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

Not Applicable

Completed

• Conditions: Oxidative Stress

• Registration Number: NCT04912947
• Lead Sponsor: Complife Italia Srl

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-30
• Primary Completion: 2021-04-15
• Study First Submitted: 2021-04-28
• Study Completion: 2021-04-30
• Study First Submitted QC: 2021-05-31
• Status Verified: 2021-06
• Study First Posted: 2021-06-03
• Last Update Submitted: 2021-06-03
• Last Update Posted: 2021-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Erythrocytes GSH/GSSG ratio	Month 1	Change from Baseline reduced/oxidized glutathione ratio in erythrocytes at 1st Month

Secondary Outcome Measures

Name	Time	Method
Change in Immune system activity	Month 1	Change from Baseline of Serum levels of IFN-γ at 1st Month

Trial Locations

Locations (1)

University of Calabria; 🇮🇹 Rende, CS, Italy