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NCT Number: NCT02670811

Antihypertensive Effect of Fermented Milk With Lactococcus Lactis on Prehypertensive Subjects

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fermented milk

Dietary Supplement

150 mL daily of fermented milk with Lactococcus lactis NRRL-B50571

Acidified milk

Dietary Supplement

150 mL daily of artificially acidified milk

Primary outcomes

  1. 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

  1. Diastolic Blood Pressure Measurements

    Time frame: Baseline to 10 weeks

    From randomization (baseline), eight weeks of intervention and two weeks post-treatment.

  2. Total Cholesterol Measurements

    Time frame: Baseline and 8th week

    Total cholesterol in baseline and after 8 weeks of treatment (Intake period).

  3. Low Density Lipoproteins Measurements

    Time frame: Baseline and 8th week

    Low density lipoproteins measurements in baseline and after 8 weeks of treatment (intake period).

  4. High Density Lipoproteins

    Time frame: Baseline and 8th week

    High density lipoproteins measurements in baseline and after 8 weeks of treatment (intake period).

  5. Triglycerides Measurements

    Time frame: Baseline and 8th week

    Triglycerides measurements in baseline and after 8 weeks of treatment (intake period).

Sponsors and collaborators

Lead sponsor

Centro de Investigación en Alimentación y Desarrollo A.C.

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 2, 2016
Registry last updated
Oct 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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