Trial Outcomes & Findings for Antihypertensive Effect of Fermented Milk With Lactococcus Lactis on Prehypertensive Subjects (NCT NCT02670811)
NCT ID: NCT02670811
Last Updated: 2023-10-12
Results Overview
From randomization (baseline), eight weeks of intervention and two weeks after intervention was over.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
Baseline to 10 weeks
Results posted on
2023-10-12
Participant Flow
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.
Participant milestones
| Measure |
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
|
Placebo
Daily consumption of 150 mL of artificially acidified milk
Acidified milk: 150 mL daily of artificially acidified milk
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
|
Overall Study
COMPLETED
|
17
|
18
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Antihypertensive Effect of Fermented Milk With Lactococcus Lactis on Prehypertensive Subjects
Baseline characteristics by cohort
| Measure |
Intervention
n=18 Participants
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
|
Placebo
n=18 Participants
Daily consumption of 150 mL of artificially acidified milk
Acidified milk: 150 mL daily of artificially acidified milk
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.5 Years
STANDARD_DEVIATION 11.7 • n=99 Participants
|
44.6 Years
STANDARD_DEVIATION 9.2 • n=107 Participants
|
42.5 Years
STANDARD_DEVIATION 10.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Region of Enrollment
Mexico
|
18 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Systolic blood pressure
|
131.8 mmHg
STANDARD_DEVIATION 5.6 • n=99 Participants
|
134.3 mmHg
STANDARD_DEVIATION 7 • n=107 Participants
|
133.1 mmHg
STANDARD_DEVIATION 6.4 • n=206 Participants
|
|
Diastolic blood pressure
|
87.7 mmHg
STANDARD_DEVIATION 5.1 • n=99 Participants
|
89.3 mmHg
STANDARD_DEVIATION 5.8 • n=107 Participants
|
88.6 mmHg
STANDARD_DEVIATION 5.4 • n=206 Participants
|
|
Weight
|
80.5 kilograms
STANDARD_DEVIATION 14.6 • n=99 Participants
|
85.8 kilograms
STANDARD_DEVIATION 18.2 • n=107 Participants
|
83.2 kilograms
STANDARD_DEVIATION 16.5 • n=206 Participants
|
|
Height
|
1.63 meters
STANDARD_DEVIATION 0.1 • n=99 Participants
|
1.67 meters
STANDARD_DEVIATION 0.1 • n=107 Participants
|
1.65 meters
STANDARD_DEVIATION 0.1 • n=206 Participants
|
|
Total cholesterol
|
190.1 mg/dL
STANDARD_DEVIATION 43.6 • n=99 Participants
|
178.1 mg/dL
STANDARD_DEVIATION 26 • n=107 Participants
|
184.1 mg/dL
STANDARD_DEVIATION 35.9 • n=206 Participants
|
|
Low density lipoprotein
|
127.1 mg/dL
STANDARD_DEVIATION 43 • n=99 Participants
|
114.7 mg/dL
STANDARD_DEVIATION 26 • n=107 Participants
|
120.9 mg/dL
STANDARD_DEVIATION 35.5 • n=206 Participants
|
|
High density lipoprotein
|
37.9 mg/dL
STANDARD_DEVIATION 8.7 • n=99 Participants
|
37.8 mg/dL
STANDARD_DEVIATION 6.5 • n=107 Participants
|
37.9 mg/dL
STANDARD_DEVIATION 7.6 • n=206 Participants
|
|
Triglycerides
|
137.5 mg/dL
STANDARD_DEVIATION 42.3 • n=99 Participants
|
144.3 mg/dL
STANDARD_DEVIATION 63.5 • n=107 Participants
|
141 mg/dL
STANDARD_DEVIATION 53.3 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to 10 weeksFrom randomization (baseline), eight weeks of intervention and two weeks after intervention was over.
