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Completed

NCT Number: NCT06249620

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

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.

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Key information

Conditions

Healthy

Age range

29 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Facultad de Biología Universidad Complutense de Madrid

Madrid, 28040, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inmunoferon

Dietary Supplement

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

Dietary Supplement

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Change in neutrophil levels

    Time frame: Baseline and week 8

    To determine neutrophil levels at baseline and week 8 to analyze the immunological functions.

  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.

  9. 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.

  10. 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 .

  11. 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.

  12. 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.

Sponsors and collaborators

Lead sponsor

Industrial Farmacéutica Cantabria, S.A.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 8, 2024
Registry last updated
Feb 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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