Effects of a Probiotic in Hypertension (HYPRO)

Effect of a Probiotic on Blood Pressure in Low-to-moderate Risk Grade 1 Hypertension - a Randomized Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hypertension
• Intervention / Treatment: Dietary supplement: Vivomixx®; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13125
    • Experimental and Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Probiotic; Two sachets Vivomixx® containing 8 strains of life bacteria (9 x 10^11 CFU) in the evening for 8 weeks	Dietary supplement: Vivomixx®; Microbiotic food supplement with L. paracasei, L. plantarum, L. acidophilus, L. delbrueckii, B. longum, B. infantis, B. breve, S. thermophilus
Placebo Comparator: Placebo; Two sachets placebo in the evening for 8 weeks	Other: Placebo; Placebo with similar appearance to probiotic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nocturnal systolic blood pressure	Measured by 24h ABPM (mmHg)	After 8 weeks compared to placebo and adjusted to baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nocturnal diastolic blood pressure	Measured by 24h ABPM (mmHg)	After 8 weeks compared to placebo and adjusted to baseline
24h systolic blood pressure	Measured by 24h ABPM (mmHg)	After 8 weeks compared to placebo and adjusted to baseline
24h diastolic blood pressure	Measured by 24h ABPM (mmHg)	After 8 weeks compared to placebo and adjusted to baseline
Office systolic blood pressure	Mean of five consecutive blood pressure measurements (mmHg)	After 8 weeks compared to placebo and adjusted to baseline
Office diastolic blood pressure	Mean of five consecutive blood pressure measurements (mmHg)	After 8 weeks compared to placebo and adjusted to baseline
Reduction of antihypertensive medication	Number and dosage of prescribed medication	After 8 weeks compared to placebo and adjusted to baseline
Glucose variability after standardized breakfasts	Measured by continuous glucose monitoring	After 8 weeks compared to placebo and adjusted to baseline
Gut microbiome	Change of fecal microbiome composition	After 8 weeks compared to placebo and adjusted to baseline
Metabolomics stool and serum	Change of fecal and serum metabolome	After 8 weeks compared to placebo and adjusted to baseline
Change in immune cell phenotypes	Peripheral blood effector T cell frequencies (%)	After 8 weeks compared to placebo and adjusted to baseline
PROMIS-29 domain pain interference	Range 0-10 with 0 indicating no pain	After 8 weeks compared to placebo and adjusted to baseline
PROMIS-29 domain depression	Lower (better) T-score (mean 50, SD 10)	After 8 weeks compared to placebo and adjusted to baseline
PROMIS-29 domain anxiety	Lower (better) T-score (mean 50, SD 10)	After 8 weeks compared to placebo and adjusted to baseline
PROMIS-29 domain physical function	Higher (better) T-score (mean 50, SD 10)	After 8 weeks compared to placebo and adjusted to baseline
PROMIS-29 domain fatigue	Lower (better) T-score (mean 50, SD 10)	After 8 weeks compared to placebo and adjusted to baseline
PROMIS-29 domain sleep disturbance	Lower (better) T-score (mean 50, SD 10)	After 8 weeks compared to placebo and adjusted to baseline
PROMIS-29 domain ability to participate in social roles and activities	Higher (better) T-score (mean 50, SD 10)	After 8 weeks compared to placebo and adjusted to baseline

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Dominik N. Müller, PhD, Max Delbruck Center (MDC); Principal Investigator: Ralf Dechend, MD, Charite University, Berlin, Germany; Principal Investigator: Anja Mähler, PhD, Charite University, Berlin, Germany

Publications and helpful links

General Publications

• Mahler A, Wilck N, Rauch G, Dechend R, Muller DN. Effect of a probiotic on blood pressure in grade 1 hypertension (HYPRO): protocol of a randomized controlled study. Trials. 2020 Dec 29;21(1):1032. doi: 10.1186/s13063-020-04973-0.

Helpful Links

• Protocol publication

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2019
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: April 5, 2019
• First Submitted That Met QC Criteria: April 5, 2019
• First Posted (Actual): April 8, 2019

Study Record Updates

• Last Update Posted (Actual): July 9, 2024
• Last Update Submitted That Met QC Criteria: July 8, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: HYPRO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results of reported articles (text, tables, figures, supplemental data) will be shared after deidentification.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication.
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No