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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supplement | Active Comparator | This arm will take dietary supplement |
|
| Placebo | Placebo Comparator | Placebo will take the placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ozonized vegetable oil with vitamines | Dietary 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Assessment of hematic inflammatory parameters by quantifying C-Reactive Protein (CRP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emanuela Floridi, Doctor | Crabion srl | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Crabion srl | Corciano | Perugia | 06073 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29682215 | Background | 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. | |
| 32380253 | Background | 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. |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
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| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | evaluation after 60 days of treatment after crossover |
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | evaluation after 60 days of treatment after crossover |
| 22175016 | Background | Barbieri 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. |
| 23915064 | Background | 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. |
| 23737208 | Background | 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. |
| 26057750 | Background | 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. |
| 29731617 | Background | 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. |
| 28822266 | Background | 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. |
| Background | Romero 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. |
| 23866833 | Background | 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. |
| 31731503 | Background | Tan 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. |
| 23798923 | Background | Askari 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. |
| 33176827 | Background | 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. |
| 17047219 | Background | 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. |
| 22054960 | Background | 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. |
| 24996369 | Background | 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. |
| 25136602 | Background | Yildirim E, Cinar M, Yalcinkaya I, Ekici H, Atmaca N, Guncum E. Effect of cocoa butter and sunflower oil supplementation on performance, immunoglobulin, and antioxidant vitamin status of rats. Biomed Res Int. 2014;2014:606575. doi: 10.1155/2014/606575. Epub 2014 Jul 16. |
| 34834848 | Background | 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. |
| 10492485 | Background | 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. |
| Background | 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. |
| 21681120 | Background | Ainsworth BE, Haskell WL, Herrmann SD, Meckes N, Bassett DR Jr, Tudor-Locke C, Greer JL, Vezina J, Whitt-Glover MC, Leon AS. 2011 Compendium of Physical Activities: a second update of codes and MET values. Med Sci Sports Exerc. 2011 Aug;43(8):1575-81. doi: 10.1249/MSS.0b013e31821ece12. |
| 11160074 | Result | 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. |