Hypertension
Conditions
Keywords
Hypertension, Fermented Milk, Clinical Study, Randomized, Double-blind
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.
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
Sponsors
Centro de Investigación en Alimentación y Desarrollo A.C.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood Pressure Measurements | Baseline to 10 weeks | From randomization (baseline), eight weeks of intervention and two weeks after intervention was over. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diastolic Blood Pressure Measurements | Baseline to 10 weeks | From randomization (baseline), eight weeks of intervention and two weeks post-treatment. |
| Total Cholesterol Measurements | Baseline and 8th week | Total cholesterol 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). |
| High Density Lipoproteins | Baseline and 8th week | High 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). |
Participant flow
Pre-assignment details
Participants who were eligible were asked to sign informed consents. Afterwards all baseline measurements were taken two weeks before randomization and group formations. Subjects who did not fulfill the inclusion criteria were explained why they were not eligible for this study.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Daily consumption of 150 mL of fermented milk with Lactococcus lactis for 8 weeks
Fermented milk: 150 mL daily of fermented milk with Lactococcus lactis NRRL-B50571 | 18 |
| Placebo Daily consumption of 150 mL of artificially acidified milk
Acidified milk: 150 mL daily of artificially acidified milk | 18 |
| Total | 36 |
Baseline characteristics
| Characteristic | Intervention | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 40.5 Years STANDARD_DEVIATION 11.7 | 44.6 Years STANDARD_DEVIATION 9.2 | 42.5 Years STANDARD_DEVIATION 10.5 |
| Diastolic blood pressure | 87.7 mmHg STANDARD_DEVIATION 5.1 | 89.3 mmHg STANDARD_DEVIATION 5.8 | 88.6 mmHg STANDARD_DEVIATION 5.4 |
| Height | 1.63 meters STANDARD_DEVIATION 0.1 | 1.67 meters STANDARD_DEVIATION 0.1 | 1.65 meters STANDARD_DEVIATION 0.1 |
| High density lipoprotein | 37.9 mg/dL STANDARD_DEVIATION 8.7 | 37.8 mg/dL STANDARD_DEVIATION 6.5 | 37.9 mg/dL STANDARD_DEVIATION 7.6 |
| Low density lipoprotein | 127.1 mg/dL STANDARD_DEVIATION 43 | 114.7 mg/dL STANDARD_DEVIATION 26 | 120.9 mg/dL STANDARD_DEVIATION 35.5 |
| Region of Enrollment Mexico | 18 Participants | 18 Participants | 36 Participants |
| Sex: Female, Male Female | 8 Participants | 8 Participants | 16 Participants |
| Sex: Female, Male Male | 10 Participants | 10 Participants | 20 Participants |
| Systolic blood pressure | 131.8 mmHg STANDARD_DEVIATION 5.6 | 134.3 mmHg STANDARD_DEVIATION 7 | 133.1 mmHg STANDARD_DEVIATION 6.4 |
| Total cholesterol | 190.1 mg/dL STANDARD_DEVIATION 43.6 | 178.1 mg/dL STANDARD_DEVIATION 26 | 184.1 mg/dL STANDARD_DEVIATION 35.9 |
| Triglycerides | 137.5 mg/dL STANDARD_DEVIATION 42.3 | 144.3 mg/dL STANDARD_DEVIATION 63.5 | 141 mg/dL STANDARD_DEVIATION 53.3 |
| Weight | 80.5 kilograms STANDARD_DEVIATION 14.6 | 85.8 kilograms STANDARD_DEVIATION 18.2 | 83.2 kilograms STANDARD_DEVIATION 16.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 18 | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 |
Outcome results
Primary
Systolic Blood Pressure Measurements
From randomization (baseline), eight weeks of intervention and two weeks after intervention was over.
