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Pilot Open Label Study With Commercial Supplementation in Healthy Subjects — AUXNUTRIMMUN  

Supportive Care Clinical Trial

Official title:
Pilot Open Label Study With Commercial Supplementation (Bioritmon Immuno Defend) in Healthy Subjects

Clinical Trial Summary

A bidirectional relationship among nutrition, infection and immunity exists: changes in one component affect the others. Various micronutrients are essential for immunocompetence, particularly vitamins A, C, D, E, B2, B6, and B12, folic acid, iron, selenium, and zinc. Micronutrient deficiencies are a recognized global public health issue, and poor nutritional status predisposes to certain infections. Immune function may be improved by restoring deficient micronutrients to recommended levels, thereby increasing resistance to infection and supporting faster recovery when infected. Diet alone may be insufficient and tailored micronutrient supplementation based on specific age-related needs is necessary. Aim of the study is to investigate whether nutrient supplementation may affect different functional parameters of the innate and adaptive immunity.

Clinical Trial Description

Study objective: The study is designed to evaluate the effects of Bioritmon Immuno Defend on the immune response of healthy subjects. The following parameters will be evaluated: - PBMC proliferative response to polyclonal mitogens as described - Expression of CD69 on mononuclear cells by flow cytometry before and after polyclonal stimulation as described - Th1/Th2 cytokine cytoplasmic expression in PBMC before and after polyclonal stimulation - Evaluation of NK cytotoxicity by NKTEST Tm BD Biosciences - Evaluation of neutrophil phagocytic activity by PHAGOTESTTm BD Biosciences - Evaluation of neutrophil oxidative burst by PHAGOBURST Tm BD Biosciences - Evaluation of neutrophil chemotaxis by MIGRATEST Tm BD Biosciences - Measurement of serum cytokines (IL2, IL4, IL6, IL10, IFNgamma, TNF) by solid phase assay as described ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06302842
Study type Interventional
Source Istituto Auxologico Italiano
Contact
Status Active, not recruiting
Phase N/A
Start date July 1, 2023
Completion date April 30, 2024
View Details
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