months). The study lists 8 primary outcomes in all. 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 1 Sep 2026.