Antioxidant Effect of Ozonated Vegetable Oil and Vitamins in Moderately Active Subjects

Inflammation Clinical Trial

— ANTIOX001  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05592509
• Other study ID #: ANTIOX001
• Status: Completed
• Phase: N/A
• Start date: September 15, 2022
• Est. completion date: March 24, 2023

Study information

• Verified date: October 2022
• Source: S&R Farmaceutici spa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 24, 2023
• Est. primary completion date: February 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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 (Tnfa, 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)

Exclusion Criteria:

• 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;

• 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).

Related Conditions & MeSH terms

• Inflammation
• Oxidative Stress

Intervention

Dietary Supplement:
• Ozonized vegetable oil with vitamines
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.

Locations

Country	Name	City	State
Italy	Crabion srl	Corciano	Perugia

Sponsors (1)

Lead Sponsor	Collaborator
S&R Farmaceutici spa

Country where clinical trial is conducted

Italy, 

References & Publications (22)

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Buonocore 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. — View Citation

Dhavamani S, Poorna Chandra Rao Y, Lokesh BR. Total antioxidant activity of selected vegetable oils and their influence on total antioxidant values in vivo: a photochemiluminescence based analysis. Food Chem. 2014 Dec 1;164:551-5. doi: 10.1016/j.foodchem.2014.05.064. Epub 2014 May 22. — View Citation

El-Hamidi M. Zaher FA. Production of vegetable oils in the world and in Egypt: An overview. Bull Natl Res Cent. 2018, 42, 1-9. doi: 10.1186/s42269-018-0019-0.

Kim JG, Yousef AE, Dave S. Application of ozone for enhancing the microbiological safety and quality of foods: a review. J Food Prot. 1999 Sep;62(9):1071-87. doi: 10.4315/0362-028x-62.9.1071. — View Citation

Liguori 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. — View Citation

Mironczuk-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. — View Citation

Misurcova 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. — View Citation

Mozaffarian 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. Erratum In: JAMA. 2007 Feb 14;297(6):590. — View Citation

Orsavova 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. — View Citation

Petraru A, Ursachi F, Amariei S. Nutritional Characteristics Assessment of Sunflower Seeds, Oil and Cake. Perspective of Using Sunflower Oilcakes as a Functional Ingredient. Plants (Basel). 2021 Nov 17;10(11):2487. doi: 10.3390/plants10112487. — View Citation

Powers 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. — View Citation

Powers 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. — View Citation

Reid MB. Invited Review: redox modulation of skeletal muscle contraction: what we know and what we don't. J Appl Physiol (1985). 2001 Feb;90(2):724-31. doi: 10.1152/jappl.2001.90.2.724. — View Citation

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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. — View Citation

Sakellariou 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. — View Citation

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* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	baseline value before crossover
Primary	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	evaluation after 15 days of treatment before crossover
Primary	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	evaluation after 30 days of treatment before crossover
Primary	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	evaluation after 60 days of treatment before crossover
Primary	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	baseline after crossover
Primary	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	evaluation after 15 days of treatment after crossover
Primary	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	evaluation after 30 days of treatment after crossover
Primary	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	evaluation after 60 days of treatment after crossover
Primary	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	Baseline before crossover
Primary	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	evaluation after 15 days of treatment before crossover
Primary	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	evaluation after 30 days of treatment before crossover
Primary	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	evaluation after 60 days of treatment before crossover
Primary	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	baseline after crossover
Primary	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	evaluation after 15 days of treatment after crossover
Primary	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	evaluation after 30 days of treatment after crossover
Primary	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	evaluation after 60 days of treatment after crossover
Secondary	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	baseline value before crossover
Secondary	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	evaluation after 60 days of treatment before crossover
Secondary	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	baseline after crossover
Secondary	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	evaluation after 60 days of treatment after crossover
Secondary	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	baseline value before crossover
Secondary	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	evaluation after 60 days of treatment before the crossover
Secondary	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	baseline after crossover
Secondary	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	evaluation after 60 days of treatment after crossover
Secondary	Assessment of hematic inflammatory parameters by quantifying Tumor Necrosis Factor (Tnfa)	Evaluation of the modulation of inflammatory parameters by quantifying Tumor Necrosis Factor (Tnfa) using pg/mL as unit of measure	baseline value before crossover
Secondary	Assessment of hematic inflammatory parameters by quantifying Tumor Necrosis Factor (Tnfa)	Evaluation of the modulation of inflammatory parameters by quantifying Tumor Necrosis Factor (Tnfa) using pg/mL as unit of measure	evaluation after 60 days of treatment before crossover
Secondary	Assessment of hematic inflammatory parameters by quantifying Tumor Necrosis Factor (Tnfa)	Evaluation of the modulation of inflammatory parameters by quantifying Tumor Necrosis Factor (Tnfa) using pg/mL as unit of measure	baseline after crossover
Secondary	Assessment of hematic inflammatory parameters by quantifying Tumor Necrosis Factor (Tnfa)	Evaluation of the modulation of inflammatory parameters by quantifying Tumor Necrosis Factor (Tnfa) using pg/mL as unit of measure	evaluation after 60 days of treatment after crossover
Secondary	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	baseline value before crossover
Secondary	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	evaluation after 60 days of treatment before crossover
Secondary	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	baseline value after crossover
Secondary	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	evaluation after 60 days of treatment after crossover