Pilot Open Label Study With Commercial Supplementation in Healthy Subjects

NCT ID: NCT06302842

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2024-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Before and after treatment

Nutraceutical (Bioritmon Immuno Defend), one oral preparation daily for 24 days.

Immunological parameters are investigated before and after the treatment.

Group Type: EXPERIMENTAL

Bioritmon Immuno Defend

Intervention Type: DIETARY_SUPPLEMENT

Bioritmon Immuno Defend daily oral preparation for 24 days.

Interventions

Bioritmon Immuno Defend

Bioritmon Immuno Defend daily oral preparation for 24 days.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Informed consent:
• Cooperative volunteers
• normal physical examination
• Female subjects: must not be pregnant, breastfeeding, or at risk to become pregnant during study participation. Female patients of childbearing potential, must test negative for pregnancy at the time of enrollment and agree to use a reliable method of birth control or remain abstinent during the study or for at least 30 days following the last dose of study drug, whichever is longer, or, must be a female of non-childbearing potential, defined as:
• women who have had surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation),
• women ≥60 years of age, or women ≥40 and <60 years of age who have had a cessation of menses for at least 12 months and a follicle-stimulating hormone (FSH) test confirming non-childbearing potential (FSH ≥40 mIU/mL).
• Have a negative COVID-19 antigen rapid test

Exclusion Criteria

• Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study (i.e. Body Mass Index > 30, body temperature > 37,5°C)
• Diseases: Diabetes, cardiovascular, kidney, liver or lung diseases incompatible with exercise, active infections and cancer; angina pectoris or congestive heart failure in New York Heart Association class III-IV, severe chronic pulmonary disease, severe symptomatic obliterating arteriosclerosis, muscle- skeletal or cerebrovascular diseases incompatible with exercise training, drug or alcohol dependence and severe mental disease or any concurrent medical condition that, in the judgment of the PI, might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the patient's well-being.
• Treatment with any investigational product (IP) during the study and within the 3 months (or at least 5 half-lives, whichever is longer) prior to Visit 1.
• Concomitant food supplements with Vitamins/lactoferrin or any other supplement, considered exclusionary by the PI and faculty physician, need to be avoided during the study.
• History of intolerance hypersensitivity or allergy to any of the component of the IP formulation.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istituto Auxologico Italiano

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pier luigi Meroni

Role: PRINCIPAL_INVESTIGATOR

Istituto Auxologico Italiano

Locations

Istituto Auxologico Italiano IRCCS

Milan, , Italy

Countries

Italy

Other Identifiers

20J201

Identifier Type: -

Identifier Source: org_study_id