EValuation of the Antioxidant and Anti-inflammatory Capacity of Nutraceutical IMMU·SYSTEM Food Supplement (EVAANIS)

Study Overview
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Brief Summary
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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.

Official Title
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EValuation of the Antioxidant and Anti-inflammatory Capacity of Nutraceutical IMMU·SYSTEM Food Supplement (EVAANIS)

Conditions
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Oxidative Stress

Intervention / Treatment
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* Dietary Supplement: Immusystem
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Caucasian ethnicity; Age between 30 and 65 years; Smokers who have smoked at least 100 cigarettes in their lifetime and smoke at least 10 cigarettes a day; Sportsmen who have been playing sports for at least 6 months between 4 and 8 hours per week; Signature of informed consent. Exclusion Criteria: Systemic pathologies; Active drug therapy; Estrogen-progestogen therapy; Pregnancy; Allergies to the components of the raw material under study.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dietary supplement<br>One cp/day of the IMMUSYSTEM food supplement for 3 months | Dietary Supplement: Immusystem<br>* Dietary supplement containing: Piceid, Glycine, Glutamine, Acetylcysteine, Zinc and Vitamin B6<br>|
| Placebo Comparator: Placebo<br>One cp/day of Placebo for 3 months | Other: Placebo<br>* Maltodextrin placebo capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oxidative Stress, Glutathione, Immune system activity, Food supplement