Oral Supplementation With AM3, Hesperidin and Spermidine Supplementation on Immunity Response and Biological Age.
Condition: Healthy
Study type: Interventional

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.
    

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.
    

Intervention name(s): Inmunoferon; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 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.; 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.
Intervention MeSH terms: Immunoferon
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: AM3; Biological age; Inmunology clock; Spermidine; Hesperidin