HypertensionNCT02670811
Antihypertensive Effect of Fermented Milk With Lactococcus Lactis on Prehypertensive Subjects
A study testing Fermented milk and Acidified milk in people with Hypertension, run by Centro de Investigación en Alimentación y Desarrollo A.C..
Trial 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 more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Fermented milk and Acidified milk
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Aug 2013to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Systolic blood pressure >130 mmHg
- Diastolic blood pressure > 85 mmHg
Who cannot join
- Pregnant women
- Cardiovascular diseases
- Diabetes
- Cancer
- Dairy allergy
- Lactose intolerance
- Patients receiving angiotensin converting enzyme inhibitors as pharmacological therapy
About this study
Official title: Randomized Double-blind Controlled Clinical Study of the Antihypertensive Effect of Fermented Milk With Lactococcus Lactis NRRL-B50571
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.
- Conditions
- Hypertension
- Being tested
- Fermented milk, Acidified milk
- Keywords
- Hypertension, Fermented Milk, Clinical Study, Randomized, Double-blind
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fermented milkDietary supplement
150 mL daily of fermented milk with Lactococcus lactis NRRL-B50571
Acidified milkDietary supplement
150 mL daily of artificially acidified milk
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Daily consumption of 150 mL of fermented milk with Lactococcus lactis for 8 weeks Receives: Dietary Supplement: Fermented milk |
| Placebo | Placebo comparator | Daily consumption of 150 mL of artificially acidified milk Receives: Dietary Supplement: Acidified milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure Measurements
From randomization (baseline), eight weeks of intervention and two weeks after intervention was over.
Measured: Baseline to 10 weeks
Secondary outcomes (5)
Diastolic Blood Pressure Measurements
From randomization (baseline), eight weeks of intervention and two weeks post-treatment.
Measured: Baseline to 10 weeks
Total Cholesterol Measurements
Total cholesterol in baseline and after 8 weeks of treatment (Intake period).
Measured: Baseline and 8th week
Low Density Lipoproteins Measurements
Low density lipoproteins measurements in baseline and after 8 weeks of treatment (intake period).
Measured: Baseline and 8th week
High Density Lipoproteins
High density lipoproteins measurements in baseline and after 8 weeks of treatment (intake period).
Measured: Baseline and 8th week
Triglycerides Measurements
Triglycerides measurements in baseline and after 8 weeks of treatment (intake period).
Measured: Baseline and 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study startAug 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro de Investigación en Alimentación y Desarrollo A.C.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Belinda Vallejo Galland, PhD, Centro de Investigación en Alimentación y Desarrollo A.C.
- Investigators
- Belinda Vallejo, PhD, Principal investigator, Centro de Investigación en Alimentación y Desarrollo A.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02670811
- Sponsor's protocol ID
- VAGB 001
- Status last verified
- Oct 2023
- First submitted
- 26 Jan 2016
- Last updated
- 12 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data for study protocol, statistical analysis plan, clinical study report and analytic code may be shared upon request.
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-blind Controlled Clinical Study of the Antihypertensive Effect of Fermented Milk With Lactococcus Lactis NRRL-B50571
- ClinicalTrials.gov ID
- NCT02670811
- Acronym / sponsor ID
- VAGB 001
- Conditions
- Hypertension
- Keywords
- Hypertension, Fermented Milk, Clinical Study, Randomized, Double-blind
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Centro de Investigación en Alimentación y Desarrollo A.C.University, hospital or other
- Study start
- Aug 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 2 Feb 2016 (estimated)
- Results
- Posted 11 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: Fermented milkDaily consumption of 150 mL of fermented milk with Lactococcus lactis for 8 weeks |
| Placebo | Placebo comparator | Dietary Supplement: Acidified milkDaily consumption of 150 mL of artificially acidified milk |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Systolic blood pressure >130 mmHg
- Diastolic blood pressure > 85 mmHg
Key exclusion criteria (7 listed)
- Pregnant women
- Cardiovascular diseases
- Diabetes
- Cancer
- Dairy allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fermented milk150 mL daily of fermented milk with Lactococcus lactis NRRL-B50571 | Dietary supplement | Intervention |
| Acidified milk150 mL daily of artificially acidified milk | Dietary supplement | Placebo |
Primary outcome
Systolic Blood Pressure Measurements
Time frame: Baseline to 10 weeks
From randomization (baseline), eight weeks of intervention and two weeks after intervention was over.
5 secondary outcomes
Diastolic Blood Pressure Measurements
Time frame: Baseline to 10 weeks
Total Cholesterol Measurements
Time frame: Baseline and 8th week
Low Density Lipoproteins Measurements
Time frame: Baseline and 8th week
High Density Lipoproteins
Time frame: Baseline and 8th week
Triglycerides Measurements
Time frame: Baseline and 8th week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data for study protocol, statistical analysis plan, clinical study report and analytic code may be shared upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Belinda Vallejo, PhD principal investigator
Centro de Investigación en Alimentación y Desarrollo A.C.
Questions about this trial
What is this clinical trial studying?
A study testing Fermented milk and Acidified milk in people with Hypertension, run by Centro de Investigación en Alimentación y Desarrollo A.C..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Blood Pressure Measurements (time frame: Baseline to 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2023.