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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Daily consumption of 150 mL of fermented milk with Lactococcus lactis for 8 weeks |
|
| Placebo | Placebo Comparator | Daily consumption of 150 mL of artificially acidified milk |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fermented milk | Dietary Supplement | 150 mL daily of fermented milk with Lactococcus lactis NRRL-B50571 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure Measurements | From randomization (baseline), eight weeks of intervention and two weeks after intervention was over. | Baseline to 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Diastolic Blood Pressure Measurements | From randomization (baseline), eight weeks of intervention and two weeks post-treatment. | Baseline to 10 weeks |
| Total Cholesterol Measurements | Total cholesterol in baseline and after 8 weeks of treatment (Intake period). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Belinda Vallejo, PhD | Centro de Investigación en Alimentación y Desarrollo A.C. | Principal Investigator |
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Individual participant data for study protocol, statistical analysis plan, clinical study report and analytic code may be shared upon request.
October 2023 to December 2023.
Researchers who may benefit for the design on their clinical trial.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Placebo | Daily consumption of 150 mL of artificially acidified milk Acidified milk: 150 mL daily of artificially acidified milk |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Systolic Blood Pressure Measurements | From randomization (baseline), eight weeks of intervention and two weeks after intervention was over. | Posted | Mean | Standard Deviation | mmHg | Baseline to 10 weeks |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Belinda Vallejo Galland | Centro de Investigación en Alimentación y Desarrollo, A.C. | 526622892400 | 365 | vallejo@ciad.mx |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D043302 | Cultured Milk Products |
| ID | Term |
|---|---|
| D008892 | Milk |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Acidified milk | Dietary Supplement | 150 mL daily of artificially acidified milk |
|
| Baseline and 8th week |
| Low Density Lipoproteins Measurements | Low density lipoproteins measurements in baseline and after 8 weeks of treatment (intake period). | Baseline and 8th week |
| High Density Lipoproteins | High density lipoproteins measurements in baseline and after 8 weeks of treatment (intake period). | Baseline and 8th week |
| Triglycerides Measurements | Triglycerides measurements in baseline and after 8 weeks of treatment (intake period). | Baseline and 8th week |
Daily consumption of 150 mL of artificially acidified milk
Acidified milk: 150 mL daily of artificially acidified milk
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| Systolic blood pressure | Mean | Standard Deviation | mmHg |
|
| Diastolic blood pressure | Mean | Standard Deviation | mmHg |
|
| Weight | Mean | Standard Deviation | kilograms |
|
| Height | Mean | Standard Deviation | meters |
|
| Total cholesterol | Mean | Standard Deviation | mg/dL |
|
| Low density lipoprotein | Mean | Standard Deviation | mg/dL |
|
| High density lipoprotein | Mean | Standard Deviation | mg/dL |
|
| Triglycerides | Mean | Standard Deviation | mg/dL |
|
| Units | Counts |
|---|---|
| Participants |
|
|
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| Secondary | Diastolic Blood Pressure Measurements | From randomization (baseline), eight weeks of intervention and two weeks post-treatment. | Posted | Mean | Standard Deviation | mmHg | Baseline to 10 weeks |
|
|
|
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| Secondary | Total Cholesterol Measurements | Total cholesterol in baseline and after 8 weeks of treatment (Intake period). | Posted | Mean | Standard Deviation | mg/dL | Baseline and 8th week |
|
|
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| Secondary | Low Density Lipoproteins Measurements | Low density lipoproteins measurements in baseline and after 8 weeks of treatment (intake period). | Posted | Mean | Standard Deviation | mg/dL | Baseline and 8th week |
|
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| Secondary | High Density Lipoproteins | High density lipoproteins measurements in baseline and after 8 weeks of treatment (intake period). | Posted | Mean | Standard Deviation | mg/dL | Baseline and 8th week |
|
|
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| Secondary | Triglycerides Measurements | Triglycerides measurements in baseline and after 8 weeks of treatment (intake period). | Posted | Mean | Standard Deviation | mg/dL | Baseline and 8th week |
|
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Placebo | Daily consumption of 150 mL of artificially acidified milk Acidified milk: 150 mL daily of artificially acidified milk | 0 | 18 | 0 | 18 |
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| D000074421 |
| Fermented Foods |
| D003611 | Dairy Products |
| D005502 | Food |
| D019602 | Food and Beverages |
| Week 2 Intake Period |
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| Week 3 Intake Period |
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| Week 4 Intake Period |
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| Week 5 Intake Period |
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| Week 6 Intake Period |
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| Week 7 Intake Period |
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| Week 8 Intake Period |
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| Week 1 Post-Treatment |
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| Week 2 Post-Treatment |
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