Oxidative StressANTIOX001NCT05592509
Antioxidant Effect of Ozonated Vegetable Oil and Vitamins in Moderately Active Subjects
A study testing Ozonized vegetable oil with vitamines in people with Oxidative Stress and Inflammation, run by S&R Farmaceutici S.p.A. at 1 site in Italy.
Trial summary
The purpose of this pilot study is to evaluate the antioxidant effect of a nutraceutical formulation based on vegetable oil and vitamin complex (vitamin K2 and vitamin B9) in subjects with the same level of physical activity (LAF 1.70-1.99, normally active or moderately active). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress, Inflammation
- What is being tested?
- Ozonized vegetable oil with vitamines
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 15 Sep 2022to 24 Mar 2023
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects of both sexes;
- Aged between 18 and 60 years, naïve to taking antioxidant supplements;
- Absent of chronic diseases and current therapies;
- willing and able to understand and sign an informed consent;
- willing to follow a dietary pattern developed according to the LARN (Reference Intake Levels of Nutrients and Energy for the Italian Population) guidelines that establish reference intake levels for Average Energy Requirement (AR) and Macronutrients (Carbohydrates, Lipids and Protein) for the Italian adult population [LARN Tables*];
- Hematobiochemical examinations in normal range: blood count, lipid status, renal and liver function, inflammatory status (Tnfα, C-reactive protein, ESR), glycemic profile (Fasting blood glucose, HbA1C, insulinemia, Homa Index);
- BMI in the normal range (18-24.99);
- Physical activity level LAF 1.70-1.99 (normally active or moderately active)
Who cannot join
- Chronic diseases (chronic renal failure, chronic hepatocellular failure, autoimmune diseases, chronic inflammatory bowel disease, diabetes mellitus, end-stage neoplasms, symptomatic chronic ischemic heart disease)
- Severe hypertension;
- High-grade hypercholesterolemia;
- Age < 18 years;
- Poor compliance;
- Intake of dietary supplements containing antioxidants;
Show all 12Show fewer
- Untreated hypothyroidism;
- Pregnant and lactating women;
- Underweight subjects (BMI ≤18.49);
- Overweight subjects (25≤ BMI ≤30);
- Subjects with obesity (BMI ≥30);
- Subjects with different levels of physical activity: very active (LAF 2.00-2.40) and sedentary (LAF 1.40-1.69).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Antioxidant Effect of a Mixture of Ozonated Vegetable Oil and Vitamin Complex (Vitamin K2 and Vitamin B9) in Moderately Active Subjects With "Physical Activity Level" (LAF: 1.70-1.99): Pilot Study
The purpose of this pilot study is to evaluate the antioxidant effect of a nutraceutical formulation based on vegetable oil and vitamin complex (vitamin K2 and vitamin B9) in subjects with the same level of physical activity (LAF 1.70-1.99, normally active or moderately active).
Read the detailed description
Study design: The pilot study will enroll 20 subjects with physical activity level LAF 1.70-1.99 (normally active or moderately active).
The 20 subjects will be divided into two groups of 10 subjects following randomization. The first group will take the dietary supplement (three capsules per day) for 60 days, while the second group will take a placebo (three capsules per day) for 60 days.
During the treatment period (60 days), the two groups will undergo follow-ups at days 0, 15, 30 and 60 within which clinical and hematochemical examinations will be conducted. At the end of the 60 days, after the wash-out period (two weeks), as per the cross-over design the group previously taking the dietary supplement will be on placebo (three capsules per day) for 60 days, while the group previously taking placebo will take the dietary supplement (three capsules per day) for 60 days. Again, follow-ups will be at 0, 15, 30 and 60 days.
- Conditions
- Oxidative Stress, Inflammation
- Being tested
- Ozonized vegetable oil with vitamines
- Keywords
- ozonated sunflower oil, antioxidant, inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ozonized vegetable oil with vitaminesDietary supplement
description: A single capsule is composed by ozonized vegetable oil (75 mg), vitamin K2 (20 mcg), vitamin B9 (130 mcg). The posology is three capsules/day.
