Effects of a Probiotic in Hypertension

Study Overview
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Brief Summary
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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.

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

Conditions
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Hypertension

Intervention / Treatment
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* Dietary Supplement: Vivomixx®
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 |