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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04912947

Acronym

EVAANIS

Enrollment

Registered

2021-06-03

Start date

2020-10-30

Completion date

2021-04-30

Last updated

2021-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oxidative Stress

Keywords

Oxidative Stress, Glutathione, Immune system activity, Food supplement

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.

Interventions

DIETARY_SUPPLEMENTImmusystem

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

OTHERPlacebo

Maltodextrin placebo capsule

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Change in Erythrocytes GSH/GSSG ratio	Month 3	Change from Baseline reduced/oxidized glutathione ratio in erythrocytes at 3 Months

Secondary

Measure	Time frame	Description
Change in Immune system activity	Month 3	Change from Baseline of Serum levels of immune system activity: TNFα, IL-6, IL-2 at 3 Months

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026