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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
20
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.
Crabion srl
Corciano, Perugia, Italy
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: baseline after crossover
Evaluation of hematic oxidative stress by quantifying ROS (CARR U)
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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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: evaluation after 60 days of treatment after crossover
Assessment of hematic inflammatory parameters by quantifying C-Reactive Protein (CRP)
Evaluation of the modulation of inflammatory parameters by C-Reactive Protein (CRP) using mg/dl as unit of measure
Time frame: baseline value before crossover
Assessment of hematic inflammatory parameters by quantifying C-Reactive Protein (CRP)
Evaluation of the modulation of inflammatory parameters by C-Reactive Protein (CRP) using mg/dl as unit of measure
Time frame: evaluation after 60 days of treatment before crossover
Assessment of hematic inflammatory parameters by quantifying C-Reactive Protein (CRP)
Evaluation of the modulation of inflammatory parameters by C-Reactive Protein (CRP) using mg/dl as unit of measure
Time frame: baseline after crossover
Assessment of hematic inflammatory parameters by quantifying C-Reactive Protein (CRP)
Evaluation of the modulation of inflammatory parameters by C-Reactive Protein (CRP) using mg/dl as unit of measure
Time frame: evaluation after 60 days of treatment after crossover
Assessment of hematic inflammatory parameters by quantifying Erythrocyte Sedimentation Rate (ESR)
Evaluation of the modulation of inflammatory parameters by measuring Erythrocyte Sedimentation Rate (ESR) using mm/h as unit of measure
Time frame: baseline value before crossover
Assessment of hematic inflammatory parameters by quantifying Erythrocyte Sedimentation Rate (ESR)
Evaluation of the modulation of inflammatory parameters by measuring Erythrocyte Sedimentation Rate (ESR) using mm/h as unit of measure
Time frame: evaluation after 60 days of treatment before the crossover
Assessment of hematic inflammatory parameters by quantifying Erythrocyte Sedimentation Rate (ESR)
Evaluation of the modulation of inflammatory parameters by measuring Erythrocyte Sedimentation Rate (ESR) using mm/h as unit of measure
Time frame: baseline after crossover
Assessment of hematic inflammatory parameters by quantifying Erythrocyte Sedimentation Rate (ESR)
Evaluation of the modulation of inflammatory parameters by measuring Erythrocyte Sedimentation Rate (ESR) using mm/h as unit of measure
Time frame: evaluation after 60 days of treatment after crossover
Assessment of hematic inflammatory parameters by quantifying Tumor Necrosis Factor (Tnfα)
Evaluation of the modulation of inflammatory parameters by quantifying Tumor Necrosis Factor (Tnfα) using pg/mL as unit of measure
Time frame: baseline value before crossover
Assessment of hematic inflammatory parameters by quantifying Tumor Necrosis Factor (Tnfα)
Evaluation of the modulation of inflammatory parameters by quantifying Tumor Necrosis Factor (Tnfα) using pg/mL as unit of measure
Time frame: evaluation after 60 days of treatment before crossover
Assessment of hematic inflammatory parameters by quantifying Tumor Necrosis Factor (Tnfα)
Evaluation of the modulation of inflammatory parameters by quantifying Tumor Necrosis Factor (Tnfα) using pg/mL as unit of measure
Time frame: baseline after crossover
Assessment of hematic inflammatory parameters by quantifying Tumor Necrosis Factor (Tnfα)
Evaluation of the modulation of inflammatory parameters by quantifying Tumor Necrosis Factor (Tnfα) using pg/mL as unit of measure
Time frame: evaluation after 60 days of treatment after crossover
Assessment of hematic inflammatory parameters by quantifying Cortisol level
Evaluation of the modulation of inflammatory parameters by measuring Cortisol level using μg/dl as unit of measure
Time frame: baseline value before crossover
Assessment of hematic inflammatory parameters by quantifying Cortisol level
Evaluation of the modulation of inflammatory parameters by measuring Cortisol level using μg/dl as unit of measure
Time frame: evaluation after 60 days of treatment before crossover
Assessment of hematic inflammatory parameters by quantifying Cortisol level
Evaluation of the modulation of inflammatory parameters by measuring Cortisol level using μg/dl as unit of measure
Time frame: baseline value after crossover
Assessment of hematic inflammatory parameters by quantifying Cortisol level
Evaluation of the modulation of inflammatory parameters by measuring Cortisol level using μg/dl as unit of measure
Time frame: evaluation after 60 days of treatment after crossover