The SAM Project: Science Against Malnutrition Project
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Data and samples collection.
- Who it may be relevant to
- Registry conditions: Malnutrition. Basic parameters: 0 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
Interventions
- Other Data and samples collection
Collection of clinical, anamnestic and lifestyle data; collection of faecal, blood and saliva samples
Primary outcome measures
- Characterization of malnutrition through the identification of specific biomarkers of the condition. [Time frame: 36 months]
- Untargeted microRNA expression profile in blood samples [Time frame: 36 months]
- Plasmatic extracellular vesicles [Time frame: 36 months]
- Metagenomic analysis of fecal samples [Time frame: 36 months]
- Metabolomicanalysis of fecal samples [Time frame: 36 months]
- Untargeted microRNA expression profile in saliva samples [Time frame: 36 months]
- Salivary extracellular vesicles [Time frame: 36 months]
- Metagenomic analysis of salivary samples [Time frame: 36 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Italy · 1 center
- Department of Traslational Medical Science - University of Naples Federico II — Naples
Identifiers
NCT: NCT06152848 · 2/2023