The time of administration is two months.
| Study group | Role | What they receive |
|---|---|---|
| Supplement | Active comparator | This arm will take dietary supplement Receives: Dietary Supplement: Ozonized vegetable oil with vitamines |
| Placebo | Placebo comparator | Placebo will take the placebo Receives: Dietary Supplement: Ozonized vegetable oil with vitamines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of hematic oxidative stress by quantifying ROS (CARR U)
Evaluation of the ability of the dietary supplement to modulate oxidative stress over time by quantifying reactive oxygen metabolites (ROS) using CARR U as units of measure comparing with the placebo-treated group at each follow-up
Measured: baseline value before crossover
Evaluation of hematic oxidative stress by quantifying ROS (CARR U)
Evaluation of the ability of the dietary supplement to modulate oxidative stress over time by quantifying reactive oxygen metabolites (ROS) using CARR U as units of measure comparing with the placebo-treated group at each follow-up
Measured: evaluation after 15 days of treatment before crossover
Evaluation of hematic oxidative stress by quantifying ROS (CARR U)
Evaluation of the ability of the dietary supplement to modulate oxidative stress over time by quantifying reactive oxygen metabolites (ROS) using CARR U as units of measure comparing with the placebo-treated group at each follow-up
Measured: evaluation after 30 days of treatment before crossover
Evaluation of hematic oxidative stress by quantifying ROS (CARR U)
Evaluation of the ability of the dietary supplement to modulate oxidative stress over time by quantifying reactive oxygen metabolites (ROS) using CARR U as units of measure comparing with the placebo-treated group at each follow-up
Measured: evaluation after 60 days of treatment before crossover
Evaluation of hematic oxidative stress by quantifying ROS (CARR U)
Evaluation of the ability of the dietary supplement to modulate oxidative stress over time by quantifying reactive oxygen metabolites (ROS) using CARR U as units of measure comparing with the placebo-treated group at each follow-up
Measured: baseline after crossover
Evaluation of hematic oxidative stress by quantifying ROS (CARR U)
Evaluation of the ability of the dietary supplement to modulate oxidative stress over time by quantifying reactive oxygen metabolites (ROS) using CARR U as units of measure comparing with the placebo-treated group at each follow-up
Measured: evaluation after 15 days of treatment after crossover
Evaluation of hematic oxidative stress by quantifying ROS (CARR U)
Evaluation of the ability of the dietary supplement to modulate oxidative stress over time by quantifying reactive oxygen metabolites (ROS) using CARR U as units of measure comparing with the placebo-treated group at each follow-up
Measured: evaluation after 30 days of treatment after crossover
Evaluation of hematic oxidative stress by quantifying ROS (CARR U)
Evaluation of the ability of the dietary supplement to modulate oxidative stress over time by quantifying reactive oxygen metabolites (ROS) using CARR U as units of measure comparing with the placebo-treated group at each follow-up
Measured: evaluation after 60 days of treatment after crossover
Evaluation of hematic oxidative stress by quantifying biological antioxidant potential (umol/l)
Evaluation of the ability of the dietary supplement to modulate oxidative stress over time by quantifying biological antioxidant potential using umol/l as units of measure comparing with the placebo-treated group at each follow-up
Measured: Baseline before crossover
Evaluation of hematic oxidative stress by biological antioxidant potential (umol/l)
Evaluation of the ability of the dietary supplement to modulate oxidative stress over time by quantifying biological antioxidant potential using umol/l as units of measure comparing with the placebo-treated group at each follow-up
Measured: evaluation after 15 days of treatment before crossover
Evaluation of hematic oxidative stress by quantifying biological antioxidant potential (umol/l)
Evaluation of the ability of the dietary supplement to modulate oxidative stress over time by quantifying biological antioxidant potential using umol/l as units of measure comparing with the placebo-treated group at each follow-up
Measured: evaluation after 30 days of treatment before crossover
Evaluation of hematic oxidative stress by quantifying biological antioxidant potential (umol/l)
Evaluation of the ability of the dietary supplement to modulate oxidative stress over time by quantifying biological antioxidant potential using umol/l as units of measure comparing with the placebo-treated group at each follow-up
