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| Name | Class |
|---|---|
| Macrofarm Srl | INDUSTRY |
| Icim International Srl | UNKNOWN |
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The aim of the study is to verify the effectiveness of Nutraceutical IMMU·SYSTEM Dietary supplement in reducing the levels of oxidative stress and inflammation in a sample of healthy adult subjects with high baseline levels of oxidative stress.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary supplement | Active Comparator | One cp/day of the IMMUSYSTEM food supplement for 3 months |
|
| Placebo | Placebo Comparator | One cp/day of Placebo for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immusystem | Dietary Supplement | Dietary supplement containing: Piceid, Glycine, Glutamine, Acetylcysteine, Zinc and Vitamin B6 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Erythrocytes GSH/GSSG ratio | Change from Baseline reduced/oxidized glutathione ratio in erythrocytes at 3 Months | Month 3 |
| Change in Erythrocytes GSH/GSSG ratio | Change from Baseline reduced/oxidized glutathione ratio in erythrocytes at 1st Month | Month 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Immune system activity | Change from Baseline of Serum levels of immune system activity: TNFα, IL-6, IL-2 at 3 Months | Month 3 |
| Change in Immune system activity | Change from Baseline of Serum levels of immune system activity: TNFα, IL-6, IL-2 at 1st Month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francesco Puoci, PhD | DFSSN - UNICAL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calabria | Rende | CS | 87036 | Italy |
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| Placebo | Other | Maltodextrin placebo capsule |
|
| Month 1 |
| Change in Immune system activity | Change from Baseline of Serum levels of IFN-γ at 1st Month | Month 3 |
| Change in Immune system activity | Change from Baseline of Serum levels of IFN-γ at 1st Month | Month 1 |