CClinicalTrials.gg
Sign In
CompletedNCT02670811Updated Oct 12, 2023Results posted

Antihypertensive Effect of Fermented Milk With Lactococcus Lactis on Prehypertensive Subjects

An interventional study of Fermented milk and Acidified milk in Hypertension, sponsored by Centro de Investigación en Alimentación y Desarrollo A.C.. Completed. Open to participants aged 25 Years to 55 Years. Per ClinicalTrials.gov, last updated 2023-10-12.

Sponsored by Centro de Investigación en Alimentación y Desarrollo A.C. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
25 Years to 55 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hypertension

Browse trials for

Keywords

  • Hypertension
  • Fermented Milk
  • Clinical Study
  • Randomized
  • Double-blind
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 36 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Centro de Investigación en Alimentación y Desarrollo A.C. is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Systolic blood pressure >130 mmHg
  • Diastolic blood pressure > 85 mmHg

Exclusion criteria

Exclusion Criteria:

  • Pregnant women
  • Cardiovascular diseases
  • Diabetes
  • Cancer
  • Dairy allergy
  • Lactose intolerance
  • Patients receiving angiotensin converting enzyme inhibitors as pharmacological therapy
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    Intervention

    Daily consumption of 150 mL of fermented milk with Lactococcus lactis for 8 weeks

    Dietary Supplement: Fermented milk

  • Placebo comparator
    Placebo

    Daily consumption of 150 mL of artificially acidified milk

    Dietary Supplement: Acidified milk

Interventions

  • Dietary supplementFermented milk

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

  • Dietary supplementAcidified milk

    150 mL daily of artificially acidified milk

06

What researchers measure

Primary outcomes

  1. Systolic Blood Pressure Measurements

    From randomization (baseline), eight weeks of intervention and two weeks after intervention was over.

    Time frame: Baseline to 10 weeks

Secondary outcomes

  1. Diastolic Blood Pressure Measurements

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

    Time frame: Baseline to 10 weeks

  2. Total Cholesterol Measurements

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

    Time frame: Baseline and 8th week

  3. Low Density Lipoproteins Measurements

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

    Time frame: Baseline and 8th week

  4. High Density Lipoproteins

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

    Time frame: Baseline and 8th week

  5. Triglycerides Measurements

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

    Time frame: Baseline and 8th week

07

Results

Posted Oct 11, 2016

Participant flow

Participant flow — Overall Study
MilestoneInterventionPlacebo
Started1818
Completed1718
Not completed10

Outcome measures

PrimarySystolic Blood Pressure Measurements

From randomization (baseline), eight weeks of intervention and two weeks after intervention was over.

Time frame:
Baseline to 10 weeks
Reported as:
Mean · mmHg
Systolic Blood Pressure Measurements
mmHgInterventionPlacebo
Baseline131.8 ± 5.7134.3 ± 7
Week 1 Intake Period122.1 ± 13.6127.4 ± 11.3
Week 2 Intake Period121.3 ± 9.6125.8 ± 10.3
Week 3 Intake Period120 ± 11.4127.1 ± 8.3
Week 4 Intake Period121.1 ± 14.2125 ± 8.5
Week 5 Intake Period116.6 ± 12.3124.8 ± 11
Week 6 Intake Period120.4 ± 11.6126.4 ± 10.5
Week 7 Intake Period118.9 ± 12.6125.6 ± 10
Week 8 Intake Period122.5 ± 8.3127.6 ± 8.9
Week 1 Post-Treatment122.3 ± 12.9127.3 ± 9.6
Week 2 Post-Treatment124 ± 12.6128 ± 10.2
Statistical analysis
  • Intervention vs Placebo · t-test, 2 sided · p = <0.05 (The primary outcome, systolic blood pressure (mmHg), between groups was analyzed using an independent sample student t test.)
  • Intervention · t-test, 2 sided · p = <0.05 (The primary outcome, systolic blood pressure (mmHg), was analyzed using a paired student t test.)
SecondaryDiastolic Blood Pressure Measurements

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

Time frame:
Baseline to 10 weeks
Reported as:
Mean · mmHg
Diastolic Blood Pressure Measurements
mmHgInterventionPlacebo
Baseline87.7 ± 5.189.4 ± 5.7
Week 1 Intake Period82.3 ± 9.585.9 ± 7.6
Week 2 Intake Period80.8 ± 884.2 ± 5.9
Week 3 Intake Period81.9 ± 885.7 ± 7.9
Week 4 Intake Period80.4 ± 10.784.4 ± 6.7
Week 5 Intake Period80.7 ± 9.184.5 ± 8.5
Week 6 Intake Period82.6 ± 9.684.1 ± 7.8
Week 7 Intake Period80.7 ± 11.184.9 ± 7
Week 8 Intake Period83.7 ± 5.986.4 ± 5
Week 1 Post-Treatment84.3 ± 9.387.1 ± 6.3
Week 2 Post-Treatment84.7 ± 9.186.3 ± 6.2
Statistical analysis
  • Intervention vs Placebo · t-test, 2 sided · p = <0.05 (The secondary outcome, diastolic blood pressure (mmHg), between groups was analyzed using an independent sample student t test.)
SecondaryTotal Cholesterol Measurements

