Nutritional Clinical Trial to Evaluate the Antioxidant Efficacy of a Product Probiotic in Research
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Oxidative damage to lipids
研究概览
简要总结
Determine the efficacy of the investigational product versus placebo in reducing stress oxidative during the performance of a physical exercise of a certain intensity and duration.
详细描述
The effectiveness of a probiotic for oxidative stress after eight weeks of the product to study will be checked. the sample will be formed by cyclists that will submit to a baseline exercise and after the product is taken.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age: between 18 and 45 years
- •Sex: male, of Caucasian race, selected from the general population.
- •Subjects that perform aerobic physical exercise between 2 and 4 times a week.
- •Volunteers capable of understanding the clinical study, willing to grant consent informed in writing and to comply with the procedures and requirements of the study
排除标准
- •Subjects with a history of any chronic disease.
- •History of bronchial asthma or chronic obstructive pulmonary disease, disease Reactive airways such as bronchial asthma, a history of bronchial asthma or severe chronic obstructive pulmonary disease.
- •Sinus bradycardia, second or third degree of atrioventricular block, insufficiency manifest cardiac or cardiogenic shock.
- •History of allergic hypersensitivity or poor tolerance to any component of the products under study.
- •Participation in another clinical trial in the three months prior to the study Lack of will or inability to comply with clinical trial procedures.
- •Subjects diagnosed and / or under treatment for arterial hypertension.
- •Smoking subjects (> 10 cigarettes a day).
- •Subjects with body mass index greater than 35 Kg / m2 (BMI> 30).
- •Subjects with a history of drug, alcohol or other substance abuse or other factors that limit their ability to cooperate during the study.
- •Subjects whose condition does not make them eligible for the study according to the researcher's criteria.
研究组 & 干预措施
Experimental
One capsule a day will be consumed. At breakfast for the six weeks.
干预措施: Lactobacillus rhamnosus, Lactobacillus casei y Bifidobacterium longum (100MG) (Dietary Supplement)
Experimental
One capsule a day will be consumed. At breakfast for the six weeks.
干预措施: Lactobacillus rhamnosus, Lactobacillus casei y Bifidobacterium longum (300MG) (Dietary Supplement)
Comparator
One capsule a day will be consumed. At breakfast for the six weeks.
干预措施: maltodextrin and sucrose (PLACEBO) (Dietary Supplement)
结局指标
主要结局
Oxidative damage to lipids
时间窗: Oxidative lipid damage will be measured by the ELISA test on two different occasions. The measurements will be made at the beginning and at six weeks of consumption of the product.
It will be measured by isoprostanes in urine 24 hours.
次要结局
- Oxidative damage to DNA(Oxidative damage to DNA will be measured by the ELISA test on two different occasions. The measurements will be made at the beginning and at six weeks of consumption of the product.)
- Oxidative damage to lipids(Oxidative damage to lipids will be measured by the ELISA test on two different occasions. The measurements will be made at the beginning and at six weeks of consumption of the product.)
- Oxidative damage to proteins.(Oxidative damage to protein will be measured by the ELISA test on two different occasions. The measurements will be made at the beginning and at six weeks of consumption of the product.)
- Blood analysis(Blood analysis will be measured by the ELISA test on two different occasions. The measurements will be made at the beginning and at six weeks of consumption of the product.)
研究者
Francisco Javier López Román
Principal Investigator
Universidad Católica San Antonio de Murcia