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

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 Overview

• Status: Completed
• Conditions: Oxidative Stress
• Intervention / Treatment: Dietary supplement: Immusystem; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • CS
    • Rende, CS, Italy, 87036
      • University of Calabria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Complife Italia Srl
• Collaborators: Macrofarm Srl; Icim International Srl
• Investigators: Principal Investigator: Francesco Puoci, PhD, DFSSN - UNICAL

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2020
• Primary Completion (Actual): April 15, 2021
• Study Completion (Actual): April 30, 2021

Study Registration Dates

• First Submitted: April 28, 2021
• First Submitted That Met QC Criteria: May 31, 2021
• First Posted (Actual): June 3, 2021

Study Record Updates

• Last Update Posted (Actual): June 4, 2021
• Last Update Submitted That Met QC Criteria: June 3, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Oxidative Stress; Food supplement; Glutathione; Immune system activity
• Other Study ID Numbers: EVAANIS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No