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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active group | Experimental | 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. |
|
| Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Biological Age | 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 | Baseline and Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in catalase activity with the use of a spectrophotometer | Measuring catalase activity with the use of a spectrophotometer will be used to assess oxidative stress at baseline and week 8 of treatment. | Baseline and week 8 |
| Change in Glutathione peroxidase levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Facultad de Biología Universidad Complutense de Madrid | Madrid | 28040 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2313042 | Result | Wayne SJ, Rhyne RL, Garry PJ, Goodwin JS. Cell-mediated immunity as a predictor of morbidity and mortality in subjects over 60. J Gerontol. 1990 Mar;45(2):M45-8. doi: 10.1093/geronj/45.2.m45. | |
| 19754376 | Result | De la Fuente M, Miquel J. An update of the oxidation-inflammation theory of aging: the involvement of the immune system in oxi-inflamm-aging. Curr Pharm Des. 2009;15(26):3003-26. doi: 10.2174/138161209789058110. |
| Label | URL |
|---|---|
| Oxidation and Inflammation in the Immune and Nervous Systems, a Link Between Aging and Anxiety | View source |
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| ID | Term |
|---|---|
| C038773 | Immunoferon |
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|
| 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. |
|
To determine glutathione peroxidase levels at baseline and week 8 to asseess oxidative stress. |
| Baseline and week 8 |
| Change in Glutathione reductase levels | To determine glutathione reductase levels at baseline and week 8 to assess oxidative stress. | Baseline and week 8 |
| Change in reduced/oxized glutathione concentrations (GSH/GSSG) | To determine educed/oxized glutathione concentrations at baseline and week 8 to asseess oxidative stress. | Baseline and week 8 |
| Change in inflammatory and anti-inflammatory cytokines levels | To determine levels of both inflammatory and anti-inflammatory cytokines at baseline and week 8 for evaluation of inflammatory stress. | Baseline and week 8 |
| Change in Malondialdehyde concentrations | To determine concentration levels of malondialdehyde at baseline and at week 8 to evaluate peroxidative damage. | Baseline and week 8 |
| Change in neutrophil levels | To determine neutrophil levels at baseline and week 8 to analyze the immunological functions. | Baseline and week 8 |
| Change in lymphocyte levels | To determine lymphocite levels at baseline and week 8 to analyze the immunological functions. | Baseline and week 8 |
| Change in cytotoxic activity of natural killer | 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. | Baseline and week 8 |
| Change in chemotaxis index | To analyze the immunological functions, the chemotaxis index was calculated at baseline and week 8 to assess the migration capacity of neutrophils and lymphocytes . | Baseline and week 8 |
| Change in lymphoproliferation levels | To analyze the immunological functions, lymphoproliferation capacity by neutrophils was measured at baseline and week 8. | Baseline and week 8 |
| Change in phagocytosis activity | 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. | Baseline and week 8 |
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| Estrategias para enlentecer el envejecimiento en modelos de ratón y en humanos. Efectos sobre la longevidad y la edad biológica | View source |