NCT02670811

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Aug 2013

Shorter than P25 for not_applicable hypertension

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 2, 2016

Completed
8 months until next milestone

Results Posted

Study results publicly available

October 11, 2016

Completed
Last Updated

October 12, 2023

Status Verified

October 1, 2023

Enrollment Period

4 months

First QC Date

January 26, 2016

Results QC Date

July 5, 2016

Last Update Submit

October 3, 2023

Conditions

Hypertension

Keywords

HypertensionFermented MilkClinical StudyRandomizedDouble-blind

Outcome Measures

Primary Outcomes (1)

  • Systolic Blood Pressure Measurements

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

    Baseline to 10 weeks

Secondary Outcomes (5)

  • Diastolic Blood Pressure Measurements

    Baseline to 10 weeks

  • Total Cholesterol Measurements

    Baseline and 8th week

  • Low Density Lipoproteins Measurements

    Baseline and 8th week

  • High Density Lipoproteins

    Baseline and 8th week

  • Triglycerides Measurements

    Baseline and 8th week

Study Arms (2)

Intervention

EXPERIMENTAL

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

Dietary Supplement: Fermented milk

Placebo

PLACEBO COMPARATOR

Daily consumption of 150 mL of artificially acidified milk

Dietary Supplement: Acidified milk

Interventions

Fermented milkDIETARY_SUPPLEMENT

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

Intervention
Acidified milkDIETARY_SUPPLEMENT

150 mL daily of artificially acidified milk

Placebo

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Interventions

Cultured Milk Products

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

MilkBeveragesDiet, Food, and NutritionPhysiological PhenomenaFermented FoodsDairy ProductsFoodFood and Beverages

Results Point of Contact

Title
Dr. Belinda Vallejo Galland
Organization
Centro de Investigación en Alimentación y Desarrollo, A.C.
vallejo@ciad.mx
526622892400

Study Officials

  • Belinda Vallejo, PhD

    Centro de Investigación en Alimentación y Desarrollo A.C.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

January 26, 2016

First Posted

February 2, 2016

Study Start

August 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

October 12, 2023

Results First Posted

October 11, 2016

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

Individual participant data for study protocol, statistical analysis plan, clinical study report and analytic code may be shared upon request.

Shared Documents
STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
Time Frame
October 2023 to December 2023.
Access Criteria
Researchers who may benefit for the design on their clinical trial.