Inflammation, Oxidative Stress
Conditions
Keywords
ozonated sunflower oil, antioxidant, inflammation
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.
Interventions
DIETARY_SUPPLEMENTOzonized 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.
Sponsors
S&R Farmaceutici spa
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
Countries
Italy
Outcome results
None listed