Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06249620
Status:
COMPLETED
Last Update Posted:
2024-02-08
First Post:
2023-07-25
Brief Title:
Oral Supplementation With AM3 Hesperidin and Spermidine Supplementation on Immunity Response and Biological Age
Sponsor:
Industrial Farmacéutica Cantabria SA
Organization:
Industrial Farmacéutica Cantabria SA
Study Overview
Official Title:
A Randomized Controlled Trial of Oral Suplementation With AM3 Hesperidin and Spermidine on Immunity Response and Biological Age in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None