Time frame: Baseline to 10 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Systolic Blood Pressure Measurements | Week 3 Intake Period | 120 mmHg | Standard Deviation 11.4 |
| Intervention | Systolic Blood Pressure Measurements | Week 6 Intake Period | 120.4 mmHg | Standard Deviation 11.6 |
| Intervention | Systolic Blood Pressure Measurements | Week 2 Intake Period | 121.3 mmHg | Standard Deviation 9.6 |
| Intervention | Systolic Blood Pressure Measurements | Week 7 Intake Period | 118.9 mmHg | Standard Deviation 12.6 |
| Intervention | Systolic Blood Pressure Measurements | Week 4 Intake Period | 121.1 mmHg | Standard Deviation 14.2 |
| Intervention | Systolic Blood Pressure Measurements | Week 8 Intake Period | 122.5 mmHg | Standard Deviation 8.3 |
| Intervention | Systolic Blood Pressure Measurements | Week 1 Intake Period | 122.1 mmHg | Standard Deviation 13.6 |
| Intervention | Systolic Blood Pressure Measurements | Week 1 Post-Treatment | 122.3 mmHg | Standard Deviation 12.9 |
| Intervention | Systolic Blood Pressure Measurements | Week 5 Intake Period | 116.6 mmHg | Standard Deviation 12.3 |
| Intervention | Systolic Blood Pressure Measurements | Week 2 Post-Treatment | 124 mmHg | Standard Deviation 12.6 |
| Intervention | Systolic Blood Pressure Measurements | Baseline | 131.8 mmHg | Standard Deviation 5.7 |
| Placebo | Systolic Blood Pressure Measurements | Week 2 Post-Treatment | 128 mmHg | Standard Deviation 10.2 |
| Placebo | Systolic Blood Pressure Measurements | Baseline | 134.3 mmHg | Standard Deviation 7 |
| Placebo | Systolic Blood Pressure Measurements | Week 1 Intake Period | 127.4 mmHg | Standard Deviation 11.3 |
| Placebo | Systolic Blood Pressure Measurements | Week 2 Intake Period | 125.8 mmHg | Standard Deviation 10.3 |
| Placebo | Systolic Blood Pressure Measurements | Week 3 Intake Period | 127.1 mmHg | Standard Deviation 8.3 |
| Placebo | Systolic Blood Pressure Measurements | Week 4 Intake Period | 125 mmHg | Standard Deviation 8.5 |
| Placebo | Systolic Blood Pressure Measurements | Week 5 Intake Period | 124.8 mmHg | Standard Deviation 11 |
| Placebo | Systolic Blood Pressure Measurements | Week 6 Intake Period | 126.4 mmHg | Standard Deviation 10.5 |
| Placebo | Systolic Blood Pressure Measurements | Week 7 Intake Period | 125.6 mmHg | Standard Deviation 10 |
| Placebo | Systolic Blood Pressure Measurements | Week 8 Intake Period | 127.6 mmHg | Standard Deviation 8.9 |
| Placebo | Systolic Blood Pressure Measurements | Week 1 Post-Treatment | 127.3 mmHg | Standard Deviation 9.6 |
p-value: <0.05t-test, 2 sided
p-value: <0.05t-test, 2 sided
Secondary
Diastolic Blood Pressure Measurements
From randomization (baseline), eight weeks of intervention and two weeks post-treatment.
Time frame: Baseline to 10 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Diastolic Blood Pressure Measurements | Week 6 Intake Period | 82.6 mmHg | Standard Deviation 9.6 |
| Intervention | Diastolic Blood Pressure Measurements | Week 1 Post-Treatment | 84.3 mmHg | Standard Deviation 9.3 |
| Intervention | Diastolic Blood Pressure Measurements | Week 5 Intake Period | 80.7 mmHg | Standard Deviation 9.1 |
| Intervention | Diastolic Blood Pressure Measurements | Week 2 Post-Treatment | 84.7 mmHg | Standard Deviation 9.1 |
| Intervention | Diastolic Blood Pressure Measurements | Week 7 Intake Period | 80.7 mmHg | Standard Deviation 11.1 |
| Intervention | Diastolic Blood Pressure Measurements | Baseline | 87.7 mmHg | Standard Deviation 5.1 |
| Intervention | Diastolic Blood Pressure Measurements | Week 4 Intake Period | 80.4 mmHg | Standard Deviation 10.7 |
| Intervention | Diastolic Blood Pressure Measurements | Week 1 Intake Period | 82.3 mmHg | Standard Deviation 9.5 |
| Intervention | Diastolic Blood Pressure Measurements | Week 8 Intake Period | 83.7 mmHg | Standard Deviation 5.9 |
| Intervention | Diastolic Blood Pressure Measurements | Week 2 Intake Period | 80.8 mmHg | Standard Deviation 8 |
