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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients affected by malnutrition | Patients affected by malnutrition due to deficiency or excess |
| |
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Data and samples collection | Other | Collection of clinical, anamnestic and lifestyle data; collection of faecal, blood and saliva samples |
|
| Measure | Description | Time Frame |
|---|---|---|
| Characterization of malnutrition through the identification of specific biomarkers of the condition. | Data and samples analyses | 36 months |
| Untargeted microRNA expression profile in blood samples | TruSeq Small RNA Sample Preparation Kit (Illumina) | 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. | 36 months |
| Metagenomic analysis of fecal samples | Shotgun analysis | 36 months |
| Metabolomicanalysis of fecal samples | Gas chromatography-mass spectrometry | 36 months |
| Untargeted microRNA expression profile in saliva samples | TruSeq Small RNA Sample Preparation Kit (Illumina) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Traslational Medical Science - University of Naples Federico II | Recruiting | Naples | 80131 | Italy |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| 36 months |
| Metagenomic analysis of salivary samples | Shotgun analysis | 36 months |