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Antioxidant Effect of Ozonated Vegetable Oil and Vitamins in Moderately Active Subjects (ANTIOX001)

Primary Purpose

Oxidative Stress, Inflammation

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Ozonized vegetable oil with vitamines
Sponsored by
S&R Farmaceutici spa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Oxidative Stress focused on measuring ozonated sunflower oil, antioxidant, inflammation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Crabion srl

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Supplement

Placebo

Arm Description

This arm will take dietary supplement

Placebo will take the placebo

Outcomes

Primary Outcome Measures

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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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

Secondary Outcome Measures

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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Full Information

First Posted
September 27, 2022
Last Updated
March 24, 2023
Sponsor
S&R Farmaceutici spa
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1. Study Identification

Unique Protocol Identification Number
NCT05592509
Brief Title
Antioxidant Effect of Ozonated Vegetable Oil and Vitamins in Moderately Active Subjects
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
September 15, 2022 (Actual)
Primary Completion Date
February 15, 2023 (Actual)
Study Completion Date
March 24, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
S&R Farmaceutici spa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oxidative Stress, Inflammation
Keywords
ozonated sunflower oil, antioxidant, inflammation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supplement
Arm Type
Active Comparator
Arm Description
This arm will take dietary supplement
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo will take the placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Ozonized vegetable oil with vitamines
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluation of hematic oxidative stress by quantifying ROS (CARR U)
Description
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
Time Frame
baseline value before crossover
Title
Evaluation of hematic oxidative stress by quantifying ROS (CARR U)
Description
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
Time Frame
evaluation after 15 days of treatment before crossover
Title
Evaluation of hematic oxidative stress by quantifying ROS (CARR U)
Description
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
Time Frame
evaluation after 30 days of treatment before crossover
Title
Evaluation of hematic oxidative stress by quantifying ROS (CARR U)
Description
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
Time Frame
evaluation after 60 days of treatment before crossover
Title
Evaluation of hematic oxidative stress by quantifying ROS (CARR U)
Description
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
Time Frame
baseline after crossover
Title
Evaluation of hematic oxidative stress by quantifying ROS (CARR U)
Description
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
Time Frame
evaluation after 15 days of treatment after crossover
Title
Evaluation of hematic oxidative stress by quantifying ROS (CARR U)
Description
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
Time Frame
evaluation after 30 days of treatment after crossover
Title
Evaluation of hematic oxidative stress by quantifying ROS (CARR U)
Description
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
Time Frame
evaluation after 60 days of treatment after crossover
Title
Evaluation of hematic oxidative stress by quantifying biological antioxidant potential (umol/l)
Description
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
Time Frame
Baseline before crossover
Title
Evaluation of hematic oxidative stress by biological antioxidant potential (umol/l)
Description
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
Time Frame
evaluation after 15 days of treatment before crossover
Title
Evaluation of hematic oxidative stress by quantifying biological antioxidant potential (umol/l)
Description
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
Time Frame
evaluation after 30 days of treatment before crossover
Title
Evaluation of hematic oxidative stress by quantifying biological antioxidant potential (umol/l)
Description
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
Time Frame
evaluation after 60 days of treatment before crossover
Title
Evaluation of hematic oxidative stress by quantifying biological antioxidant potential (umol/l)
Description
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
Time Frame
baseline after crossover
Title
Evaluation of hematic oxidative stress by quantifying biological antioxidant potential (umol/l)
Description
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
Time Frame
evaluation after 15 days of treatment after crossover
Title
Evaluation of hematic oxidative stress by quantifying biological antioxidant potential (umol/l)
Description
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
Time Frame
evaluation after 30 days of treatment after crossover
Title
