EValuation of the Antioxidant and Anti-inflammatory Capacity of Nutraceutical IMMU·SYSTEM Food Supplement (EVAANIS)
Not Applicable
Completed
- Conditions
- Oxidative Stress
- Interventions
- Other: PlaceboDietary Supplement: Immusystem
- 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
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
- Arm && Interventions
Group Intervention Description Placebo Placebo One cp/day of Placebo for 3 months Dietary supplement Immusystem One cp/day of the IMMUSYSTEM food supplement for 3 months
- 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