Hypertension
Conditions
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.
Interventions
DIETARY_SUPPLEMENTVivomixx®
Microbiotic food supplement with L. paracasei, L. plantarum, L. acidophilus, L. delbrueckii, B. longum, B. infantis, B. breve, S. thermophilus
OTHERPlacebo
Placebo with similar appearance to probiotic
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nocturnal systolic blood pressure | After 8 weeks compared to placebo and adjusted to baseline | Measured by 24h ABPM (mmHg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in immune cell phenotypes | After 8 weeks compared to placebo and adjusted to baseline | Peripheral blood effector T cell frequencies (%) |
| PROMIS-29 domain pain interference | After 8 weeks compared to placebo and adjusted to baseline | Range 0-10 with 0 indicating no pain |
| Nocturnal diastolic blood pressure | After 8 weeks compared to placebo and adjusted to baseline | Measured by 24h ABPM (mmHg) |
| 24h systolic blood pressure | After 8 weeks compared to placebo and adjusted to baseline | Measured by 24h ABPM (mmHg) |
| 24h diastolic blood pressure | After 8 weeks compared to placebo and adjusted to baseline | Measured by 24h ABPM (mmHg) |
| Office systolic blood pressure | After 8 weeks compared to placebo and adjusted to baseline | Mean of five consecutive blood pressure measurements (mmHg) |
| Office diastolic blood pressure | After 8 weeks compared to placebo and adjusted to baseline | Mean of five consecutive blood pressure measurements (mmHg) |
| Reduction of antihypertensive medication | After 8 weeks compared to placebo and adjusted to baseline | Number and dosage of prescribed medication |
| Metabolomics stool and serum | After 8 weeks compared to placebo and adjusted to baseline | Change of fecal and serum metabolome |
| Gut microbiome | After 8 weeks compared to placebo and adjusted to baseline | Change of fecal microbiome composition |
| PROMIS-29 domain depression | After 8 weeks compared to placebo and adjusted to baseline | Lower (better) T-score (mean 50, SD 10) |
| PROMIS-29 domain anxiety | After 8 weeks compared to placebo and adjusted to baseline | Lower (better) T-score (mean 50, SD 10) |
| PROMIS-29 domain physical function | After 8 weeks compared to placebo and adjusted to baseline | Higher (better) T-score (mean 50, SD 10) |
| PROMIS-29 domain fatigue | After 8 weeks compared to placebo and adjusted to baseline | Lower (better) T-score (mean 50, SD 10) |
| PROMIS-29 domain sleep disturbance | After 8 weeks compared to placebo and adjusted to baseline | Lower (better) T-score (mean 50, SD 10) |
| PROMIS-29 domain ability to participate in social roles and activities | After 8 weeks compared to placebo and adjusted to baseline | Higher (better) T-score (mean 50, SD 10) |
| Glucose variability after standardized breakfasts | After 8 weeks compared to placebo and adjusted to baseline | Measured by continuous glucose monitoring |
Countries
Germany
Outcome results
None listed