Outcome measures
| Measure |
Intervention
n=18 Participants
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
|
Placebo
n=18 Participants
Daily consumption of 150 mL of artificially acidified milk
Acidified milk: 150 mL daily of artificially acidified milk
|
|---|---|---|
|
Systolic Blood Pressure Measurements
Baseline
|
131.8 mmHg
Standard Deviation 5.7
|
134.3 mmHg
Standard Deviation 7
|
|
Systolic Blood Pressure Measurements
Week 1 Intake Period
|
122.1 mmHg
Standard Deviation 13.6
|
127.4 mmHg
Standard Deviation 11.3
|
|
Systolic Blood Pressure Measurements
Week 2 Intake Period
|
121.3 mmHg
Standard Deviation 9.6
|
125.8 mmHg
Standard Deviation 10.3
|
|
Systolic Blood Pressure Measurements
Week 3 Intake Period
|
120 mmHg
Standard Deviation 11.4
|
127.1 mmHg
Standard Deviation 8.3
|
|
Systolic Blood Pressure Measurements
Week 4 Intake Period
|
121.1 mmHg
Standard Deviation 14.2
|
125 mmHg
Standard Deviation 8.5
|
|
Systolic Blood Pressure Measurements
Week 5 Intake Period
|
116.6 mmHg
Standard Deviation 12.3
|
124.8 mmHg
Standard Deviation 11
|
|
Systolic Blood Pressure Measurements
Week 6 Intake Period
|
120.4 mmHg
Standard Deviation 11.6
|
126.4 mmHg
Standard Deviation 10.5
|
|
Systolic Blood Pressure Measurements
Week 7 Intake Period
|
118.9 mmHg
Standard Deviation 12.6
|
125.6 mmHg
Standard Deviation 10
|
|
Systolic Blood Pressure Measurements
Week 8 Intake Period
|
122.5 mmHg
Standard Deviation 8.3
|
127.6 mmHg
Standard Deviation 8.9
|
|
Systolic Blood Pressure Measurements
Week 1 Post-Treatment
|
122.3 mmHg
Standard Deviation 12.9
|
127.3 mmHg
Standard Deviation 9.6
|
|
Systolic Blood Pressure Measurements
Week 2 Post-Treatment
|
124 mmHg
Standard Deviation 12.6
|
128 mmHg
Standard Deviation 10.2
|
SECONDARY outcome
Timeframe: Baseline to 10 weeksFrom randomization (baseline), eight weeks of intervention and two weeks post-treatment.
Outcome measures
| Measure |
Intervention
n=18 Participants
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
|
Placebo
n=18 Participants
Daily consumption of 150 mL of artificially acidified milk
Acidified milk: 150 mL daily of artificially acidified milk
|
|---|---|---|
|
Diastolic Blood Pressure Measurements
Week 2 Post-Treatment
|
84.7 mmHg
Standard Deviation 9.1
|
86.3 mmHg
Standard Deviation 6.2
|
|
Diastolic Blood Pressure Measurements
Baseline
|
87.7 mmHg
Standard Deviation 5.1
|
89.4 mmHg
Standard Deviation 5.7
|
|
Diastolic Blood Pressure Measurements
Week 1 Intake Period
|
82.3 mmHg
Standard Deviation 9.5
|
85.9 mmHg
Standard Deviation 7.6
|
|
Diastolic Blood Pressure Measurements
Week 2 Intake Period
|
80.8 mmHg
Standard Deviation 8
|
84.2 mmHg
Standard Deviation 5.9
|
|
Diastolic Blood Pressure Measurements
Week 3 Intake Period
|
81.9 mmHg
Standard Deviation 8
|
85.7 mmHg
Standard Deviation 7.9
|
|
Diastolic Blood Pressure Measurements
Week 4 Intake Period
|
80.4 mmHg
Standard Deviation 10.7
|
84.4 mmHg
Standard Deviation 6.7
|
|
Diastolic Blood Pressure Measurements
Week 5 Intake Period
|
80.7 mmHg
Standard Deviation 9.1
|
84.5 mmHg
Standard Deviation 8.5
|
|
Diastolic Blood Pressure Measurements
Week 6 Intake Period
|
82.6 mmHg
Standard Deviation 9.6
|
84.1 mmHg
Standard Deviation 7.8
|
|
Diastolic Blood Pressure Measurements
Week 7 Intake Period
|
80.7 mmHg
Standard Deviation 11.1
|
84.9 mmHg
Standard Deviation 7
|
|
Diastolic Blood Pressure Measurements
Week 8 Intake Period
|
83.7 mmHg
Standard Deviation 5.9
|
86.4 mmHg
Standard Deviation 5
|
|
Diastolic Blood Pressure Measurements
Week 1 Post-Treatment
|
84.3 mmHg
Standard Deviation 9.3
|
87.1 mmHg
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: Baseline and 8th weekTotal cholesterol in baseline and after 8 weeks of treatment (Intake period).
