NCT06249620

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Industrial Farmacéutica Cantabria, S.A. · Industry
• Sex: All
• Age: 29 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2022-04-19
• Primary completion: 2022-07-11
• Completion: 2022-10-01
• First posted: 2024-02-08
• Last updated: 2024-02-08

Locations

1 site across 1 country: Spain