Measured: evaluation after 60 days of treatment before crossover
Evaluation of hematic oxidative stress by quantifying biological antioxidant potential (umol/l)
Evaluation of the ability of the dietary supplement to modulate oxidative stress over time by quantifying biological antioxidant potential using umol/l as units of measure comparing with the placebo-treated group at each follow-up
Measured: baseline after crossover
Evaluation of hematic oxidative stress by quantifying biological antioxidant potential (umol/l)
Evaluation of the ability of the dietary supplement to modulate oxidative stress over time by quantifying biological antioxidant potential using umol/l as units of measure comparing with the placebo-treated group at each follow-up
Measured: evaluation after 15 days of treatment after crossover
Evaluation of hematic oxidative stress by quantifying biological antioxidant potential (umol/l)
Evaluation of the ability of the dietary supplement to modulate oxidative stress over time by quantifying biological antioxidant potential using umol/l as units of measure comparing with the placebo-treated group at each follow-up
Measured: evaluation after 30 days of treatment after crossover
Evaluation of hematic oxidative stress by quantifying biological antioxidant potential (umol/l)
Evaluation of the ability of the dietary supplement to modulate oxidative stress over time by quantifying biological antioxidant potential using umol/l as units of measure comparing with the placebo-treated group at each follow-up
Measured: evaluation after 60 days of treatment after crossover
Secondary outcomes (16)
Assessment of hematic inflammatory parameters by quantifying C-Reactive Protein (CRP)
Evaluation of the modulation of inflammatory parameters by C-Reactive Protein (CRP) using mg/dl as unit of measure
Measured: baseline value before crossover
Assessment of hematic inflammatory parameters by quantifying C-Reactive Protein (CRP)
Evaluation of the modulation of inflammatory parameters by C-Reactive Protein (CRP) using mg/dl as unit of measure
Measured: evaluation after 60 days of treatment before crossover
Assessment of hematic inflammatory parameters by quantifying C-Reactive Protein (CRP)
Evaluation of the modulation of inflammatory parameters by C-Reactive Protein (CRP) using mg/dl as unit of measure
Measured: baseline after crossover
Assessment of hematic inflammatory parameters by quantifying C-Reactive Protein (CRP)
Evaluation of the modulation of inflammatory parameters by C-Reactive Protein (CRP) using mg/dl as unit of measure
Measured: evaluation after 60 days of treatment after crossover
Assessment of hematic inflammatory parameters by quantifying Erythrocyte Sedimentation Rate (ESR)
Evaluation of the modulation of inflammatory parameters by measuring Erythrocyte Sedimentation Rate (ESR) using mm/h as unit of measure
Measured: baseline value before crossover
Assessment of hematic inflammatory parameters by quantifying Erythrocyte Sedimentation Rate (ESR)
Evaluation of the modulation of inflammatory parameters by measuring Erythrocyte Sedimentation Rate (ESR) using mm/h as unit of measure
Measured: evaluation after 60 days of treatment before the crossover
Assessment of hematic inflammatory parameters by quantifying Erythrocyte Sedimentation Rate (ESR)
Evaluation of the modulation of inflammatory parameters by measuring Erythrocyte Sedimentation Rate (ESR) using mm/h as unit of measure
Measured: baseline after crossover
Assessment of hematic inflammatory parameters by quantifying Erythrocyte Sedimentation Rate (ESR)
Evaluation of the modulation of inflammatory parameters by measuring Erythrocyte Sedimentation Rate (ESR) using mm/h as unit of measure
Measured: evaluation after 60 days of treatment after crossover
Assessment of hematic inflammatory parameters by quantifying Tumor Necrosis Factor (Tnfα)
Evaluation of the modulation of inflammatory parameters by quantifying Tumor Necrosis Factor (Tnfα) using pg/mL as unit of measure
Measured: baseline value before crossover
Assessment of hematic inflammatory parameters by quantifying Tumor Necrosis Factor (Tnfα)
Evaluation of the modulation of inflammatory parameters by quantifying Tumor Necrosis Factor (Tnfα) using pg/mL as unit of measure
Measured: evaluation after 60 days of treatment before crossover
Assessment of hematic inflammatory parameters by quantifying Tumor Necrosis Factor (Tnfα)
Evaluation of the modulation of inflammatory parameters by quantifying Tumor Necrosis Factor (Tnfα) using pg/mL as unit of measure
Measured: baseline after crossover
