Oxidative StressEVAANISNCT04912947
EValuation of the Antioxidant and Anti-inflammatory Capacity of Nutraceutical IMMU·SYSTEM Food Supplement (EVAANIS)
A study testing Immusystem in people with Oxidative Stress, run by Complife Italia Srl at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress
- What is being tested?
- Immusystem
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 30 Oct 2020to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Systemic pathologies;
- Active drug therapy;
- Estrogen-progestogen therapy;
- Pregnancy;
- Allergies to the components of the raw material under study.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Oxidative Stress
- Being tested
- Immusystem, Placebo
- Keywords
- Oxidative Stress, Glutathione, Immune system activity, Food supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmusystemDietary supplement
Dietary supplement containing: Piceid, Glycine, Glutamine, Acetylcysteine, Zinc and Vitamin B6
PlaceboOther
Maltodextrin placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| Dietary supplement | Active comparator | One cp/day of the IMMUSYSTEM food supplement for 3 months Receives: Dietary Supplement: Immusystem |
| Placebo | Placebo comparator | One cp/day of Placebo for 3 months Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Erythrocytes GSH/GSSG ratio
Change from Baseline reduced/oxidized glutathione ratio in erythrocytes at 3 Months
Measured: Month 3
Change in Erythrocytes GSH/GSSG ratio
Change from Baseline reduced/oxidized glutathione ratio in erythrocytes at 1st Month
Measured: Month 1
Secondary outcomes (4)
Change in Immune system activity
Change from Baseline of Serum levels of immune system activity: TNFα, IL-6, IL-2 at 3 Months
Measured: Month 3
Change in Immune system activity
Change from Baseline of Serum levels of immune system activity: TNFα, IL-6, IL-2 at 1st Month
Measured: Month 1
Change in Immune system activity
Change from Baseline of Serum levels of IFN-γ at 1st Month
Measured: Month 3
Change in Immune system activity
Change from Baseline of Serum levels of IFN-γ at 1st Month
Measured: Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start30 Oct 2020
- Primary completion15 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Complife Italia Srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Macrofarm Srl, Icim International Srl
- Responsible party
- Principal investigator, FRANCESCO PUOCI, University of Calabria
- Investigators
- Francesco Puoci, PhD, Principal investigator, DFSSN - UNICAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04912947
- Sponsor's protocol ID
- EVAANIS
- Acronym
- EVAANIS
- Status last verified
- Jun 2021
- First submitted
- 28 Apr 2021
- Last updated
- 4 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EValuation of the Antioxidant and Anti-inflammatory Capacity of Nutraceutical IMMU·SYSTEM Food Supplement (EVAANIS)
- ClinicalTrials.gov ID
- NCT04912947
- Acronym / sponsor ID
- EVAANIS / EVAANIS
- Conditions
- Oxidative Stress
- Keywords
- Oxidative Stress, Glutathione, Immune system activity, Food supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Complife Italia SrlIndustry (pharma, biotech, devices)
- Collaborators
- Macrofarm Srl, Icim International Srl
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 3 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary supplement | Active comparator | Dietary Supplement: ImmusystemOne cp/day of the IMMUSYSTEM food supplement for 3 months |
| Placebo | Placebo comparator | Other: PlaceboOne cp/day of Placebo for 3 months |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- Systemic pathologies;
- Active drug therapy;
- Estrogen-progestogen therapy;
- Pregnancy;
- Allergies to the components of the raw material under study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImmusystemDietary supplement containing: Piceid, Glycine, Glutamine, Acetylcysteine, Zinc and Vitamin B6 | Dietary supplement | Dietary supplement |
| PlaceboMaltodextrin placebo capsule | Other | Placebo |
Primary outcome
Change in Erythrocytes GSH/GSSG ratio
Time frame: Month 3
Change from Baseline reduced/oxidized glutathione ratio in erythrocytes at 3 Months
Change in Erythrocytes GSH/GSSG ratio
Time frame: Month 1
Change from Baseline reduced/oxidized glutathione ratio in erythrocytes at 1st Month
4 secondary outcomes
Change in Immune system activity
Time frame: Month 3
Change in Immune system activity
Time frame: Month 1
Change in Immune system activity
Time frame: Month 3
Change in Immune system activity
Time frame: Month 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Puoci, PhD principal investigator
DFSSN - UNICAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immusystem in people with Oxidative Stress, run by Complife Italia Srl at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Erythrocytes GSH/GSSG ratio (time frame: Month 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2021.