The SAM Project: Science Against Malnutrition Project

NCT ID: NCT06152848

Last Updated: 2025-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-24

Study Completion Date

2026-07-24

Brief Summary

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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

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Conditions

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Malnutrition

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients affected by malnutrition

Patients affected by malnutrition due to deficiency or excess

Data and samples collection

Intervention Type OTHER

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

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

Data and samples collection

Intervention Type OTHER

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

Interventions

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Data and samples collection

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

0 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federico II University

OTHER

Sponsor Role lead

Responsible Party

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Roberto Berni Canani, MD, PhD

Medical Doctor, PhD, Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Traslational Medical Science - University of Naples Federico II

Naples, , Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Roberto Berni Canani, MD, PhD

Role: primary

0817462680

Other Identifiers

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2/2023

Identifier Type: -

Identifier Source: org_study_id

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