Effects of a Probiotic in Hypertension

Hypertension Clinical Trial

— HYPRO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03906578
• Other study ID #: HYPRO
• Status: Recruiting
• Phase: N/A
• Start date: September 2, 2019
• Est. completion date: September 1, 2025

Study information

• Verified date: February 2024
• Source: Charite University, Berlin, Germany
• Contact: Anja Mähler, PhD
• Phone: +49 30 450 540 323
• Email: anja.maehler[@]charite.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Dietary Supplement:
• Vivomixx®
Microbiotic food supplement with L. paracasei, L. plantarum, L. acidophilus, L. delbrueckii, B. longum, B. infantis, B. breve, S. thermophilus

Other:
• Placebo
Placebo with similar appearance to probiotic

Locations

Country	Name	City	State
Germany	Experimental and Clinical Research Center	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nocturnal systolic blood pressure	Measured by 24h ABPM (mmHg)	After 8 weeks compared to placebo and adjusted to baseline
Secondary	Nocturnal diastolic blood pressure	Measured by 24h ABPM (mmHg)	After 8 weeks compared to placebo and adjusted to baseline
Secondary	24h systolic blood pressure	Measured by 24h ABPM (mmHg)	After 8 weeks compared to placebo and adjusted to baseline
Secondary	24h diastolic blood pressure	Measured by 24h ABPM (mmHg)	After 8 weeks compared to placebo and adjusted to baseline
Secondary	Office systolic blood pressure	Mean of five consecutive blood pressure measurements (mmHg)	After 8 weeks compared to placebo and adjusted to baseline
Secondary	Office diastolic blood pressure	Mean of five consecutive blood pressure measurements (mmHg)	After 8 weeks compared to placebo and adjusted to baseline
Secondary	Reduction of antihypertensive medication	Number and dosage of prescribed medication	After 8 weeks compared to placebo and adjusted to baseline
Secondary	Glucose variability after standardized breakfasts	Measured by continuous glucose monitoring	After 8 weeks compared to placebo and adjusted to baseline
Secondary	Gut microbiome	Change of fecal microbiome composition	After 8 weeks compared to placebo and adjusted to baseline
Secondary	Metabolomics stool and serum	Change of fecal and serum metabolome	After 8 weeks compared to placebo and adjusted to baseline
Secondary	Change in immune cell phenotypes	Peripheral blood effector T cell frequencies (%)	After 8 weeks compared to placebo and adjusted to baseline
Secondary	PROMIS-29 domain pain interference	Range 0-10 with 0 indicating no pain	After 8 weeks compared to placebo and adjusted to baseline
Secondary	PROMIS-29 domain depression	Lower (better) T-score (mean 50, SD 10)	After 8 weeks compared to placebo and adjusted to baseline
Secondary	PROMIS-29 domain anxiety	Lower (better) T-score (mean 50, SD 10)	After 8 weeks compared to placebo and adjusted to baseline
Secondary	PROMIS-29 domain physical function	Higher (better) T-score (mean 50, SD 10)	After 8 weeks compared to placebo and adjusted to baseline
Secondary	PROMIS-29 domain fatigue	Lower (better) T-score (mean 50, SD 10)	After 8 weeks compared to placebo and adjusted to baseline
Secondary	PROMIS-29 domain sleep disturbance	Lower (better) T-score (mean 50, SD 10)	After 8 weeks compared to placebo and adjusted to baseline
Secondary	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

External Links

•   Protocol publication