Antihypertensive Effect of Fermented Milk With Lactococcus Lactis on Prehypertensive Subjects

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Double-blind Controlled Clinical Study of the Antihypertensive Effect of Fermented Milk With Lactococcus Lactis NRRL-B50571

Conditions
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Hypertension

Intervention / Treatment
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* Dietary Supplement: Fermented milk
* Dietary Supplement: Acidified milk


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Systolic blood pressure >130 mmHg Diastolic blood pressure > 85 mmHg Exclusion Criteria: Pregnant women Cardiovascular diseases Diabetes Cancer Dairy allergy Lactose intolerance Patients receiving angiotensin converting enzyme inhibitors as pharmacological therapy

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Daily consumption of 150 mL of fermented milk with Lactococcus lactis for 8 weeks | Dietary Supplement: Fermented milk<br>* 150 mL daily of fermented milk with Lactococcus lactis NRRL-B50571<br>|
| Placebo Comparator: Placebo<br>Daily consumption of 150 mL of artificially acidified milk | Dietary Supplement: Acidified milk<br>* 150 mL daily of artificially acidified milk<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic Blood Pressure Measurements | From randomization (baseline), eight weeks of intervention and two weeks after intervention was over. | Baseline to 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diastolic Blood Pressure Measurements | From randomization (baseline), eight weeks of intervention and two weeks post-treatment. | Baseline to 10 weeks | 
| Total Cholesterol Measurements | Total cholesterol in baseline and after 8 weeks of treatment (Intake period). | Baseline and 8th week | 
| Low Density Lipoproteins Measurements | Low density lipoproteins measurements in baseline and after 8 weeks of treatment (intake period). | Baseline and 8th week | 
| High Density Lipoproteins | High density lipoproteins measurements in baseline and after 8 weeks of treatment (intake period). | Baseline and 8th week | 
| Triglycerides Measurements | Triglycerides measurements in baseline and after 8 weeks of treatment (intake period). | Baseline and 8th week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Fermented Milk, Clinical Study, Randomized, Double-blind