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NCT Number: NCT06152848

The SAM Project: Science Against Malnutrition Project

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.

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Key information

Conditions

Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

0 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Traslational Medical Science - University of Naples Federico II

Naples, 80131, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Data and samples collection

Other

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

Primary outcomes

  1. Characterization of malnutrition through the identification of specific biomarkers of the condition.

    Time frame: 36 months

    Data and samples analyses

  2. Untargeted microRNA expression profile in blood samples

    Time frame: 36 months

    TruSeq Small RNA Sample Preparation Kit (Illumina)

  3. Plasmatic extracellular vesicles

    Time frame: 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.

  4. Metagenomic analysis of fecal samples

    Time frame: 36 months

    Shotgun analysis

  5. Metabolomicanalysis of fecal samples

    Time frame: 36 months

    Gas chromatography-mass spectrometry

  6. Untargeted microRNA expression profile in saliva samples

    Time frame: 36 months

    TruSeq Small RNA Sample Preparation Kit (Illumina)

  7. Salivary extracellular vesicles

    Time frame: 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.

  8. Metagenomic analysis of salivary samples

    Time frame: 36 months

    Shotgun analysis

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 1, 2023
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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