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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Evaluation of hematic oxidative stress by quantifying biological antioxidant potential (umol/l)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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).
结局指标
主要结局
Evaluation of hematic oxidative stress by quantifying biological antioxidant potential (umol/l)
时间窗: 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
Evaluation of hematic oxidative stress by biological antioxidant potential (umol/l)
时间窗: 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
Evaluation of hematic oxidative stress by quantifying ROS (CARR U)
时间窗: 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
次要结局
- Assessment of hematic inflammatory parameters by quantifying Tumor Necrosis Factor (Tnfα)(evaluation after 60 days of treatment after crossover)
- Assessment of hematic inflammatory parameters by quantifying Erythrocyte Sedimentation Rate (ESR)(evaluation after 60 days of treatment after crossover)
- Assessment of hematic inflammatory parameters by quantifying Cortisol level(evaluation after 60 days of treatment after crossover)
- Assessment of hematic inflammatory parameters by quantifying C-Reactive Protein (CRP)(evaluation after 60 days of treatment after crossover)