| Intervention | Diastolic Blood Pressure Measurements | Week 3 Intake Period | 81.9 mmHg | Standard Deviation 8 |
| Placebo | Diastolic Blood Pressure Measurements | Week 2 Intake Period | 84.2 mmHg | Standard Deviation 5.9 |
| Placebo | Diastolic Blood Pressure Measurements | Week 3 Intake Period | 85.7 mmHg | Standard Deviation 7.9 |
| Placebo | Diastolic Blood Pressure Measurements | Week 4 Intake Period | 84.4 mmHg | Standard Deviation 6.7 |
| Placebo | Diastolic Blood Pressure Measurements | Week 5 Intake Period | 84.5 mmHg | Standard Deviation 8.5 |
| Placebo | Diastolic Blood Pressure Measurements | Week 6 Intake Period | 84.1 mmHg | Standard Deviation 7.8 |
| Placebo | Diastolic Blood Pressure Measurements | Week 7 Intake Period | 84.9 mmHg | Standard Deviation 7 |
| Placebo | Diastolic Blood Pressure Measurements | Week 8 Intake Period | 86.4 mmHg | Standard Deviation 5 |
| Placebo | Diastolic Blood Pressure Measurements | Week 1 Post-Treatment | 87.1 mmHg | Standard Deviation 6.3 |
| Placebo | Diastolic Blood Pressure Measurements | Week 2 Post-Treatment | 86.3 mmHg | Standard Deviation 6.2 |
| Placebo | Diastolic Blood Pressure Measurements | Baseline | 89.4 mmHg | Standard Deviation 5.7 |
| Placebo | Diastolic Blood Pressure Measurements | Week 1 Intake Period | 85.9 mmHg | Standard Deviation 7.6 |
p-value: <0.05t-test, 2 sided
Secondary
High Density Lipoproteins
High density lipoproteins measurements in baseline and after 8 weeks of treatment (intake period).
Time frame: Baseline and 8th week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | High Density Lipoproteins | Baseline | 37.9 mg/dL | Standard Deviation 8.7 |
| Intervention | High Density Lipoproteins | Week 8 Intake Period | 43.2 mg/dL | Standard Deviation 8.1 |
| Placebo | High Density Lipoproteins | Baseline | 37.8 mg/dL | Standard Deviation 6.5 |
| Placebo | High Density Lipoproteins | Week 8 Intake Period | 42.4 mg/dL | Standard Deviation 7.6 |
p-value: <0.05t-test, 2 sided
Secondary
Low Density Lipoproteins Measurements
Low density lipoproteins measurements in baseline and after 8 weeks of treatment (intake period).
Time frame: Baseline and 8th week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Low Density Lipoproteins Measurements | Baseline | 127.1 mg/dL | Standard Deviation 43 |
| Intervention | Low Density Lipoproteins Measurements | Week 8 Intake Period | 116.6 mg/dL | Standard Deviation 37.8 |
| Placebo | Low Density Lipoproteins Measurements | Baseline | 114.7 mg/dL | Standard Deviation 26 |
| Placebo | Low Density Lipoproteins Measurements | Week 8 Intake Period | 122.7 mg/dL | Standard Deviation 31.8 |
p-value: <0.05t-test, 2 sided
Secondary
Total Cholesterol Measurements
Total cholesterol in baseline and after 8 weeks of treatment (Intake period).
Time frame: Baseline and 8th week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Total Cholesterol Measurements | Baseline | 190.1 mg/dL | Standard Deviation 43.6 |
| Intervention | Total Cholesterol Measurements | Week 8 Intake Period | 180.7 mg/dL | Standard Deviation 36.1 |
| Placebo | Total Cholesterol Measurements | Baseline | 178.1 mg/dL | Standard Deviation 26 |
| Placebo | Total Cholesterol Measurements | Week 8 Intake Period | 189.8 mg/dL | Standard Deviation 39.1 |
p-value: <0.05t-test, 2 sided
Secondary
Triglycerides Measurements
Triglycerides measurements in baseline and after 8 weeks of treatment (intake period).
Time frame: Baseline and 8th week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Triglycerides Measurements | Baseline | 137.5 mg/dL | Standard Deviation 42.3 |
| Intervention | Triglycerides Measurements | Week 8 Intake Period | 103.6 mg/dL | Standard Deviation 44.3 |
| Placebo | Triglycerides Measurements | Baseline | 144.3 mg/dL | Standard Deviation 63.5 |
| Placebo | Triglycerides Measurements | Week 8 Intake Period | 124.9 mg/dL | Standard Deviation 56 |
p-value: <0.05t-test, 2 sided