Assessment of hematic inflammatory parameters by quantifying Tumor Necrosis Factor (Tnfα)
Evaluation of the modulation of inflammatory parameters by quantifying Tumor Necrosis Factor (Tnfα) using pg/mL as unit of measure
Measured: evaluation after 60 days of treatment after crossover
Assessment of hematic inflammatory parameters by quantifying Cortisol level
Evaluation of the modulation of inflammatory parameters by measuring Cortisol level using μg/dl as unit of measure
Measured: baseline value before crossover
Assessment of hematic inflammatory parameters by quantifying Cortisol level
Evaluation of the modulation of inflammatory parameters by measuring Cortisol level using μg/dl as unit of measure
Measured: evaluation after 60 days of treatment before crossover
Assessment of hematic inflammatory parameters by quantifying Cortisol level
Evaluation of the modulation of inflammatory parameters by measuring Cortisol level using μg/dl as unit of measure
Measured: baseline value after crossover
Assessment of hematic inflammatory parameters by quantifying Cortisol level
Evaluation of the modulation of inflammatory parameters by measuring Cortisol level using μg/dl as unit of measure
Measured: evaluation after 60 days of treatment after crossover
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start15 Sep 2022
- Primary completion15 Feb 2023
- Study completion24 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- 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
- Crossover
- Model description
- Twenty subjects will be divided into two groups of 10 subjects following randomization. The first group will take the dietary supplement (three capsules per day) for 60 days, while the second group will take a placebo (three capsules per day) for 60 days. During the treatment period (60 days), the two groups will undergo follow-ups at days 0, 15, 30 and 60 within which clinical and hematochemical examinations will be conducted as per Table 2. At the end of the 60 days, after the wash-out period (two weeks), as per the cross-over design the group previously taking the dietary supplement will be on placebo (three capsules per day) for 60 days, while the group previously taking placebo will take the dietary supplement (three capsules per day) for 60 days. Again, follow-ups will be at 0, 15, 30 and 60 days.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- S&R Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emanuela Floridi, Doctor, Principal investigator, Crabion srl
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05592509
- Sponsor's protocol ID
- ANTIOX001
- Acronym
- ANTIOX001
- Status last verified
- Oct 2022
- First submitted
- 27 Sep 2022
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Simioni C, Zauli G, Martelli AM, Vitale M, Sacchetti G, Gonelli A, Neri LM. Oxidative stress: role of physical exercise and antioxidant nutraceuticals in adulthood and aging. Oncotarget. 2018 Mar 30;9(24):17181-17198. doi: 10.18632/oncotarget.24729. eCollection 2018 Mar 30.
PubMed 29682215Powers SK, Deminice R, Ozdemir M, Yoshihara T, Bomkamp MP, Hyatt H. Exercise-induced oxidative stress: Friend or foe? J Sport Health Sci. 2020 Sep;9(5):415-425. doi: 10.1016/j.jshs.2020.04.001. Epub 2020 May 4.
PubMed 32380253Barbieri E, Sestili P. Reactive oxygen species in skeletal muscle signaling. J Signal Transduct. 2012;2012:982794. doi: 10.1155/2012/982794. Epub 2011 Dec 5.
PubMed 22175016Sakellariou GK, Jackson MJ, Vasilaki A. Redefining the major contributors to superoxide production in contracting skeletal muscle. The role of NAD(P)H oxidases. Free Radic Res. 2014 Jan;48(1):12-29. doi: 10.3109/10715762.2013.830718. Epub 2013 Oct 7.
PubMed 23915064Powers SK, Ji LL, Kavazis AN, Jackson MJ. Reactive oxygen species: impact on skeletal muscle. Compr Physiol. 2011 Apr;1(2):941-69. doi: 10.1002/cphy.c100054.
PubMed 23737208Orsavova J, Misurcova L, Ambrozova JV, Vicha R, Mlcek J. Fatty Acids Composition of Vegetable Oils and Its Contribution to Dietary Energy Intake and Dependence of Cardiovascular Mortality on Dietary Intake of Fatty Acids. Int J Mol Sci. 2015 Jun 5;16(6):12871-90. doi: 10.3390/ijms160612871.
PubMed 26057750Liguori I, Russo G, Curcio F, Bulli G, Aran L, Della-Morte D, Gargiulo G, Testa G, Cacciatore F, Bonaduce D, Abete P. Oxidative stress, aging, and diseases. Clin Interv Aging. 2018 Apr 26;13:757-772. doi: 10.2147/CIA.S158513. eCollection 2018.
PubMed 29731617Mironczuk-Chodakowska I, Witkowska AM, Zujko ME. Endogenous non-enzymatic antioxidants in the human body. Adv Med Sci. 2018 Mar;63(1):68-78. doi: 10.1016/j.advms.2017.05.005. Epub 2017 Aug 17.
