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OpenTrials
Completed

NCT Number: NCT04912947

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

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Key information

Conditions

Oxidative Stress

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Calabria

Rende, CS, 87036, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Immusystem

Dietary Supplement

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

Placebo

Other

Maltodextrin placebo capsule

Primary outcomes

  1. Change in Erythrocytes GSH/GSSG ratio

    Time frame: Month 3

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

  2. Change in Erythrocytes GSH/GSSG ratio

    Time frame: Month 1

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

Secondary outcomes

  1. Change in Immune system activity

    Time frame: Month 3

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

  2. Change in Immune system activity

    Time frame: Month 1

    Change from Baseline of Serum levels of immune system activity: TNFα, IL-6, IL-2 at 1st Month

  3. Change in Immune system activity

    Time frame: Month 3

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

  4. Change in Immune system activity

    Time frame: Month 1

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

Sponsors and collaborators

Lead sponsor

Complife Italia Srl

Industry

Collaborators

  • Icim International Srl
  • Macrofarm Srl

Registry information

Acronym: EVAANIS

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 3, 2021
Registry last updated
Jun 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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