Pilot Open Label Study With Commercial Supplementation in Healthy Subjects

NCT06302842 | Completed

• 1 other identifier: 20J201
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Supportive Care

Keywords

Micronutrients; Innate immunity; Adaptive immunity

Outcome Measures

Primary Outcomes (6)

• Change in neutrophil chemotaxis

  Percentage increase of neutrophil chemotaxis

  Basal, after 12 and 24 days treatment

• Change in neutrophil phagocytosis

  Percentage increase of neutrophil phagocytosis

  Basal, after 12 and 24 days treatment

• Change in neutrophil oxidative burst

  Percentage increase of neutrophil oxidative burst

  Basal, after 12 and 24 days treatment

• Change in mononuclear CD4pos69pos

  Change in percentage of mononuclear CD4pos69pos

  Basal, after 12 and 24 days treatment

• Change in mononuclear CD56pos69pos granzymepos

  Change in percentage of mononuclear CD56pos69pos granzymepos

  Basal, after 12 and 24 days treatment

• Change in plasma cytokine levels

  Change in plasma cytokine levels (pg/ml)

  Basal, after 12 and 24 days treatment

Study Arms (1)

Before and after treatment

EXPERIMENTAL

Nutraceutical (Bioritmon Immuno Defend), one oral preparation daily for 24 days. Immunological parameters are investigated before and after the treatment.

Dietary Supplement: Bioritmon Immuno Defend

Interventions

Bioritmon Immuno Defend DIETARY_SUPPLEMENT

Bioritmon Immuno Defend daily oral preparation for 24 days.

Before and after treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• History of intolerance hypersensitivity or allergy to any of the component of the IP formulation.

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

Istituto Auxologico Italiano IRCCS

Milan, 20145, Italy

Location

Study Officials

• Pier luigi Meroni

  Istituto Auxologico Italiano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 12, 2024
• Study Start: July 1, 2023
• Primary Completion: October 15, 2023
• Study Completion: December 31, 2024
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)