PubMed 28822266Romero AC. et al. 2013, 'The Exogenous Antioxidants', in J. A. Morales-González (ed.), oxidative Stress and Chronic Degenerative Diseases - A Role for Antioxidants, IntechOpen, London. doi: 10.5772/52490.
Romeu M, Aranda N, Giralt M, Ribot B, Nogues MR, Arija V. Diet, iron biomarkers and oxidative stress in a representative sample of Mediterranean population. Nutr J. 2013 Jul 16;12:102. doi: 10.1186/1475-2891-12-102.
PubMed 23866833Tan BL, Norhaizan ME. Effect of High-Fat Diets on Oxidative Stress, Cellular Inflammatory Response and Cognitive Function. Nutrients. 2019 Oct 25;11(11):2579. doi: 10.3390/nu11112579.
PubMed 31731503Askari G, Ghiasvand R, Feizi A, Ghanadian SM, Karimian J. The effect of quercetin supplementation on selected markers of inflammation and oxidative stress. J Res Med Sci. 2012 Jul;17(7):637-41.
PubMed 23798923Buonocore D, Verri M, Giolitto A, Doria E, Ghitti M, Dossena M. Effect of 8-week n-3 fatty-acid supplementation on oxidative stress and inflammation in middle- and long-distance running athletes: a pilot study. J Int Soc Sports Nutr. 2020 Nov 11;17(1):55. doi: 10.1186/s12970-020-00391-4.
PubMed 33176827Mozaffarian D, Rimm EB. Fish intake, contaminants, and human health: evaluating the risks and the benefits. JAMA. 2006 Oct 18;296(15):1885-99. doi: 10.1001/jama.296.15.1885.
PubMed 17047219Misurcova L, Ambrozova J, Samek D. Seaweed lipids as nutraceuticals. Adv Food Nutr Res. 2011;64:339-55. doi: 10.1016/B978-0-12-387669-0.00027-2.
PubMed 22054960
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Antioxidant Effect of a Mixture of Ozonated Vegetable Oil and Vitamin Complex (Vitamin K2 and Vitamin B9) in Moderately Active Subjects With "Physical Activity Level" (LAF: 1.70-1.99): Pilot Study
- ClinicalTrials.gov ID
- NCT05592509
- Acronym / sponsor ID
- ANTIOX001 / ANTIOX001
- Conditions
- Oxidative Stress, Inflammation
- Keywords
- ozonated sunflower oil, antioxidant, inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- S&R Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 24 Mar 2023 (actual)
- First posted
- 24 Oct 2022 (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 purpose of this pilot study is to evaluate the antioxidant effect of a nutraceutical formulation based on vegetable oil and vitamin complex (vitamin K2 and vitamin B9) in subjects with the same level of physical activity (LAF 1.70-1.99, normally active or moderately active).
Detailed description
Study design: The pilot study will enroll 20 subjects with physical activity level LAF 1.70-1.99 (normally active or moderately active).
The 20 subjects will be divided into two groups of 10 subjects following randomization. The first group will take the dietary supplement (three capsules per day) for 60 days, while the second group will take a placebo (three capsules per day) for 60 days.
During the treatment period (60 days), the two groups will undergo follow-ups at days 0, 15, 30 and 60 within which clinical and hematochemical examinations will be conducted. At the end of the 60 days, after the wash-out period (two weeks), as per the cross-over design the group previously taking the dietary supplement will be on placebo (three capsules per day) for 60 days, while the group previously taking placebo will take the dietary supplement (three capsules per day) for 60 days. Again, follow-ups will be at 0, 15, 30 and 60 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Twenty subjects will be divided into two groups of 10 subjects following randomization. The first group will take the dietary supplement (three capsules per day) for 60 days, while the second group will take a placebo (three capsules per day) for 60 days. During the treatment period (60 days), the two groups will undergo follow-ups at days 0, 15, 30 and 60 within which clinical and hematochemical examinations will be conducted as per Table 2. At the end of the 60 days, after the wash-out period (two weeks), as per the cross-over design the group previously taking the dietary supplement will be on placebo (three capsules per day) for 60 days, while the group previously taking placebo will take the dietary supplement (three capsules per day) for 60 days. Again, follow-ups will be at 0, 15, 30 and 60 days.
