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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
46
Experimental and Clinical Research Center
Berlin, Germany
Nocturnal systolic blood pressure
Measured by 24h ABPM (mmHg)
Time frame: After 8 weeks compared to placebo and adjusted to baseline
Nocturnal diastolic blood pressure
Measured by 24h ABPM (mmHg)
Time frame: After 8 weeks compared to placebo and adjusted to baseline
24h systolic blood pressure
Measured by 24h ABPM (mmHg)
Time frame: After 8 weeks compared to placebo and adjusted to baseline
24h diastolic blood pressure
Measured by 24h ABPM (mmHg)
Time frame: After 8 weeks compared to placebo and adjusted to baseline
Office systolic blood pressure
Mean of five consecutive blood pressure measurements (mmHg)
Time frame: After 8 weeks compared to placebo and adjusted to baseline
Office diastolic blood pressure
Mean of five consecutive blood pressure measurements (mmHg)
Time frame: After 8 weeks compared to placebo and adjusted to baseline
Reduction of antihypertensive medication
Number and dosage of prescribed medication
Time frame: After 8 weeks compared to placebo and adjusted to baseline
Glucose variability after standardized breakfasts
Measured by continuous glucose monitoring
Time frame: After 8 weeks compared to placebo and adjusted to baseline
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Gut microbiome
Change of fecal microbiome composition
Time frame: After 8 weeks compared to placebo and adjusted to baseline
Metabolomics stool and serum
Change of fecal and serum metabolome
Time frame: After 8 weeks compared to placebo and adjusted to baseline
Change in immune cell phenotypes
Peripheral blood effector T cell frequencies (%)
Time frame: After 8 weeks compared to placebo and adjusted to baseline
PROMIS-29 domain pain interference
Range 0-10 with 0 indicating no pain
Time frame: After 8 weeks compared to placebo and adjusted to baseline
PROMIS-29 domain depression
Lower (better) T-score (mean 50, SD 10)
Time frame: After 8 weeks compared to placebo and adjusted to baseline
PROMIS-29 domain anxiety
Lower (better) T-score (mean 50, SD 10)
Time frame: After 8 weeks compared to placebo and adjusted to baseline
PROMIS-29 domain physical function
Higher (better) T-score (mean 50, SD 10)
Time frame: After 8 weeks compared to placebo and adjusted to baseline
PROMIS-29 domain fatigue
Lower (better) T-score (mean 50, SD 10)
Time frame: After 8 weeks compared to placebo and adjusted to baseline
PROMIS-29 domain sleep disturbance
Lower (better) T-score (mean 50, SD 10)
Time frame: 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)
Time frame: After 8 weeks compared to placebo and adjusted to baseline