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

January 31, 2024 updated by: Industrial Farmacéutica Cantabria, S.A.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Facultad de Biología Universidad Complutense de Madrid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active group
The product (with the active ingredients) is randomly given to 20 participants for ingestion for two months.The dosage regimen is two capsules per day in a single dose.
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 Comparator: Placebo
The other 20 participants will receive a similar looking product but with inert substances (placebo group).The dosage regimen is two capsules per day in a single dose.
Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Biological Age
Time Frame: Baseline and Week 8
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in catalase activity with the use of a spectrophotometer
Time Frame: Baseline and week 8
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
Change in Glutathione peroxidase levels
Time Frame: Baseline and week 8
To determine glutathione peroxidase levels at baseline and week 8 to asseess oxidative stress.
Baseline and week 8
Change in Glutathione reductase levels
Time Frame: Baseline and week 8
To determine glutathione reductase levels at baseline and week 8 to assess oxidative stress.
Baseline and week 8
Change in reduced/oxized glutathione concentrations (GSH/GSSG)
Time Frame: Baseline and week 8
To determine educed/oxized glutathione concentrations at baseline and week 8 to asseess oxidative stress.
Baseline and week 8
Change in inflammatory and anti-inflammatory cytokines levels
Time Frame: Baseline and week 8
To determine levels of both inflammatory and anti-inflammatory cytokines at baseline and week 8 for evaluation of inflammatory stress.
Baseline and week 8
Change in Malondialdehyde concentrations
Time Frame: Baseline and week 8
To determine concentration levels of malondialdehyde at baseline and at week 8 to evaluate peroxidative damage.
Baseline and week 8
Change in neutrophil levels
Time Frame: Baseline and week 8
To determine neutrophil levels at baseline and week 8 to analyze the immunological functions.
Baseline and week 8
Change in lymphocyte levels
Time Frame: Baseline and week 8
To determine lymphocite levels at baseline and week 8 to analyze the immunological functions.
Baseline and week 8
Change in cytotoxic activity of natural killer
Time Frame: Baseline and week 8
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
Change in chemotaxis index
Time Frame: Baseline and week 8
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
Change in lymphoproliferation levels
Time Frame: Baseline and week 8
To analyze the immunological functions, lymphoproliferation capacity by neutrophils was measured at baseline and week 8.
Baseline and week 8
Change in phagocytosis activity
Time Frame: Baseline and week 8

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Industrial Farmacéutica Cantabria, S.A.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2022

Primary Completion (Actual)

July 11, 2022

Study Completion (Actual)

October 1, 2022

Study Registration Dates

First Submitted

July 25, 2023

First Submitted That Met QC Criteria

January 31, 2024

First Posted (Actual)

February 8, 2024

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P21110b

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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