| Arm | Type | Receives |
|---|---|---|
| Supplement | Active comparator | Dietary Supplement: Ozonized vegetable oil with vitaminesThis arm will take dietary supplement |
| Placebo | Placebo comparator | Dietary Supplement: Ozonized vegetable oil with vitaminesPlacebo will take the placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subjects of both sexes;
- Aged between 18 and 60 years, naïve to taking antioxidant supplements;
- Absent of chronic diseases and current therapies;
- willing and able to understand and sign an informed consent;
- willing to follow a dietary pattern developed according to the LARN (Reference Intake Levels of Nutrients and Energy for the Italian Population) guidelines that establish reference intake levels for Average Energy Requirement (AR) and Macronutrients (Carbohydrates, Lipids and Protein) for the Italian adult population [LARN Tables*];
Key exclusion criteria (12 listed)
- Chronic diseases (chronic renal failure, chronic hepatocellular failure, autoimmune diseases, chronic inflammatory bowel disease, diabetes mellitus, end-stage neoplasms, symptomatic chronic ischemic heart disease)
- Severe hypertension;
- High-grade hypercholesterolemia;
- Age < 18 years;
- Poor compliance;
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 |
|---|---|---|
| Ozonized vegetable oil with vitaminesdescription: A single capsule is composed by ozonized vegetable oil (75 mg), vitamin K2 (20 mcg), vitamin B9 (130 mcg). The posology is three capsules/day. The time of administration is two months. | Dietary supplement | Placebo, Supplement |
Primary outcome
Evaluation of hematic oxidative stress by quantifying ROS (CARR U)
Time frame: baseline value before crossover
Evaluation of the ability of the dietary supplement to modulate oxidative stress over time by quantifying reactive oxygen metabolites (ROS) using CARR U as units of measure comparing with the placebo-treated group at each follow-up
Evaluation of hematic oxidative stress by quantifying ROS (CARR U)
Time frame: evaluation after 15 days of treatment before crossover
Evaluation of the ability of the dietary supplement to modulate oxidative stress over time by quantifying reactive oxygen metabolites (ROS) using CARR U as units of measure comparing with the placebo-treated group at each follow-up
Evaluation of hematic oxidative stress by quantifying ROS (CARR U)
Time frame: evaluation after 30 days of treatment before crossover
Evaluation of the ability of the dietary supplement to modulate oxidative stress over time by quantifying reactive oxygen metabolites (ROS) using CARR U as units of measure comparing with the placebo-treated group at each follow-up
Evaluation of hematic oxidative stress by quantifying ROS (CARR U)
Time frame: evaluation after 60 days of treatment before crossover
Evaluation of the ability of the dietary supplement to modulate oxidative stress over time by quantifying reactive oxygen metabolites (ROS) using CARR U as units of measure comparing with the placebo-treated group at each follow-up
Evaluation of hematic oxidative stress by quantifying ROS (CARR U)
Time frame: baseline after crossover
Evaluation of the ability of the dietary supplement to modulate oxidative stress over time by quantifying reactive oxygen metabolites (ROS) using CARR U as units of measure comparing with the placebo-treated group at each follow-up
Evaluation of hematic oxidative stress by quantifying ROS (CARR U)
Time frame: evaluation after 15 days of treatment after crossover
Evaluation of the ability of the dietary supplement to modulate oxidative stress over time by quantifying reactive oxygen metabolites (ROS) using CARR U as units of measure comparing with the placebo-treated group at each follow-up
Evaluation of hematic oxidative stress by quantifying ROS (CARR U)
Time frame: evaluation after 30 days of treatment after crossover
Evaluation of the ability of the dietary supplement to modulate oxidative stress over time by quantifying reactive oxygen metabolites (ROS) using CARR U as units of measure comparing with the placebo-treated group at each follow-up
Evaluation of hematic oxidative stress by quantifying ROS (CARR U)
Time frame: evaluation after 60 days of treatment after crossover
Evaluation of the ability of the dietary supplement to modulate oxidative stress over time by quantifying reactive oxygen metabolites (ROS) using CARR U as units of measure comparing with the placebo-treated group at each follow-up
Evaluation of hematic oxidative stress by quantifying biological antioxidant potential (umol/l)
Time frame: Baseline before crossover
Evaluation of the ability of the dietary supplement to modulate oxidative stress over time by quantifying biological antioxidant potential using umol/l as units of measure comparing with the placebo-treated group at each follow-up
Evaluation of hematic oxidative stress by biological antioxidant potential (umol/l)
