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

Cantabria Labs

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Inmunoferon

Study type: Interventional

Funder types: Industry

Identifiers

NCT06249620

P21110b

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 29 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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41 participants in 2 patient groups, including a placebo group

Active group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Inmunoferon

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo