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Effects of a Probiotic in Hypertension (HYPRO)

Primary Purpose

Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Vivomixx®
Placebo
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Experimental and Clinical Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Probiotic

Placebo

Arm Description

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

Two sachets placebo in the evening for 8 weeks

Outcomes

Primary Outcome Measures

Nocturnal systolic blood pressure
Measured by 24h ABPM (mmHg)

Secondary Outcome Measures

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

Full Information

First Posted
April 5, 2019
Last Updated
September 28, 2022
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT03906578
Brief Title
Effects of a Probiotic in Hypertension
Acronym
HYPRO
Official Title
Effect of a Probiotic on Blood Pressure in Low-to-moderate Risk Grade 1 Hypertension - a Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 2, 2019 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Probiotic
Arm Type
Active Comparator
Arm Description
Two sachets Vivomixx® containing 8 strains of life bacteria (9 x 10^11 CFU) in the evening for 8 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Two sachets placebo in the evening for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Vivomixx®
Intervention Description
Microbiotic food supplement with L. paracasei, L. plantarum, L. acidophilus, L. delbrueckii, B. longum, B. infantis, B. breve, S. thermophilus
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo with similar appearance to probiotic
Primary Outcome Measure Information:
Title
Nocturnal systolic blood pressure
Description
Measured by 24h ABPM (mmHg)
Time Frame
After 8 weeks compared to placebo and adjusted to baseline
Secondary Outcome Measure Information:
Title
Nocturnal diastolic blood pressure
Description
Measured by 24h ABPM (mmHg)
Time Frame
After 8 weeks compared to placebo and adjusted to baseline
Title
24h systolic blood pressure
Description
Measured by 24h ABPM (mmHg)
Time Frame
After 8 weeks compared to placebo and adjusted to baseline
Title
24h diastolic blood pressure
Description
Measured by 24h ABPM (mmHg)
Time Frame
After 8 weeks compared to placebo and adjusted to baseline
Title
Office systolic blood pressure
Description
Mean of five consecutive blood pressure measurements (mmHg)
Time Frame
After 8 weeks compared to placebo and adjusted to baseline
Title
Office diastolic blood pressure
Description
Mean of five consecutive blood pressure measurements (mmHg)
Time Frame
After 8 weeks compared to placebo and adjusted to baseline
Title
Reduction of antihypertensive medication
Description
Number and dosage of prescribed medication
Time Frame
After 8 weeks compared to placebo and adjusted to baseline
Title
Glucose variability after standardized breakfasts
Description
Measured by continuous glucose monitoring
Time Frame
After 8 weeks compared to placebo and adjusted to baseline
Title
Gut microbiome
Description
Change of fecal microbiome composition
Time Frame
After 8 weeks compared to placebo and adjusted to baseline
Title
Metabolomics stool and serum
Description
Change of fecal and serum metabolome
Time Frame
After 8 weeks compared to placebo and adjusted to baseline
Title
Change in immune cell phenotypes
Description
Peripheral blood effector T cell frequencies (%)
Time Frame
After 8 weeks compared to placebo and adjusted to baseline
Title
PROMIS-29 domain pain interference
Description
Range 0-10 with 0 indicating no pain
Time Frame
After 8 weeks compared to placebo and adjusted to baseline
Title
PROMIS-29 domain depression
Description
Lower (better) T-score (mean 50, SD 10)
Time Frame
After 8 weeks compared to placebo and adjusted to baseline
Title
PROMIS-29 domain anxiety
Description
Lower (better) T-score (mean 50, SD 10)
Time Frame
After 8 weeks compared to placebo and adjusted to baseline
Title
PROMIS-29 domain physical function
Description
Higher (better) T-score (mean 50, SD 10)
Time Frame
After 8 weeks compared to placebo and adjusted to baseline
Title
PROMIS-29 domain fatigue
Description
Lower (better) T-score (mean 50, SD 10)
Time Frame
After 8 weeks compared to placebo and adjusted to baseline
Title
PROMIS-29 domain sleep disturbance
Description
Lower (better) T-score (mean 50, SD 10)
Time Frame
After 8 weeks compared to placebo and adjusted to baseline
Title
PROMIS-29 domain ability to participate in social roles and activities
Description
Higher (better) T-score (mean 50, SD 10)
Time Frame
After 8 weeks compared to placebo and adjusted to baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anja Mähler, PhD
Phone
+49 30 450 540 323
Email
anja.maehler@charite.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anja Mähler, PhD
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dominik N. Müller, PhD
Organizational Affiliation
Max Delbruck Center (MDC)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ralf Dechend, MD
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Experimental and Clinical Research Center
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anja Mähler, PhD
Phone
+49 30 450 540 323
Email
anja.maehler@charite.de

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
33375942
Citation
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.
Results Reference
background
Links:
URL
https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-020-04973-0
Description
Protocol publication

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Effects of a Probiotic in Hypertension

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