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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Active Comparator | Two sachets Vivomixx® containing 8 strains of life bacteria (9 x 10^11 CFU) in the evening for 8 weeks |
|
| Placebo | Placebo Comparator | Two sachets placebo in the evening for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vivomixx® | Dietary Supplement | Microbiotic food supplement with L. paracasei, L. plantarum, L. acidophilus, L. delbrueckii, B. longum, B. infantis, B. breve, S. thermophilus |
|
| Measure | Description | Time Frame |
|---|---|---|
| Nocturnal systolic blood pressure | Measured by 24h ABPM (mmHg) | After 8 weeks compared to placebo and adjusted to baseline |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
Comments:
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| Name | Affiliation | Role |
|---|---|---|
| Anja Mähler, PhD | Charite University, Berlin, Germany | Principal Investigator |
| Dominik N. Müller, PhD | Max Delbruck Center (MDC) | Principal Investigator |
| Ralf Dechend, MD | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Experimental and Clinical Research Center | Berlin | 13125 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33375942 | Background | 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. |
| Label | URL |
|---|---|
| Protocol publication | View source |
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Individual participant data that underlie the results of reported articles (text, tables, figures, supplemental data) will be shared after deidentification.
Beginning 9 months and ending 36 months following article publication.
Researchers who provide a methodologically sound proposal.
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Placebo | Other | Placebo with similar appearance to probiotic |
|
| 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 |