Supportive CareAUXNUTRIMMUNNCT06302842
Pilot Open Label Study With Commercial Supplementation in Healthy Subjects
A study testing Bioritmon Immuno Defend in people with Supportive Care, run by Istituto Auxologico Italiano at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Supportive Care
- What is being tested?
- Bioritmon Immuno Defend
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Open Label Study With Commercial Supplementation (Bioritmon Immuno Defend) in Healthy Subjects
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.
Read the 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
- Being tested
- Bioritmon Immuno Defend
- Keywords
- Micronutrients, Innate immunity, Adaptive immunity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioritmon Immuno DefendDietary supplement
Bioritmon Immuno Defend daily oral preparation for 24 days.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Bioritmon Immuno Defend |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in neutrophil chemotaxis
Percentage increase of neutrophil chemotaxis
Measured: Basal, after 12 and 24 days treatment
Change in neutrophil phagocytosis
Percentage increase of neutrophil phagocytosis
Measured: Basal, after 12 and 24 days treatment
Change in neutrophil oxidative burst
Percentage increase of neutrophil oxidative burst
Measured: Basal, after 12 and 24 days treatment
Change in mononuclear CD4pos69pos
Change in percentage of mononuclear CD4pos69pos
Measured: Basal, after 12 and 24 days treatment
Change in mononuclear CD56pos69pos granzymepos
Change in percentage of mononuclear CD56pos69pos granzymepos
Measured: Basal, after 12 and 24 days treatment
Change in plasma cytokine levels
Change in plasma cytokine levels (pg/ml)
Measured: Basal, after 12 and 24 days treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start1 Jul 2023
- Primary completion15 Oct 2023
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supportive CareStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pier luigi Meroni, Principal investigator, Istituto Auxologico Italiano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06302842
- Sponsor's protocol ID
- 20J201
- Acronym
- AUXNUTRIMMUN
- Status last verified
- Apr 2025
- First submitted
- 4 Mar 2024
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Open Label Study With Commercial Supplementation (Bioritmon Immuno Defend) in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06302842
- Acronym / sponsor ID
- AUXNUTRIMMUN / 20J201
- Conditions
- Supportive Care
- Keywords
- Micronutrients, Innate immunity, Adaptive immunity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 15 Oct 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Before and after treatment | Experimental | Dietary Supplement: Bioritmon Immuno DefendNutraceutical (Bioritmon Immuno Defend), one oral preparation daily for 24 days. Immunological parameters are investigated before and after the treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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),
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bioritmon Immuno DefendBioritmon Immuno Defend daily oral preparation for 24 days. | Dietary supplement | Before and after treatment |
Primary outcome
Change in neutrophil chemotaxis
Time frame: Basal, after 12 and 24 days treatment
Percentage increase of neutrophil chemotaxis
Change in neutrophil phagocytosis
Time frame: Basal, after 12 and 24 days treatment
Percentage increase of neutrophil phagocytosis
Change in neutrophil oxidative burst
Time frame: Basal, after 12 and 24 days treatment
Percentage increase of neutrophil oxidative burst
Change in mononuclear CD4pos69pos
Time frame: Basal, after 12 and 24 days treatment
Change in percentage of mononuclear CD4pos69pos
Change in mononuclear CD56pos69pos granzymepos
Time frame: Basal, after 12 and 24 days treatment
Change in percentage of mononuclear CD56pos69pos granzymepos
Change in plasma cytokine levels
Time frame: Basal, after 12 and 24 days treatment
Change in plasma cytokine levels (pg/ml)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pier luigi Meroni principal investigator
Istituto Auxologico Italiano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bioritmon Immuno Defend in people with Supportive Care, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in neutrophil chemotaxis (time frame: Basal, after 12 and 24 days treatment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.