Outcome measures
| Measure |
Intervention
n=18 Participants
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
|
Placebo
n=18 Participants
Daily consumption of 150 mL of artificially acidified milk
Acidified milk: 150 mL daily of artificially acidified milk
|
|---|---|---|
|
Total Cholesterol Measurements
Baseline
|
190.1 mg/dL
Standard Deviation 43.6
|
178.1 mg/dL
Standard Deviation 26
|
|
Total Cholesterol Measurements
Week 8 Intake Period
|
180.7 mg/dL
Standard Deviation 36.1
|
189.8 mg/dL
Standard Deviation 39.1
|
SECONDARY outcome
Timeframe: Baseline and 8th weekLow density lipoproteins measurements in baseline and after 8 weeks of treatment (intake period).
Outcome measures
| Measure |
Intervention
n=18 Participants
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
|
Placebo
n=18 Participants
Daily consumption of 150 mL of artificially acidified milk
Acidified milk: 150 mL daily of artificially acidified milk
|
|---|---|---|
|
Low Density Lipoproteins Measurements
Baseline
|
127.1 mg/dL
Standard Deviation 43
|
114.7 mg/dL
Standard Deviation 26
|
|
Low Density Lipoproteins Measurements
Week 8 Intake Period
|
116.6 mg/dL
Standard Deviation 37.8
|
122.7 mg/dL
Standard Deviation 31.8
|
SECONDARY outcome
Timeframe: Baseline and 8th weekHigh density lipoproteins measurements in baseline and after 8 weeks of treatment (intake period).
Outcome measures
| Measure |
Intervention
n=18 Participants
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
|
Placebo
n=18 Participants
Daily consumption of 150 mL of artificially acidified milk
Acidified milk: 150 mL daily of artificially acidified milk
|
|---|---|---|
|
High Density Lipoproteins
Baseline
|
37.9 mg/dL
Standard Deviation 8.7
|
37.8 mg/dL
Standard Deviation 6.5
|
|
High Density Lipoproteins
Week 8 Intake Period
|
43.2 mg/dL
Standard Deviation 8.1
|
42.4 mg/dL
Standard Deviation 7.6
|
SECONDARY outcome
Timeframe: Baseline and 8th weekTriglycerides measurements in baseline and after 8 weeks of treatment (intake period).
Outcome measures
| Measure |
Intervention
n=18 Participants
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
|
Placebo
n=18 Participants
Daily consumption of 150 mL of artificially acidified milk
Acidified milk: 150 mL daily of artificially acidified milk
|
|---|---|---|
|
Triglycerides Measurements
Baseline
|
137.5 mg/dL
Standard Deviation 42.3
|
144.3 mg/dL
Standard Deviation 63.5
|
|
Triglycerides Measurements
Week 8 Intake Period
|
103.6 mg/dL
Standard Deviation 44.3
|
124.9 mg/dL
Standard Deviation 56
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Belinda Vallejo Galland
Centro de Investigación en Alimentación y Desarrollo, A.C.
Phone: 526622892400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place