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Completed

NCT Number: NCT05592509

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

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).

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Key information

Conditions

Oxidative Stress Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Crabion srl

Corciano, Perugia, 06073, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

Secondary outcomes

  1. Assessment of hematic inflammatory parameters by quantifying C-Reactive Protein (CRP)

    Time frame: baseline value before crossover

    Evaluation of the modulation of inflammatory parameters by C-Reactive Protein (CRP) using mg/dl as unit of measure

  2. Assessment of hematic inflammatory parameters by quantifying C-Reactive Protein (CRP)

    Time frame: evaluation after 60 days of treatment before crossover

    Evaluation of the modulation of inflammatory parameters by C-Reactive Protein (CRP) using mg/dl as unit of measure

  3. Assessment of hematic inflammatory parameters by quantifying C-Reactive Protein (CRP)

    Time frame: baseline after crossover

    Evaluation of the modulation of inflammatory parameters by C-Reactive Protein (CRP) using mg/dl as unit of measure

  4. Assessment of hematic inflammatory parameters by quantifying C-Reactive Protein (CRP)

    Time frame: 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

  5. Assessment of hematic inflammatory parameters by quantifying Erythrocyte Sedimentation Rate (ESR)

    Time frame: baseline value before crossover

    Evaluation of the modulation of inflammatory parameters by measuring Erythrocyte Sedimentation Rate (ESR) using mm/h as unit of measure

  6. Assessment of hematic inflammatory parameters by quantifying Erythrocyte Sedimentation Rate (ESR)

    Time frame: evaluation after 60 days of treatment before the crossover

    Evaluation of the modulation of inflammatory parameters by measuring Erythrocyte Sedimentation Rate (ESR) using mm/h as unit of measure

  7. Assessment of hematic inflammatory parameters by quantifying Erythrocyte Sedimentation Rate (ESR)

    Time frame: baseline after crossover

    Evaluation of the modulation of inflammatory parameters by measuring Erythrocyte Sedimentation Rate (ESR) using mm/h as unit of measure

  8. Assessment of hematic inflammatory parameters by quantifying Erythrocyte Sedimentation Rate (ESR)

    Time frame: evaluation after 60 days of treatment after crossover

    Evaluation of the modulation of inflammatory parameters by measuring Erythrocyte Sedimentation Rate (ESR) using mm/h as unit of measure

  9. Assessment of hematic inflammatory parameters by quantifying Tumor Necrosis Factor (Tnfα)

    Time frame: baseline value before crossover

    Evaluation of the modulation of inflammatory parameters by quantifying Tumor Necrosis Factor (Tnfα) using pg/mL as unit of measure

  10. Assessment of hematic inflammatory parameters by quantifying Tumor Necrosis Factor (Tnfα)

    Time frame: evaluation after 60 days of treatment before crossover

    Evaluation of the modulation of inflammatory parameters by quantifying Tumor Necrosis Factor (Tnfα) using pg/mL as unit of measure

  11. Assessment of hematic inflammatory parameters by quantifying Tumor Necrosis Factor (Tnfα)

    Time frame: baseline after crossover

    Evaluation of the modulation of inflammatory parameters by quantifying Tumor Necrosis Factor (Tnfα) using pg/mL as unit of measure

  12. Assessment of hematic inflammatory parameters by quantifying Tumor Necrosis Factor (Tnfα)

    Time frame: evaluation after 60 days of treatment after crossover

    Evaluation of the modulation of inflammatory parameters by quantifying Tumor Necrosis Factor (Tnfα) using pg/mL as unit of measure

  13. Assessment of hematic inflammatory parameters by quantifying Cortisol level

    Time frame: baseline value before crossover

    Evaluation of the modulation of inflammatory parameters by measuring Cortisol level using μg/dl as unit of measure

  14. Assessment of hematic inflammatory parameters by quantifying Cortisol level

    Time frame: evaluation after 60 days of treatment before crossover

    Evaluation of the modulation of inflammatory parameters by measuring Cortisol level using μg/dl as unit of measure

  15. Assessment of hematic inflammatory parameters by quantifying Cortisol level

    Time frame: baseline value after crossover

    Evaluation of the modulation of inflammatory parameters by measuring Cortisol level using μg/dl as unit of measure

  16. Assessment of hematic inflammatory parameters by quantifying Cortisol level

    Time frame: evaluation after 60 days of treatment after crossover

    Evaluation of the modulation of inflammatory parameters by measuring Cortisol level using μg/dl as unit of measure

Sponsors and collaborators

Lead sponsor

S&R Farmaceutici S.p.A.

Industry

Registry information

Official study 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

Acronym: ANTIOX001

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 24, 2022
Registry last updated
Mar 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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