Clinical trial NCT03906578: Effects of a Probiotic in Hypertension
Official title: Effect of a Probiotic on Blood Pressure in Low-to-moderate Risk Grade 1 Hypertension - a Randomized Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hypertension
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2019-04-08
Enrollment: 46
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Nocturnal systolic blood pressure
timeFrame: After 8 weeks compared to placebo and adjusted to baseline
Secondary outcomes:
measure: Nocturnal diastolic blood pressure
timeFrame: After 8 weeks compared to placebo and adjusted to baseline
measure: 24h systolic blood pressure
timeFrame: After 8 weeks compared to placebo and adjusted to baseline
measure: 24h diastolic blood pressure
timeFrame: After 8 weeks compared to placebo and adjusted to baseline
measure: Office systolic blood pressure
timeFrame: After 8 weeks compared to placebo and adjusted to baseline
measure: Office diastolic blood pressure
timeFrame: After 8 weeks compared to placebo and adjusted to baseline
measure: Reduction of antihypertensive medication
timeFrame: After 8 weeks compared to placebo and adjusted to baseline
measure: Glucose variability after standardized breakfasts
timeFrame: After 8 weeks compared to placebo and adjusted to baseline
measure: Gut microbiome
timeFrame: After 8 weeks compared to placebo and adjusted to baseline
measure: Metabolomics stool and serum
timeFrame: After 8 weeks compared to placebo and adjusted to baseline
measure: Change in immune cell phenotypes
timeFrame: After 8 weeks compared to placebo and adjusted to baseline
measure: PROMIS-29 domain pain interference
timeFrame: After 8 weeks compared to placebo and adjusted to baseline
measure: PROMIS-29 domain depression
timeFrame: After 8 weeks compared to placebo and adjusted to baseline
measure: PROMIS-29 domain anxiety
timeFrame: After 8 weeks compared to placebo and adjusted to baseline
measure: PROMIS-29 domain physical function
timeFrame: After 8 weeks compared to placebo and adjusted to baseline
measure: PROMIS-29 domain fatigue
timeFrame: After 8 weeks compared to placebo and adjusted to baseline
measure: PROMIS-29 domain sleep disturbance
timeFrame: After 8 weeks compared to placebo and adjusted to baseline
measure: PROMIS-29 domain ability to participate in social roles and activities
timeFrame: After 8 weeks compared to placebo and adjusted to baseline
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Experimental and Clinical Research Center
Study officials:
affiliation: Charite University, Berlin, Germany
name: Anja Mähler, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Max Delbruck Center (MDC)
name: Dominik N. Müller, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Charite University, Berlin, Germany
name: Ralf Dechend, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.