Oral Supplementation With AM3, Hesperidin and Spermidine Supplementation on Immunity Response and Biological Age.

Healthy Clinical Trial

Official title:

A Randomized Controlled Trial of Oral Suplementation With AM3, Hesperidin and Spermidine on Immunity Response and Biological Age in Healthy Volunteers.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06249620
• Other study ID #: P21110b
• Status: Completed
• Phase: N/A
• Start date: April 19, 2022
• Est. completion date: October 1, 2022

Study information

• Verified date: January 2024
• Source: Industrial Farmacéutica Cantabria, S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this interventional study is to know the immune status of healthy participants and to obtain their biological age before and after two months of ingesting a dietary supplement. These individuals are compared with others who will be given a product of similar appearance, but without containing active components, being the constituents of the placebo group.

The study has a duration of 8 weeks, with 2 interventional visits (complete blood samples will be collected) at baseline and at 8 weeks.

In order to be included in the trial, the patient must read the Patient Information Sheet and sign the informed consent form.

The dosage regimen is two capsules per day in a single dose.

Description:

Forty consenting volunteers will be included in this prospective, randomized, double-blind study and will be randomized by a statistician independent of the research team.

The study consists of two milestones, in which different parameters are evaluated to finally reach the main goal, to measure their immune status and their biological age after taking the supplement (whose active ingredients include AM3, polyamines and flavonoids):

• Complete blood samples are collected from participants at milestone 1. To determine immune functions; neutrophils, lymphocytes and NK cells are measured. The adherence and chemotaxis capacity of neutrophils and lymphocytes is determined, as well as neutrophil phagocytosis and lymphocyte proliferation. In addition, the release of pro-inflammatory and anti-inflammatory cytokines is assessed.

In parallel, each participant will be given a survey to assess their perception of stress, which they will have to complete before and after 2 months of ingestion of the product (experimental and placebo).

• In milestone 2, oxidative and inflammatory stress parameters are analyzed. Regarding oxidative stress: catalase activity, glutathione reductase activity and reduced glutathione concentration are measured. In terms of inflammatory stress: concentrations of both proinflammatory and anti-inflammatory cytokines released are measured.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: October 1, 2022
• Est. primary completion date: July 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 29 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy volunteers who give their consent for the study will be included after having read and understood the information provided in the informed consent document

• Between 29-65 years old

• Residents in the Community of Madrid

Exclusion Criteria:

• Volunteers with no allergies or intolerances to the product

• Patologies

• Excessive alcohol consumption

• Pregnant women

• Antioxidants intake from supplements

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Inmunoferon
The dosage regimen is two capsules (with the active ingredients) per day in a single dose.The study lasted 8 weeks, with 2 interventional visits at baseline and at 8 weeks. Blood samples are collected twice: once on day 0 of the study and again at the final visit.
• Placebo
The dosage regimen is two capsules (with inert ingredients) per day in a single dose.The study lasted 8 weeks, with 2 interventional visits at baseline and at 8 weeks. Blood samples are collected twice: once on day 0 of the study and again at the final visit.

Locations

Country	Name	City	State
Spain	Facultad de Biología Universidad Complutense de Madrid	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Industrial Farmacéutica Cantabria, S.A.

Country where clinical trial is conducted

Spain, 

References & Publications (48)

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* Note: There are 48 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Biological Age	The Biological Age will be determined at baseline and week 8, by using the mathematical model 'Immunity Clock', based on the the natural killer activity, Lymphoproliferation and phagocytosis, and neutrophils and lymphocyts chemotaxis	Baseline and Week 8
Secondary	Change in catalase activity with the use of a spectrophotometer	Measuring catalase activity with the use of a spectrophotometer will be used to assess oxidative stress at baseline and week 8 of treatment.	Baseline and week 8
Secondary	Change in Glutathione peroxidase levels	To determine glutathione peroxidase levels at baseline and week 8 to asseess oxidative stress.	Baseline and week 8
Secondary	Change in Glutathione reductase levels	To determine glutathione reductase levels at baseline and week 8 to assess oxidative stress.	Baseline and week 8
Secondary	Change in reduced/oxized glutathione concentrations (GSH/GSSG)	To determine educed/oxized glutathione concentrations at baseline and week 8 to asseess oxidative stress.	Baseline and week 8
Secondary	Change in inflammatory and anti-inflammatory cytokines levels	To determine levels of both inflammatory and anti-inflammatory cytokines at baseline and week 8 for evaluation of inflammatory stress.	Baseline and week 8
Secondary	Change in Malondialdehyde concentrations	To determine concentration levels of malondialdehyde at baseline and at week 8 to evaluate peroxidative damage.	Baseline and week 8
Secondary	Change in neutrophil levels	To determine neutrophil levels at baseline and week 8 to analyze the immunological functions.	Baseline and week 8
Secondary	Change in lymphocyte levels	To determine lymphocite levels at baseline and week 8 to analyze the immunological functions.	Baseline and week 8
Secondary	Change in cytotoxic activity of natural killer	The cytotoxic activity of NK cells was assessed by colorimetry of target cell lysis at baseline and week 8 of tretment to analyze the immunological functions.	Baseline and week 8
Secondary	Change in chemotaxis index	To analyze the immunological functions, the chemotaxis index was calculated at baseline and week 8 to assess the migration capacity of neutrophils and lymphocytes .	Baseline and week 8
Secondary	Change in lymphoproliferation levels	To analyze the immunological functions, lymphoproliferation capacity by neutrophils was measured at baseline and week 8.	Baseline and week 8
Secondary	Change in phagocytosis activity	To analyze the immunological functions, phagocytosis activity by the neutrophils will also be determined at baseline and week 8 of treatment.; Phagocytosis is a critical biological activity through which the host can protect itself from infectious and non-infectious environmental particles and remove unwanted host cells in order to maintain tissue homeostasis.	Baseline and week 8

External Links

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