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

Complife Italia Srl60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Oxidative Stress

Interventions

ImmusystemDIETARY_SUPPLEMENT

Dietary supplement containing: Piceid, Glycine, Glutamine, Acetylcysteine, Zinc and Vitamin B6

PlaceboOTHER

Maltodextrin placebo capsule

Eligibility

Sex: ALLMin age: 30 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University of Calabria

Rende, CS, Italy

Outcomes

Primary Outcomes

Change in Erythrocytes GSH/GSSG ratio

Change from Baseline reduced/oxidized glutathione ratio in erythrocytes at 3 Months

Time frame: Month 3

Change in Erythrocytes GSH/GSSG ratio

Change from Baseline reduced/oxidized glutathione ratio in erythrocytes at 1st Month

Time frame: Month 1

Secondary Outcomes

Change in Immune system activity

Change from Baseline of Serum levels of immune system activity: TNFα, IL-6, IL-2 at 3 Months

Time frame: 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

Time frame: Month 1

Change in Immune system activity

Change from Baseline of Serum levels of IFN-γ at 1st Month

Time frame: Month 3

Change in Immune system activity

Change from Baseline of Serum levels of IFN-γ at 1st Month

Time frame: Month 1

Data from ClinicalTrials.gov

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