Antihypertensive Effect of Fermented Milk With Lactococcus Lactis on Prehypertensive Subjects

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Dietary Supplement: Fermented milk; Dietary Supplement: Acidified milk

• Registration Number: NCT02670811
• Lead Sponsor: Centro de Investigación en Alimentación y Desarrollo A.C.

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 Timeline

• Study Start: 2013-08
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Study First Submitted: 2016-01-26
• Study First Submitted QC: 2016-01-28
• Study First Posted: 2016-02-02
• Results First Submitted: 2016-07-05
• Results First Submitted QC: 2016-08-17
• Results First Posted: 2016-10-11
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-03
• Last Update Posted: 2023-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Fermented milk	Daily consumption of 150 mL of fermented milk with Lactococcus lactis for 8 weeks
Placebo	Acidified milk	Daily consumption of 150 mL of artificially acidified milk

Primary Outcome Measures

Name	Time	Method
Systolic Blood Pressure Measurements	Baseline to 10 weeks	From randomization (baseline), eight weeks of intervention and two weeks after intervention was over.

Secondary Outcome Measures

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