Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Antihypertensive Effect of Fermented Milk With Lactococcus Lactis on Prehypertensive Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02670811
Recruitment Status : Completed
First Posted : February 2, 2016
Results First Posted : October 11, 2016
Last Update Posted : October 18, 2019
Sponsor:
Information provided by (Responsible Party):
Belinda Vallejo Galland, PhD, 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.

Condition or disease Intervention/treatment Phase
Hypertension Dietary Supplement: Fermented milk Dietary Supplement: Acidified milk Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Double-blind Controlled Clinical Study of the Antihypertensive Effect of Fermented Milk With Lactococcus Lactis NRRL-B50571
Study Start Date : August 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
Daily consumption of 150 mL of fermented milk with Lactococcus lactis for 8 weeks
Dietary Supplement: Fermented milk
150 mL daily of fermented milk with Lactococcus lactis NRRL-B50571

Placebo Comparator: Placebo
Daily consumption of 150 mL of artificially acidified milk
Dietary Supplement: Acidified milk
150 mL daily of artificially acidified milk




Primary Outcome Measures :
  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 Outcome Measures :
  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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02670811


Sponsors and Collaborators
Centro de Investigación en Alimentación y Desarrollo A.C.
Investigators
Layout table for investigator information
Principal Investigator: Belinda Vallejo, PhD Centro de Investigación en Alimentación y Desarrollo A.C.
Layout table for additonal information
Responsible Party: Belinda Vallejo Galland, PhD, PhD, Centro de Investigación en Alimentación y Desarrollo A.C.
ClinicalTrials.gov Identifier: NCT02670811    
Other Study ID Numbers: VAGB 001
First Posted: February 2, 2016    Key Record Dates
Results First Posted: October 11, 2016
Last Update Posted: October 18, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Belinda Vallejo Galland, PhD, Centro de Investigación en Alimentación y Desarrollo A.C.:
Hypertension
Fermented Milk
Clinical Study
Randomized
Double-blind
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Vascular Diseases
Cardiovascular Diseases