Study Description

Einfluss eines Probiotikums auf Bluthochdruck

HYPRO

Bluthochdruck ist einer der wichtigsten Risikofaktoren für Herz-Kreislauf-Erkrankungen wie die koronare Herzkrankheit, Herzversagen, Nierenerkrankungen und Schlaganfälle. Trotz einer Vielzahl von Medikamenten liegt nur etwa bei der Hälfte der Behandelten der Blutdruck im empfohlenen Bereich. In einer von uns durchgeführten Pilotstudie ergaben sich Hinweise dafür, dass ein Probiotikum aus 8 lebensfähigen Bakterienstämmen den salzsensitiven Blutdruckanstieg in gesunden Männern verhindern kann. Deshalb untersuchen wir jetzt in einer randomisierten, placebokontrollierten Studie, inwieweit dieses Probiotikum den Blutdruck, das Darm-Mikrobiom, das Immunsystem, den Glucose-Stoffwechsel und die gesundheitsbezogene Lebensqualität von Männern und Frauen mit Bluthochdruck Grad 1 beeinflusst.

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.

• https://www.mdc-berlin.de/de/cru#t-probanden/patienten

ClinicalTrials.gov-No. (NCT)

NCT03906578

02.09.2019

31.12.2023

Investigated Disease, Health Issue

• I10 - Essentielle (primäre) Hypertonie

Low-to-moderate Risk Grade 1 Hypertension

Inclusion Criteria

50 - 80

All

• Men and postmenopausal women (50-75 years)
• Treated or untreated grade 1 hypertension (resting office blood pressure >140/90 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

Characteristics

Interventional

N/A

1. Nocturnal systolic blood pressure
Measured by 24h ABPM (mmHg)
[Time Frame: After 8 weeks compared to placebo and adjusted to baseline]

2. Nocturnal diastolic blood pressure
3. 24h systolic blood pressure
4. 24h diastolic blood pressure
5. Office systolic blood pressure
6. Office diastolic blood pressure
Mean of five consecutive blood pressure measurements (mmHg)
7. Reduction of antihypertensive medication
8. Glucose variability after standardized breakfasts
9. Gut microbiome
Change of fecal microbiome composition
10. Metabolomics stool and serum
Change of fecal and serum metabolome
11. Change in immune cell phenotypes
Peripheral blood effector T cell frequencies (%)
12. PROMIS-29 domain pain interference
13. PROMIS-29 domain depression
14. PROMIS-29 domain anxiety
15. PROMIS-29 domain physical function
16. PROMIS-29 domain fatigue
17. PROMIS-29 domain sleep disturbance
18. PROMIS-29 domain ability to participate in social roles and activities

Intervention Groups, Observation Groups

• Arm 1

  Active Comparator: Probiotic
  Two sachets Vivomixx® containing 8 strains of life bacteria (9 x 10^11 CFU) in the evening for 8 weeks

• Arm 2

  Placebo Comparator: Placebo
  Two sachets placebo in the evening for 8 weeks

Contact

Frau Gabriele Rahn

030 450 540 234

leaner(at)charite.de

Frau Dr.rer. medic. Anja Mähler

030 450 540 323

anja.maehler(at)charite.de

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