The SAM Project: Science Against Malnutrition Project

Federico II University2,000 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

2,000

Conditions

Malnutrition

Interventions

Data and samples collectionOTHER

Collection of clinical, anamnestic and lifestyle data; collection of faecal, blood and saliva samples

Eligibility

Sex: ALLMin age: 0 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (1)

Department of Traslational Medical Science - University of Naples Federico II

Naples, Naples, Italy

Outcomes

Primary Outcomes

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

Time frame: 36 months

Metagenomic analysis of salivary samples

Shotgun analysis

Time frame: 36 months

Data from ClinicalTrials.gov

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