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

NCT05592509 | Completed

• 1 other identifier: ANTIOX001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Oxidative Stress; Inflammation

Keywords

ozonated sunflower oil; antioxidant; inflammation

Outcome Measures

Primary Outcomes (16)

• 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 Outcomes (16)

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

  baseline value before crossover

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

  evaluation after 60 days of treatment before crossover

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

  baseline after crossover

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

  evaluation after 60 days of treatment after crossover

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

  baseline value before crossover

Study Arms (2)

Supplement

ACTIVE COMPARATOR

This arm will take dietary supplement

Dietary Supplement: Ozonized vegetable oil with vitamines

Placebo

PLACEBO COMPARATOR

Placebo will take the placebo

Dietary Supplement: Ozonized vegetable oil with vitamines

Interventions

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.

Placebo; Supplement

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• S&R Farmaceutici spa: lead

Study Sites (1)

Crabion srl

Corciano, Perugia, 06073, Italy

Location

Related Publications (22)

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MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Emanuela Floridi, Doctor

  Crabion srl

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: October 24, 2022
• Study Start: September 15, 2022
• Primary Completion: February 15, 2023
• Study Completion: March 24, 2023
• Last Updated: March 27, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)