Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
46 participants
INTERVENTIONAL
2019-09-02
2025-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Probiotic
Two sachets Vivomixx® containing 8 strains of life bacteria (9 x 10\^11 CFU) in the evening for 8 weeks
Vivomixx®
Microbiotic food supplement with L. paracasei, L. plantarum, L. acidophilus, L. delbrueckii, B. longum, B. infantis, B. breve, S. thermophilus
Placebo
Two sachets placebo in the evening for 8 weeks
Placebo
Placebo with similar appearance to probiotic
Interventions
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Vivomixx®
Microbiotic food supplement with L. paracasei, L. plantarum, L. acidophilus, L. delbrueckii, B. longum, B. infantis, B. breve, S. thermophilus
Placebo
Placebo with similar appearance to probiotic
Eligibility Criteria
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Inclusion Criteria
* Treated or untreated hypertension (resting office blood pressure 130-159/80-99 mmHg)
* BMI 18.5 - 34.9 kg/m\^2
* 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
Exclusion Criteria
* 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:
50 Years
80 Years
ALL
No
Sponsors
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Charite University, Berlin, Germany
OTHER
Responsible Party
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Kristin Kraeker
Principal Investigator
Principal Investigators
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Anja Mähler, PhD
Role: PRINCIPAL_INVESTIGATOR
Charite University, Berlin, Germany
Dominik N. Müller, PhD
Role: PRINCIPAL_INVESTIGATOR
Max Delbruck Center (MDC)
Ralf Dechend, MD
Role: PRINCIPAL_INVESTIGATOR
Charite University, Berlin, Germany
Locations
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Experimental and Clinical Research Center
Berlin, , Germany
Countries
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References
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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.
Related Links
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Protocol publication
Other Identifiers
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HYPRO
Identifier Type: -
Identifier Source: org_study_id
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