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

S&R Farmaceutici

Status: Completed

Conditions: Inflammation; Oxidative Stress

Treatments: Dietary Supplement: Ozonized vegetable oil with vitamines

Study type: Interventional

Funder types: Industry

Identifiers

NCT05592509

ANTIOX001

Details and patient eligibility

About

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).

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts 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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups, including a placebo group

Supplement

Active Comparator group

Description:

This arm will take dietary supplement

Treatment:

Dietary Supplement: Ozonized vegetable oil with vitamines

Placebo

Placebo Comparator group

Description:

Placebo will take the placebo

Treatment:

Dietary Supplement: Ozonized vegetable oil with vitamines