Loading clinical trials...

Pilot Open Label Study With Commercial Supplementation in Healthy Subjects | Clinical Trials | Clareo Health

COMPLETEDNA

Pilot Open Label Study With Commercial Supplementation in Healthy Subjects

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

NCT06302842•Istituto Auxologico Italiano

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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.

Locations (1)

Istituto Auxologico Italiano IRCCS

Milan, Italy

Key Dates

Start Date

July 1, 2023

Primary Completion Date

October 15, 2023

Completion Date

December 31, 2024

Last Updated

April 30, 2025

Enrollment

ACTUAL participants

Conditions

Supportive Care

Interventions

Bioritmon Immuno Defend

DIETARY_SUPPLEMENT

Supportive Care Needs of Caregivers of People With Erdheim-Chester Disease and Other Histiocytic Diseases

NCT03990428

Supportive Care Needs of Caregivers

View study

RECRUITINGNA

The Effect of Oculomotor Exercises in the Warm-up on Forehand and Backhand Stroke Performance in Tennis Players

NCT06311747

Supportive Care

View study

ENROLLING_BY_INVITATION

Pharmacogenomics to Improve Supportive Care Symptoms.

NCT06856122

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Pilot Open Label Study With Commercial Supplementation in Healthy Subjects

Inclusion Criteria

Exclusion Criteria

Supportive Care Needs of Caregivers of People With Erdheim-Chester Disease and Other Histiocytic Diseases

The Effect of Oculomotor Exercises in the Warm-up on Forehand and Backhand Stroke Performance in Tennis Players

Pharmacogenomics to Improve Supportive Care Symptoms.

Optimize the Support of Patients in Pelvic Onco-gynecology Through Adapted Support Care in the Post-cancer Period. AFTERGYN Pilot Phase

Clinical Decision Support to Increase Use of Medications for Opioid Use Disorder

Mouthwash Temperature and Oral Mucositis in Head and Neck Radiotherapy