Time frame: evaluation after 15 days of treatment before crossover
Evaluation of the ability of the dietary supplement to modulate oxidative stress over time by quantifying biological antioxidant potential using umol/l as units of measure comparing with the placebo-treated group at each follow-up
Evaluation of hematic oxidative stress by quantifying biological antioxidant potential (umol/l)
Time frame: evaluation after 30 days of treatment before crossover
Evaluation of the ability of the dietary supplement to modulate oxidative stress over time by quantifying biological antioxidant potential using umol/l as units of measure comparing with the placebo-treated group at each follow-up
Evaluation of hematic oxidative stress by quantifying biological antioxidant potential (umol/l)
Time frame: evaluation after 60 days of treatment before crossover
Evaluation of the ability of the dietary supplement to modulate oxidative stress over time by quantifying biological antioxidant potential using umol/l as units of measure comparing with the placebo-treated group at each follow-up
Evaluation of hematic oxidative stress by quantifying biological antioxidant potential (umol/l)
Time frame: baseline after crossover
Evaluation of the ability of the dietary supplement to modulate oxidative stress over time by quantifying biological antioxidant potential using umol/l as units of measure comparing with the placebo-treated group at each follow-up
Evaluation of hematic oxidative stress by quantifying biological antioxidant potential (umol/l)
Time frame: evaluation after 15 days of treatment after crossover
Evaluation of the ability of the dietary supplement to modulate oxidative stress over time by quantifying biological antioxidant potential using umol/l as units of measure comparing with the placebo-treated group at each follow-up
Evaluation of hematic oxidative stress by quantifying biological antioxidant potential (umol/l)
Time frame: evaluation after 30 days of treatment after crossover
Evaluation of the ability of the dietary supplement to modulate oxidative stress over time by quantifying biological antioxidant potential using umol/l as units of measure comparing with the placebo-treated group at each follow-up
Evaluation of hematic oxidative stress by quantifying biological antioxidant potential (umol/l)
Time frame: evaluation after 60 days of treatment after crossover
Evaluation of the ability of the dietary supplement to modulate oxidative stress over time by quantifying biological antioxidant potential using umol/l as units of measure comparing with the placebo-treated group at each follow-up
16 secondary outcomes
Assessment of hematic inflammatory parameters by quantifying C-Reactive Protein (CRP)
Time frame: baseline value before crossover
Assessment of hematic inflammatory parameters by quantifying C-Reactive Protein (CRP)
Time frame: evaluation after 60 days of treatment before crossover
Assessment of hematic inflammatory parameters by quantifying C-Reactive Protein (CRP)
Time frame: baseline after crossover
Assessment of hematic inflammatory parameters by quantifying C-Reactive Protein (CRP)
Time frame: evaluation after 60 days of treatment after crossover
Assessment of hematic inflammatory parameters by quantifying Erythrocyte Sedimentation Rate (ESR)
Time frame: baseline value before crossover
Assessment of hematic inflammatory parameters by quantifying Erythrocyte Sedimentation Rate (ESR)
Time frame: evaluation after 60 days of treatment before the crossover
Assessment of hematic inflammatory parameters by quantifying Erythrocyte Sedimentation Rate (ESR)
Time frame: baseline after crossover
Assessment of hematic inflammatory parameters by quantifying Erythrocyte Sedimentation Rate (ESR)
Time frame: evaluation after 60 days of treatment after crossover
Assessment of hematic inflammatory parameters by quantifying Tumor Necrosis Factor (Tnfα)
Time frame: baseline value before crossover
Assessment of hematic inflammatory parameters by quantifying Tumor Necrosis Factor (Tnfα)
Time frame: evaluation after 60 days of treatment before crossover
Assessment of hematic inflammatory parameters by quantifying Tumor Necrosis Factor (Tnfα)
Time frame: baseline after crossover
Assessment of hematic inflammatory parameters by quantifying Tumor Necrosis Factor (Tnfα)
Time frame: evaluation after 60 days of treatment after crossover
Assessment of hematic inflammatory parameters by quantifying Cortisol level
Time frame: baseline value before crossover
Assessment of hematic inflammatory parameters by quantifying Cortisol level
Time frame: evaluation after 60 days of treatment before crossover
Assessment of hematic inflammatory parameters by quantifying Cortisol level
Time frame: baseline value after crossover
Assessment of hematic inflammatory parameters by quantifying Cortisol level
Time frame: evaluation after 60 days of treatment after crossover
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 27 Mar 2023.
