NCT04912947

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 30, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2021

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 28, 2021

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 3, 2021

Completed
Last Updated

June 4, 2021

Status Verified

June 1, 2021

Enrollment Period

6 months

First QC Date

April 28, 2021

Last Update Submit

June 3, 2021

Conditions

Oxidative Stress

Keywords

Oxidative StressGlutathioneImmune system activityFood supplement

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Change in Immune system activity

    Month 3

  • Change in Immune system activity

    Month 1

  • Change in Immune system activity

    Month 3

  • Change in Immune system activity

    Month 1

Study Arms (2)

Dietary supplement

ACTIVE COMPARATOR

One cp/day of the IMMUSYSTEM food supplement for 3 months

Dietary Supplement: Immusystem

Placebo

PLACEBO COMPARATOR

One cp/day of Placebo for 3 months

Other: Placebo

Interventions

ImmusystemDIETARY_SUPPLEMENT

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

Dietary supplement
PlaceboOTHER

Maltodextrin placebo capsule

Placebo

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Systemic pathologies;
  • Active drug therapy;
  • Estrogen-progestogen therapy;
  • Pregnancy;
  • Allergies to the components of the raw material under study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Calabria

Rende, CS, 87036, Italy

Location

Study Officials

  • Francesco Puoci, PhD

    DFSSN - UNICAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor - DFSSN

Study Record Dates

First Submitted

April 28, 2021

First Posted

June 3, 2021

Study Start

October 30, 2020

Primary Completion

April 15, 2021

Study Completion

April 30, 2021

Last Updated

June 4, 2021

Record last verified: 2021-06

Locations

IT(1)