NCT06302842

Pilot Open Label Study With Commercial Supplementation in Healthy Subjects

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Istituto Auxologico Italiano · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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

Conditions

• Supportive Care

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Bioritmon Immuno Defend	Bioritmon Immuno Defend daily oral preparation for 24 days.

Timeline

• Start date: 2023-07-01
• Primary completion: 2023-10-15
• Completion: 2024-12-31
• First posted: 2024-03-12
• Last updated: 2025-04-30

Locations

1 site across 1 country: Italy