Randomized Double-blind Controlled Clinical Study of the Antihypertensive Effect of Fermented Milk With Lactococcus Lactis NRRL-B50571
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 36
- Primary Endpoint
- Systolic Blood Pressure Measurements
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 25 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Systolic blood pressure >130 mmHg
- •Diastolic blood pressure > 85 mmHg
Exclusion Criteria
- •Pregnant women
- •Cardiovascular diseases
- •Dairy allergy
- •Lactose intolerance
- •Patients receiving angiotensin converting enzyme inhibitors as pharmacological therapy
Outcomes
Primary Outcomes
Systolic Blood Pressure Measurements
Time Frame: Baseline to 10 weeks
From randomization (baseline), eight weeks of intervention and two weeks after intervention was over.
Secondary Outcomes
- 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)
Investigators
Belinda Vallejo Galland, PhD
PhD
Centro de Investigación en Alimentación y Desarrollo A.C.