- Background: PubMed 29682215Simioni C, Zauli G, Martelli AM, Vitale M, Sacchetti G, Gonelli A, Neri LM. Oxidative stress: role of physical exercise and antioxidant nutraceuticals in adulthood and aging. Oncotarget. 2018 Mar 30;9(24):17181-17198. doi: 10.18632/oncotarget.24729. eCollection 2018 Mar 30.
- Background: PubMed 32380253Powers SK, Deminice R, Ozdemir M, Yoshihara T, Bomkamp MP, Hyatt H. Exercise-induced oxidative stress: Friend or foe? J Sport Health Sci. 2020 Sep;9(5):415-425. doi: 10.1016/j.jshs.2020.04.001. Epub 2020 May 4.
- Background: PubMed 22175016Barbieri E, Sestili P. Reactive oxygen species in skeletal muscle signaling. J Signal Transduct. 2012;2012:982794. doi: 10.1155/2012/982794. Epub 2011 Dec 5.
- Background: PubMed 23915064Sakellariou GK, Jackson MJ, Vasilaki A. Redefining the major contributors to superoxide production in contracting skeletal muscle. The role of NAD(P)H oxidases. Free Radic Res. 2014 Jan;48(1):12-29. doi: 10.3109/10715762.2013.830718. Epub 2013 Oct 7.
- Background: PubMed 23737208Powers SK, Ji LL, Kavazis AN, Jackson MJ. Reactive oxygen species: impact on skeletal muscle. Compr Physiol. 2011 Apr;1(2):941-69. doi: 10.1002/cphy.c100054.
- Background: PubMed 26057750Orsavova J, Misurcova L, Ambrozova JV, Vicha R, Mlcek J. Fatty Acids Composition of Vegetable Oils and Its Contribution to Dietary Energy Intake and Dependence of Cardiovascular Mortality on Dietary Intake of Fatty Acids. Int J Mol Sci. 2015 Jun 5;16(6):12871-90. doi: 10.3390/ijms160612871.
- Background: PubMed 29731617Liguori I, Russo G, Curcio F, Bulli G, Aran L, Della-Morte D, Gargiulo G, Testa G, Cacciatore F, Bonaduce D, Abete P. Oxidative stress, aging, and diseases. Clin Interv Aging. 2018 Apr 26;13:757-772. doi: 10.2147/CIA.S158513. eCollection 2018.
- Background: PubMed 28822266Mironczuk-Chodakowska I, Witkowska AM, Zujko ME. Endogenous non-enzymatic antioxidants in the human body. Adv Med Sci. 2018 Mar;63(1):68-78. doi: 10.1016/j.advms.2017.05.005. Epub 2017 Aug 17.
- BackgroundRomero AC. et al. 2013, 'The Exogenous Antioxidants', in J. A. Morales-González (ed.), oxidative Stress and Chronic Degenerative Diseases - A Role for Antioxidants, IntechOpen, London. doi: 10.5772/52490.
- Background: PubMed 23866833Romeu M, Aranda N, Giralt M, Ribot B, Nogues MR, Arija V. Diet, iron biomarkers and oxidative stress in a representative sample of Mediterranean population. Nutr J. 2013 Jul 16;12:102. doi: 10.1186/1475-2891-12-102.
- Background: PubMed 31731503Tan BL, Norhaizan ME. Effect of High-Fat Diets on Oxidative Stress, Cellular Inflammatory Response and Cognitive Function. Nutrients. 2019 Oct 25;11(11):2579. doi: 10.3390/nu11112579.
- Background: PubMed 23798923Askari G, Ghiasvand R, Feizi A, Ghanadian SM, Karimian J. The effect of quercetin supplementation on selected markers of inflammation and oxidative stress. J Res Med Sci. 2012 Jul;17(7):637-41.
- Individual participant dataSharing planned: No
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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.
Emanuela Floridi, Doctor principal investigator
Crabion srl
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ozonized vegetable oil with vitamines in people with Oxidative Stress and Inflammation, run by S&R Farmaceutici S.p.A. 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 8 inclusion and 12 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 27 Mar 2023. 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?
Evaluation of hematic oxidative stress by quantifying ROS (CARR U) (time frame: baseline value before crossover). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05592509, which also lists 22 linked publications.
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 27 Mar 2023.