Evidence map›Paper›PMID 33375942›Full record

ArticleTrials2020

Effect of a probiotic on blood pressure in grade 1 hypertension (HYPRO): protocol of a randomized controlled study.

Anja Mähler, Nicola Wilck, Geraldine Rauch, Ralf Dechend, Dominik N Müller

2 registry-linked trialsOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
2.0field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02971787 nacompletednot on this map

Influence of Increased Salt Intake on Lactobacillus Abundance in Healthy Men

TypeinterventionalSponsorCharite University, Berlin, GermanyRan2016 to 2017Enrolled8ConditionsHealthy Volunteers, Probiotics, SodiumArmsProbiotics, Salt
NCT03906578 naunknown statusnot on this map

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

TypeinterventionalSponsorCharite University, Berlin, GermanyRan2019 to 2025Enrolled46ConditionsHypertensionArmsVivomixx®, Placebo
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 22 citations in OpenAlex.

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  3. Food as Medicine for Hypertension: Microbiota as Mediators.Hypertension (Dallas, Tex. : 1979) · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 1 country.

Anja MählerExperimental and Clinical Research Center, a cooperation between Charité - Universitätsmedizin Berlin and Max Delbruck Center for Molecular Medicine, Berlin, Germany. anja.maehler@charite.de.ORCID http://orcid.org/0000-0002-3904-5789
Nicola WilckExperimental and Clinical Research Center, a cooperation between Charité - Universitätsmedizin Berlin and Max Delbruck Center for Molecular Medicine, Berlin, Germany.
Geraldine RauchBerlin Institute of Health, Berlin, Germany.
Ralf DechendExperimental and Clinical Research Center, a cooperation between Charité - Universitätsmedizin Berlin and Max Delbruck Center for Molecular Medicine, Berlin, Germany.
Dominik N MüllerExperimental and Clinical Research Center, a cooperation between Charité - Universitätsmedizin Berlin and Max Delbruck Center for Molecular Medicine, Berlin, Germany.
Max Delbrück Center · DEHumboldt-Universität zu Berlin · DE

Funding

Berlin Institute of Health BIH Budget 2019
6 · The paper itself

Abstract

backgroundArterial hypertension is a major risk factor for cardiovascular disease and leads to target organ damage including stroke, heart failure, and kidney disease. About 1.5 billion people worldwide have hypertension, and it is estimated that it causes about 8 million deaths each year. Although there are several drugs available to lower blood pressure (BP), a great proportion of treated patients does not reach recommended treatment targets. Typical antihypertensive drugs target the vessels, the kidneys, and the heart. However, our gut microbiota also influences cardiovascular health, and gut dysbiosis is associated with hypertension. In this study protocol, we investigate the potential BP-lowering effect of a probiotic in patients with grade 1 hypertension.

methodsThis study is an exploratory, randomized, double-blind, placebo-controlled, parallel-group study. One hundred ten patients with grade 1 hypertension (treated or untreated) will be randomized to either the probiotic Vivomixx® or placebo. The primary endpoint is the nocturnal systolic BP measured by ambulatory blood pressure monitoring after 8 weeks adjusted for the baseline value. The secondary endpoints are changes from baseline in nocturnal diastolic BP, antihypertensive medication, fecal microbiome composition, fecal and serum metabolome, immune cell phenotypes, glucose variability after three standardized breakfasts, and health-related quality of life (PROMIS-29). We also assess the safety profile of the intervention. DISCUSSION: We postulate that various administrated bacteria (Lactobacilli, Bifidobacteria, and Streptococcus thermophilus) convert dietary components into active metabolites that positively affect immune cell function. A reduction of pro-inflammatory immune cell function could promote a BP-lowering effect.

trial registrationClinicalTrials.gov NCT03906578 . Registered on 08 April 2019.

Indexed as

HypertensionProbioticsAntihypertensive AgentsBlood PressureBlood Pressure Monitoring, AmbulatoryDouble-Blind MethodHumansQuality of LifeRandomized Controlled Trials as TopicAntihypertensive AgentsBlood pressureGlucose variabilityHypertensionImmune cell phenotypeMetabolomeMicrobiomeProbioticRandomized controlled trialVivomixx®

Identifiers

PMID33375942
PMCPMC7771080
OpenAlexW3117725468

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.