The SAM Project: Science Against Malnutrition Project
- Conditions
- Malnutrition
- Interventions
- Other: Data and samples collection
- Registration Number
- NCT06152848
- Lead Sponsor
- Federico II University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2000
- 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
- Non-Caucasian ethnicity;
- Age > 85 years.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients affected by malnutrition Data and samples collection Patients affected by malnutrition due to deficiency or excess Sex- and age- matched healthy controls Data and samples collection Sex- and age- matched healthy controls not affected by any pathology and/or malnutrition due to deficiency or excess
- Primary Outcome Measures
Name Time Method Untargeted microRNA expression profile in blood samples 36 months TruSeq Small RNA Sample Preparation Kit (Illumina)
Plasmatic extracellular vesicles 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.
Characterization of malnutrition through the identification of specific biomarkers of the condition. 36 months Data and samples analyses
Metabolomicanalysis of fecal samples 36 months Gas chromatography-mass spectrometry
Metagenomic analysis of fecal samples 36 months Shotgun analysis
Untargeted microRNA expression profile in saliva samples 36 months TruSeq Small RNA Sample Preparation Kit (Illumina)
Salivary extracellular vesicles 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.
Metagenomic analysis of salivary samples 36 months Shotgun analysis
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Traslational Medical Science - University of Naples Federico II
🇮🇹Naples, Italy