An observational study in Malnutrition, sponsored by Federico II University. Completed at 1 site in Italy. Open to participants aged 0 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Federico II University · Observational
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.
1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.
This study's enrollment of 2,000 is above the median of 203 across 388 observational studies indexed under Malnutrition.
Browse Malnutrition studies →Federico II University is the lead sponsor of 356 studies on the registry; 60 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Patients affected by malnutrition due to deficiency or excess
Other: Data and samples collection
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
Characterization of malnutrition through the identification of specific biomarkers of the condition.
Data and samples analyses
Time frame: 36 months
Untargeted microRNA expression profile in blood samples
TruSeq Small RNA Sample Preparation Kit (Illumina)
Time frame: 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.
Time frame: 36 months
Metagenomic analysis of fecal samples
Shotgun analysis
Time frame: 36 months
Metabolomicanalysis of fecal samples
Gas chromatography-mass spectrometry
Time frame: 36 months
Untargeted microRNA expression profile in saliva samples
TruSeq Small RNA Sample Preparation Kit (Illumina)
Time frame: 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.
Time frame: 36 months
Metagenomic analysis of salivary samples
Shotgun analysis
Time frame: 36 months
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Federico II University