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

Sponsor
S&R Farmaceutici spa (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05592509
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
3.5
Anticipated Duration (Months)
5.6
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Ozonized vegetable oil with vitamines
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention 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.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)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Sep 15, 2022
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Supplement

This arm will take dietary supplement

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.
Placebo Comparator: Placebo

Placebo will take the placebo

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.

Outcome Measures

Primary Outcome Measures

  1. Evaluation of hematic oxidative stress by quantifying ROS (CARR U) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Crabion srl Corciano Perugia Italy 06073

Sponsors and Collaborators

  • S&R Farmaceutici spa

Investigators

  • Principal Investigator: Emanuela Floridi, Doctor, Crabion srl

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
S&R Farmaceutici spa
ClinicalTrials.gov Identifier:
NCT05592509
Other Study ID Numbers:
  • ANTIOX001
First Posted:
Oct 24, 2022
Last Update Posted:
Oct 24, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by S&R Farmaceutici spa
ozonated sunflower oil
antioxidant
inflammation
Additional relevant MeSH terms:
Inflammation
Vitamins

Study Results

No Results Posted as of Oct 24, 2022