The SAM Project: Science Against Malnutrition Project

Study Overview
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Brief Summary
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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.

Official Title
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The SAM Project: Science Against Malnutrition Project

Conditions
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Malnutrition

Intervention / Treatment
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* Other: Data and samples collection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients affected by malnutrition<br>Patients affected by malnutrition due to deficiency or excess | Other: Data and samples collection<br>* Collection of clinical, anamnestic and lifestyle data; collection of faecal, blood and saliva samples<br>|
| Sex- and age- matched healthy controls<br>Sex- and age- matched healthy controls not affected by any pathology and/or malnutrition due to deficiency or excess | Other: Data and samples collection<br>* Collection of clinical, anamnestic and lifestyle data; collection of faecal, blood and saliva samples<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 36 months | 
| Metagenomic analysis of salivary samples | Shotgun analysis | 36 months |