The SAM Project: Science Against Malnutrition Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- Untargeted microRNA expression profile in blood samples
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Non-Caucasian ethnicity;
- •Age > 85 years.
研究组 & 干预措施
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
干预措施: Data and samples collection (Other)
Patients affected by malnutrition
Patients affected by malnutrition due to deficiency or excess
干预措施: Data and samples collection (Other)
结局指标
主要结局
Untargeted microRNA expression profile in blood samples
时间窗: 36 months
TruSeq Small RNA Sample Preparation Kit (Illumina)
Plasmatic extracellular vesicles
时间窗: 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.
Characterization of malnutrition through the identification of specific biomarkers of the condition.
时间窗: 36 months
Data and samples analyses
Metabolomicanalysis of fecal samples
时间窗: 36 months
Gas chromatography-mass spectrometry
Metagenomic analysis of fecal samples
时间窗: 36 months
Shotgun analysis
Untargeted microRNA expression profile in saliva samples
时间窗: 36 months
TruSeq Small RNA Sample Preparation Kit (Illumina)
Salivary extracellular vesicles
时间窗: 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.
Metagenomic analysis of salivary samples
时间窗: 36 months
Shotgun analysis
次要结局
未报告次要终点
研究者
Roberto Berni Canani, MD, PhD
Medical Doctor, PhD, Professor
Federico II University