The SAM Project: Science Against Malnutrition Project

Malnutrition Clinical Trial

Official title:

The SAM Project: Science Against Malnutrition Project

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06152848
• Other study ID #: 2/2023
• Status: Recruiting
• Start date: July 24, 2023
• Est. completion date: July 24, 2026

Study information

• Verified date: November 2023
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: July 24, 2026
• Est. primary completion date: July 24, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malnutrition

Intervention

Other:
• Data and samples collection
Collection of clinical, anamnestic and lifestyle data; collection of faecal, blood and saliva samples

Locations

Country	Name	City	State
Italy	Department of Traslational Medical Science - University of Naples Federico II	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterization of malnutrition through the identification of specific biomarkers of the condition.	Data and samples analyses	36 months
Primary	Untargeted microRNA expression profile in blood samples	TruSeq Small RNA Sample Preparation Kit (Illumina)	36 months
Primary	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
Primary	Metagenomic analysis of fecal samples	Shotgun analysis	36 months
Primary	Metabolomicanalysis of fecal samples	Gas chromatography-mass spectrometry	36 months
Primary	Untargeted microRNA expression profile in saliva samples	TruSeq Small RNA Sample Preparation Kit (Illumina)	36 months
Primary	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
Primary	Metagenomic analysis of salivary samples	Shotgun analysis	36 months