Antihypertensive Effect of Fermented Milk With Lactococcus Lactis on Prehypertensive Subjects

Centro de Investigación en Alimentación y Desarrollo A.C.

Status: Completed

Conditions: Hypertension

Treatments: Dietary Supplement: Acidified milk; Dietary Supplement: Fermented milk

Study type: Interventional

Funder types: Other

Identifiers

NCT02670811

VAGB 001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 25 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

36 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

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

Treatment:

Dietary Supplement: Fermented milk

Placebo

Placebo Comparator group

Description:

Daily consumption of 150 mL of artificially acidified milk

Treatment:

Dietary Supplement: Acidified milk