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

Oxidative Stress Clinical Trial

— EVAANIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04912947
• Other study ID #: EVAANIS
• Status: Completed
• Phase: N/A
• Start date: October 30, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: June 2021
• Source: Complife Italia Srl
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 30, 2021
• Est. primary completion date: April 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Oxidative Stress

Intervention

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

Other:
• Placebo
Maltodextrin placebo capsule

Locations

Country	Name	City	State
Italy	University of Calabria	Rende	CS

Sponsors (3)

Lead Sponsor	Collaborator
Complife Italia Srl	Icim International Srl, Macrofarm Srl

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Erythrocytes GSH/GSSG ratio	Change from Baseline reduced/oxidized glutathione ratio in erythrocytes at 3 Months	Month 3
Primary	Change in Erythrocytes GSH/GSSG ratio	Change from Baseline reduced/oxidized glutathione ratio in erythrocytes at 1st Month	Month 1
Secondary	Change in Immune system activity	Change from Baseline of Serum levels of immune system activity: TNFa, IL-6, IL-2 at 3 Months	Month 3
Secondary	Change in Immune system activity	Change from Baseline of Serum levels of immune system activity: TNFa, IL-6, IL-2 at 1st Month	Month 1
Secondary	Change in Immune system activity	Change from Baseline of Serum levels of IFN-? at 1st Month	Month 3
Secondary	Change in Immune system activity	Change from Baseline of Serum levels of IFN-? at 1st Month	Month 1