Effects of a Probiotic in Hypertension

Not Applicable

Active, not recruiting

• Conditions: Hypertension
• Interventions: Dietary Supplement: Vivomixx®; Other: Placebo

• Registration Number: NCT03906578
• Lead Sponsor: Charite University, Berlin, Germany

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-05
• Study First Submitted QC: 2019-04-05
• Study First Posted: 2019-04-08
• Study Start: 2019-09-02
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-08
• Last Update Posted: 2024-07-09
• Primary Completion: 2024-09-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic	Vivomixx®	Two sachets Vivomixx® containing 8 strains of life bacteria (9 x 10\^11 CFU) in the evening for 8 weeks
Placebo	Placebo	Two sachets placebo in the evening for 8 weeks

Primary Outcome Measures

Name	Time	Method
Nocturnal systolic blood pressure	After 8 weeks compared to placebo and adjusted to baseline	Measured by 24h ABPM (mmHg)

Secondary Outcome Measures

Name	Time	Method
Office systolic blood pressure	After 8 weeks compared to placebo and adjusted to baseline	Mean of five consecutive blood pressure measurements (mmHg)
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)
Change in immune cell phenotypes	After 8 weeks compared to placebo and adjusted to baseline	Peripheral blood effector T cell frequencies (%)
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 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)
Office diastolic blood pressure	After 8 weeks compared to placebo and adjusted to baseline	Mean of five consecutive blood pressure measurements (mmHg)
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)
Reduction of antihypertensive medication	After 8 weeks compared to placebo and adjusted to baseline	Number and dosage of prescribed medication
Glucose variability after standardized breakfasts	After 8 weeks compared to placebo and adjusted to baseline	Measured by continuous glucose monitoring
Metabolomics stool and serum	After 8 weeks compared to placebo and adjusted to baseline	Change of fecal and serum metabolome
PROMIS-29 domain pain interference	After 8 weeks compared to placebo and adjusted to baseline	Range 0-10 with 0 indicating no pain
PROMIS-29 domain sleep disturbance	After 8 weeks compared to placebo and adjusted to baseline	Lower (better) T-score (mean 50, SD 10)

Trial Locations

Locations (1)

Experimental and Clinical Research Center; 🇩🇪 Berlin, Germany