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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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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

Conditions
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Oxidative Stress, Inflammation

Intervention / Treatment
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* Dietary Supplement: Ozonized vegetable oil with vitamines


Participation Criteria
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Eligibility Criteria
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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 (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) 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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Supplement<br>This arm will take dietary supplement | Dietary Supplement: Ozonized vegetable oil with vitamines<br>* 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.<br>|
| Placebo Comparator: Placebo<br>Placebo will take the placebo | Dietary Supplement: Ozonized vegetable oil with vitamines<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ozonated sunflower oil, antioxidant, inflammation