Evaluation of hematic oxidative stress by quantifying biological antioxidant potential (umol/l)
Description
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
Time Frame
evaluation after 60 days of treatment after crossover
Secondary Outcome Measure Information:
Title
Assessment of hematic inflammatory parameters by quantifying C-Reactive Protein (CRP)
Description
Evaluation of the modulation of inflammatory parameters by C-Reactive Protein (CRP) using mg/dl as unit of measure
Time Frame
baseline value before crossover
Title
Assessment of hematic inflammatory parameters by quantifying C-Reactive Protein (CRP)
Description
Evaluation of the modulation of inflammatory parameters by C-Reactive Protein (CRP) using mg/dl as unit of measure
Time Frame
evaluation after 60 days of treatment before crossover
Title
Assessment of hematic inflammatory parameters by quantifying C-Reactive Protein (CRP)
Description
Evaluation of the modulation of inflammatory parameters by C-Reactive Protein (CRP) using mg/dl as unit of measure
Time Frame
baseline after crossover
Title
Assessment of hematic inflammatory parameters by quantifying C-Reactive Protein (CRP)
Description
Evaluation of the modulation of inflammatory parameters by C-Reactive Protein (CRP) using mg/dl as unit of measure
Time Frame
evaluation after 60 days of treatment after crossover
Title
Assessment of hematic inflammatory parameters by quantifying Erythrocyte Sedimentation Rate (ESR)
Description
Evaluation of the modulation of inflammatory parameters by measuring Erythrocyte Sedimentation Rate (ESR) using mm/h as unit of measure
Time Frame
baseline value before crossover
Title
Assessment of hematic inflammatory parameters by quantifying Erythrocyte Sedimentation Rate (ESR)
Description
Evaluation of the modulation of inflammatory parameters by measuring Erythrocyte Sedimentation Rate (ESR) using mm/h as unit of measure
Time Frame
evaluation after 60 days of treatment before the crossover
Title
Assessment of hematic inflammatory parameters by quantifying Erythrocyte Sedimentation Rate (ESR)
Description
Evaluation of the modulation of inflammatory parameters by measuring Erythrocyte Sedimentation Rate (ESR) using mm/h as unit of measure
Time Frame
baseline after crossover
Title
Assessment of hematic inflammatory parameters by quantifying Erythrocyte Sedimentation Rate (ESR)
Description
Evaluation of the modulation of inflammatory parameters by measuring Erythrocyte Sedimentation Rate (ESR) using mm/h as unit of measure
Time Frame
evaluation after 60 days of treatment after crossover
Title
Assessment of hematic inflammatory parameters by quantifying Tumor Necrosis Factor (Tnfα)
Description
Evaluation of the modulation of inflammatory parameters by quantifying Tumor Necrosis Factor (Tnfα) using pg/mL as unit of measure
Time Frame
baseline value before crossover
Title
Assessment of hematic inflammatory parameters by quantifying Tumor Necrosis Factor (Tnfα)
Description
Evaluation of the modulation of inflammatory parameters by quantifying Tumor Necrosis Factor (Tnfα) using pg/mL as unit of measure
Time Frame
evaluation after 60 days of treatment before crossover
Title
Assessment of hematic inflammatory parameters by quantifying Tumor Necrosis Factor (Tnfα)
Description
Evaluation of the modulation of inflammatory parameters by quantifying Tumor Necrosis Factor (Tnfα) using pg/mL as unit of measure
Time Frame
baseline after crossover
Title
Assessment of hematic inflammatory parameters by quantifying Tumor Necrosis Factor (Tnfα)
Description
Evaluation of the modulation of inflammatory parameters by quantifying Tumor Necrosis Factor (Tnfα) using pg/mL as unit of measure
Time Frame
evaluation after 60 days of treatment after crossover
Title
Assessment of hematic inflammatory parameters by quantifying Cortisol level
Description
Evaluation of the modulation of inflammatory parameters by measuring Cortisol level using μg/dl as unit of measure
Time Frame
baseline value before crossover
Title
Assessment of hematic inflammatory parameters by quantifying Cortisol level
Description
Evaluation of the modulation of inflammatory parameters by measuring Cortisol level using μg/dl as unit of measure
Time Frame
evaluation after 60 days of treatment before crossover
Title
Assessment of hematic inflammatory parameters by quantifying Cortisol level
Description
Evaluation of the modulation of inflammatory parameters by measuring Cortisol level using μg/dl as unit of measure
Time Frame
baseline value after crossover
Title
Assessment of hematic inflammatory parameters by quantifying Cortisol level
Description
Evaluation of the modulation of inflammatory parameters by measuring Cortisol level using μg/dl as unit of measure
Time Frame
evaluation after 60 days of treatment after crossover

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emanuela Floridi, Doctor
Organizational Affiliation
Crabion srl
Official's Role
Principal Investigator
Facility Information:
Facility Name
Crabion srl
City
Corciano
State/Province
Perugia
ZIP/Postal Code
06073
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
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Antioxidant Effect of Ozonated Vegetable Oil and Vitamins in Moderately Active Subjects

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