Pilot Open Label Study With Commercial Supplementation in Healthy Subjects

Supportive Care Clinical Trial

— AUXNUTRIMMUN  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06302842
• Other study ID #: 20J201
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: March 2024
• Source: Istituto Auxologico Italiano
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: April 30, 2024
• Est. primary completion date: October 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Supportive Care

Intervention

Dietary Supplement:
• Bioritmon Immuno Defend
Bioritmon Immuno Defend daily oral preparation for 24 days.

Locations

Country	Name	City	State
Italy	Istituto Auxologico Italiano IRCCS	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in neutrophil chemotaxis	Percentage increase of neutrophil chemotaxis	Basal, after 12 and 24 days treatment
Primary	Change in neutrophil phagocytosis	Percentage increase of neutrophil phagocytosis	Basal, after 12 and 24 days treatment
Primary	Change in neutrophil oxidative burst	Percentage increase of neutrophil oxidative burst	Basal, after 12 and 24 days treatment
Primary	Change in mononuclear CD4pos69pos	Change in percentage of mononuclear CD4pos69pos	Basal, after 12 and 24 days treatment
Primary	Change in mononuclear CD56pos69pos granzymepos	Change in percentage of mononuclear CD56pos69pos granzymepos	Basal, after 12 and 24 days treatment
Primary	Change in plasma cytokine levels	Change in plasma cytokine levels (pg/ml)	Basal, after 12 and 24 days treatment