The SAM Project: Science Against Malnutrition Project

June 3, 2025 updated by: Roberto Berni Canani, MD, PhD, Federico II University
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Naples, Italy, 80131
        • Recruiting
        • Department of Traslational Medical Science - University of Naples Federico II
        • Contact:
          • Roberto Berni Canani, MD, PhD
          • Phone Number: 0817462680
          • Email: berni@unina.it

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Non-Caucasian ethnicity;
  • Age > 85 years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients affected by malnutrition
Patients affected by malnutrition due to deficiency or excess
Other: Data and samples collection
Collection of clinical, anamnestic and lifestyle data; collection of faecal, blood and saliva samples
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
Other: Data and samples collection
Collection of clinical, anamnestic and lifestyle data; collection of faecal, blood and saliva samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characterization of malnutrition through the identification of specific biomarkers of the condition.
Time Frame: 36 months
Data and samples analyses
36 months
Untargeted microRNA expression profile in blood samples
Time Frame: 36 months
TruSeq Small RNA Sample Preparation Kit (Illumina)
36 months
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.
36 months
Metagenomic analysis of fecal samples
Time Frame: 36 months
Shotgun analysis
36 months
Metabolomicanalysis of fecal samples
Time Frame: 36 months
Gas chromatography-mass spectrometry
36 months
Untargeted microRNA expression profile in saliva samples
Time Frame: 36 months
TruSeq Small RNA Sample Preparation Kit (Illumina)
36 months
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.
36 months
Metagenomic analysis of salivary samples
Time Frame: 36 months
Shotgun analysis
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2023

Primary Completion (Estimated)

July 24, 2026

Study Completion (Estimated)

July 24, 2026

Study Registration Dates

First Submitted

November 22, 2023

First Submitted That Met QC Criteria

November 22, 2023

First Posted (Actual)

December 1, 2023

Study Record Updates

Last Update Posted (Actual)

June 4, 2025

Last Update Submitted That Met QC Criteria

June 3, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2/2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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