Effects of a Probiotic in Hypertension (HYPRO)

Charité University Medicine Berlin

Status: Active, not recruiting

Conditions: Hypertension

Treatments: Other: Placebo; Dietary Supplement: Vivomixx®

Study type: Interventional

Funder types: Other

Identifiers

NCT03906578

HYPRO

Details and patient eligibility

About

High blood pressure is a major risk factor for cardiovascular events, including stroke, heart and kidney failure. Typical anti-hypertensive drugs target vessels, the kidneys or the heart. Here we propose a randomized, placebo-controlled study to test the blood pressure-lowering effect of a probiotic in 110 patients with grade 1 hypertension. In addition, we will investigate glucose variability, fecal bacterial metabolome, peripheral blood effector T cell frequencies (%) and health-related quality of life.

Enrollment: 46 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and postmenopausal women
• Treated or untreated hypertension (resting office blood pressure 130-159/80-99 mmHg)
• BMI 18.5 - 34.9 kg/m^2

Exclusion criteria

• Secondary causes of hypertension
• Known target organ damage
• 10 years cardiovascular risk score of >20%
• Diabetes
• Established cardiovascular or renal disease
• Other serious diseases
• Recent use of antibiotics
• Specialized diets, e.g. use of probiotics

Comments:

• Two inclusion criteria were changed in June 2021 to improve recruitment
• Age was changed from 50-75 to 50-80 years
• Resting blood pressure was changed from 140-159/90-99 to 130-159/80-99 mmHg

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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46 participants in 2 patient groups, including a placebo group

Probiotic

Active Comparator group

Description:

Two sachets Vivomixx® containing 8 strains of life bacteria (9 x 10\^11 CFU) in the evening for 8 weeks

Treatment:

Dietary Supplement: Vivomixx®

Placebo

Placebo Comparator group

Description:

Two sachets placebo in the evening for 8 weeks

Treatment:

Other: Placebo