Randomized Double-blind Controlled Clinical Study of the Antihypertensive Effect of Fermented Milk With Lactococcus Lactis NRRL-B50571
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 主要终点
- Systolic Blood Pressure Measurements
研究概览
简要总结
The objective of the present work was to evaluate the antihypertensive effect associated with the consumption of fermented milk with Lactococcus lactis NRRL-B50571 on prehypertensive subjects.
详细描述
A double-blind randomized controlled clinical study of an 8-week intervention with 36 hypertensive subjects was carried out to evaluate the antihypertensive effect of fermented milk with Lactococcus lactis NRRL-B50571. Once obtained the informed consent; volunteers were randomized into two groups (n=18) to either receive 150 mL daily: fermented milk with Lactococcus lactis NRRL-B50571 (intervention group) or artificially acidified milk as control (placebo). Both drinks 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 an independent sample Student t test, with a P value of 0.05 or less (two sided) when there was statistical significance; 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
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Systolic blood pressure >130 mmHg
- •Diastolic blood pressure > 85 mmHg
排除标准
- •Pregnant women
- •Cardiovascular diseases
- •Dairy allergy
- •Lactose intolerance
- •Patients receiving angiotensin converting enzyme inhibitors as pharmacological therapy
结局指标
主要结局
Systolic Blood Pressure Measurements
时间窗: Baseline to 10 weeks
From randomization (baseline), eight weeks of intervention and two weeks after intervention was over.
次要结局
- Total Cholesterol Measurements(Baseline and 8th week)
- High Density Lipoproteins(Baseline and 8th week)
- Low Density Lipoproteins Measurements(Baseline and 8th week)
- Triglycerides Measurements(Baseline and 8th week)
- Diastolic Blood Pressure Measurements(Baseline to 10 weeks)
研究者
Belinda Vallejo Galland, PhD
PhD
Centro de Investigación en Alimentación y Desarrollo A.C.