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

Sponsor
Complife Italia Srl (Industry)
Overall Status
Completed
CT.gov ID
NCT04912947
Collaborator
Macrofarm Srl (Industry), Icim International Srl (Other)
60
Enrollment
1
Location
2
Arms
6
Actual Duration (Months)
10
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Immusystem
  • Other: Placebo
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
EValuation of the Antioxidant and Anti-inflammatory Capacity of Nutraceutical IMMU·SYSTEM Food Supplement (EVAANIS)
Actual Study Start Date :
Oct 30, 2020
Actual Primary Completion Date :
Apr 15, 2021
Actual Study Completion Date :
Apr 30, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in Erythrocytes GSH/GSSG ratio [Month 3]

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

  2. Change in Erythrocytes GSH/GSSG ratio [Month 1]

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

Secondary Outcome Measures

  1. 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

  2. Change in Immune system activity [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 [Month 3]

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

  4. Change in Immune system activity [Month 1]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 65 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Calabria Rende CS Italy 87036

Sponsors and Collaborators

  • Complife Italia Srl
  • Macrofarm Srl
  • Icim International Srl

Investigators

  • Principal Investigator: Francesco Puoci, PhD, DFSSN - UNICAL

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
FRANCESCO PUOCI, Associate Professor - DFSSN, University of Calabria
ClinicalTrials.gov Identifier:
NCT04912947
Other Study ID Numbers:
  • EVAANIS
First Posted:
Jun 3, 2021
Last Update Posted:
Jun 4, 2021
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by FRANCESCO PUOCI, Associate Professor - DFSSN, University of Calabria
Oxidative Stress
Glutathione
Immune system activity
Food supplement

Study Results

No Results Posted as of Jun 4, 2021