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

Time frame:
Baseline and 8th week
Reported as:
Mean · mg/dL
Total Cholesterol Measurements
mg/dLInterventionPlacebo
Baseline190.1 ± 43.6178.1 ± 26
Week 8 Intake Period180.7 ± 36.1189.8 ± 39.1
Statistical analysis
  • Intervention vs Placebo · t-test, 2 sided · p = <0.05 (The secondary outcome, total cholesterol (mg/dL), between groups was analyzed using an independent sample student t test.)
SecondaryLow Density Lipoproteins Measurements

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

Time frame:
Baseline and 8th week
Reported as:
Mean · mg/dL
Low Density Lipoproteins Measurements
mg/dLInterventionPlacebo
Baseline127.1 ± 43114.7 ± 26
Week 8 Intake Period116.6 ± 37.8122.7 ± 31.8
Statistical analysis
  • Intervention vs Placebo · t-test, 2 sided · p = <0.05 (The secondary outcome, low density lipoprotein (mg/dL), between groups was analyzed using an independent sample student t test.)
SecondaryHigh Density Lipoproteins

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

Time frame:
Baseline and 8th week
Reported as:
Mean · mg/dL
High Density Lipoproteins
mg/dLInterventionPlacebo
Baseline37.9 ± 8.737.8 ± 6.5
Week 8 Intake Period43.2 ± 8.142.4 ± 7.6
Statistical analysis
  • Intervention vs Placebo · t-test, 2 sided · p = <0.05 (The secondary outcome, high density lipoproteins (mg/dL), between groups were analyzed using an independent sample student t test.)
SecondaryTriglycerides Measurements

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

Time frame:
Baseline and 8th week
Reported as:
Mean · mg/dL
Triglycerides Measurements
mg/dLInterventionPlacebo
Baseline137.5 ± 42.3144.3 ± 63.5
Week 8 Intake Period103.6 ± 44.3124.9 ± 56
Statistical analysis
  • Intervention vs Placebo · t-test, 2 sided · p = <0.05 (The secondary outcome, triglycerides (mg/dL), between groups was analyzed using an independent sample student t test.)

Adverse events

Collected over 12 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Intervention—0/18 (0%)0/18 (0%)
Placebo—0/18 (0%)0/18 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(Years)InterventionPlaceboTotal
Mean40.5 ± 11.744.6 ± 9.242.5 ± 10.5
Sex: Female, Male
Sex: Female, Male(Participants)InterventionPlaceboTotal
Female8816
Male101020
Region of Enrollment
Region of Enrollment(Participants)InterventionPlaceboTotal
Mexico181836
Systolic blood pressure
Systolic blood pressure(mmHg)InterventionPlaceboTotal
Mean131.8 ± 5.6134.3 ± 7133.1 ± 6.4
Diastolic blood pressure
Diastolic blood pressure(mmHg)InterventionPlaceboTotal
Mean87.7 ± 5.189.3 ± 5.888.6 ± 5.4
Weight
Weight(kilograms)InterventionPlaceboTotal
Mean80.5 ± 14.685.8 ± 18.283.2 ± 16.5
Height
Height(meters)InterventionPlaceboTotal
Mean1.63 ± 0.11.67 ± 0.11.65 ± 0.1
Total cholesterol
Total cholesterol(mg/dL)InterventionPlaceboTotal
Mean190.1 ± 43.6178.1 ± 26184.1 ± 35.9

3 further baseline measures are reported on the registry.

08

Study locations

No study locations are listed for this record.

09

References and documents

Individual participant data

Plan to share: Yes — Individual participant data for study protocol, statistical analysis plan, clinical study report and analytic code may be shared upon request.

Supporting information: Study protocol, Sap, Csr, Analytic code

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02670811
Lead sponsor
Centro de Investigación en Alimentación y Desarrollo A.C.
Responsible party
Belinda Vallejo Galland, PhD (PhD, Centro de Investigación en Alimentación y Desarrollo A.C.) — Principal investigator
First posted
Feb 2, 2016
Start date
Aug 2013
Primary completion
Dec 2013
Completion
Dec 2013
Results posted
Oct 11, 2016
Last update
Oct 12, 2023

Study contacts

Belinda Vallejo, PhD
principal investigator · Centro de Investigación en Alimentación y Desarrollo A.C.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hypertension→

Other studies from this sponsor

Centro de Investigación en Alimentación y Desarrollo A.C.

Start the discussion