The SAM Project: Science Against Malnutrition Project
1 other identifier
observational
2,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 24, 2023
CompletedFirst Submitted
Initial submission to the registry
November 22, 2023
CompletedFirst Posted
Study publicly available on registry
December 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 24, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 24, 2026
June 4, 2025
June 1, 2025
3 years
November 22, 2023
June 3, 2025
Conditions
Outcome Measures
Primary Outcomes (8)
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
Study Arms (2)
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
Interventions
Collection of clinical, anamnestic and lifestyle data; collection of faecal, blood and saliva samples
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Non-Caucasian ethnicity;
- Age \> 85 years.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Traslational Medical Science - University of Naples Federico II
Naples, 80131, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor, PhD, Professor
Study Record Dates
First Submitted
November 22, 2023
First Posted
December 1, 2023
Study Start
July 24, 2023
Primary Completion (Estimated)
July 24, 2026
Study Completion (Estimated)
July 24, 2026
Last Updated
June 4, 2025
Record last verified: 2025-06