Effect of the Administration of the Intracellular Content Obtained From Lactobacillus Casei CRL-431 on the Antioxidant Capacity of Breast Milk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Antioxidant activity oxygen radical absorption capacity
研究概览
简要总结
The objective of the present study was to evaluate the effect of the consumption of the intracellular content of Lactobacillus casei CRL-431 on the antioxidant capacity of breast milk
详细描述
A double blind randomized controlled clinical study of an 30-d intervention with 16 nursing mothers was carried out to evaluate the effect of the consumption of the intracellular content of Lactobacillus casei CRL-431 on the antioxidant capacity of breast milk. Once obtained the informed consent; volunteers were ramdomized into two groups (n=8) to either receive 5 mL daily: edible gel with intracellular content of Lb. casei CRL-431 (intervention group) or edible gel without intracellular content of Lb. casei CRL-431 as control (placebo). Both gels were consumed daily. Participants were asked not to change their diet or lifestyle during the intervention. We applied intention to treat for those participants who did not have good adherence and those who withdraw the study. The outcomes between groups were analyzed using a independent samples student t-test, with P value of 0.05 or less (two sided) when there was a statistical differences. Non-parametric data were analyzed with Mann-Whitney test; using statistical software.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Nursing mothers between 3 and 52 weeks of lactation
排除标准
- •Clinical evidence of chronic disease or gastrointestinal disorders
- •Structural defects in the breast (breast surgery, mammary gland hypoplasia, among others)
- •Cancer and/or radiotherapy
- •Consumption of: antioxidant supplements, probiotics, symbiotics and/or antibiotics in the month prior to recruitment.
- •Alcohol or drugs consumption
结局指标
主要结局
Antioxidant activity oxygen radical absorption capacity
时间窗: Change from baseline antioxidant activity oxygen radical absorption capacity at day 30
Antioxidant activity by oxygen radical absorption capacity technique in breast milk
Trolox equivalent antioxidant capacity
时间窗: Change from baseline Trolox equivalent antioxidant capacity at day 30
Determination of Trolox equivalent antioxidant capacity in breast milk
Trolox equivalent Antioxidant capacity
时间窗: Change from baseline Trolox equivalent antioxidant capacity at day 15
Determination of Trolox equivalent antioxidant capacity in breast milk
次要结局
- Superoxide dismutase enzyme activity(Change from baseline superoxide dismutase enzyme activity at day 15)
- Glutation peroxidase enzyme activity(Change from baseline glutation peroxidase enzyme activity at day 15)
- Vitamin C(Change from baseline Vitamin C at day 15)
- Catalase enzyme activity(Change from baseline catalase enzyme activity at day 15)
- Glutathione activity(Change from baseline glutathione activity at day 15)
- Malondialdehyde(Change from baseline malondialdehyde at day 15)
- Hydrogen peroxide(Change from baseline hydrogen peroxide at day 15)
- Oxidative stress index(Change from baseline oxidative stress index at day 15)
研究者
Adrian Hernandez Mendoza
Principal Investigator
Centro de Investigación en Alimentación y Desarrollo A.C.