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Active, Not Recruiting

NCT Number: NCT03906578

Effects of a Probiotic in Hypertension

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Experimental and Clinical Research Center

Berlin, 13125, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vivomixx®

Dietary Supplement

Microbiotic food supplement with L. paracasei, L. plantarum, L. acidophilus, L. delbrueckii, B. longum, B. infantis, B. breve, S. thermophilus

Placebo

Other

Placebo with similar appearance to probiotic

Primary outcomes

  1. Nocturnal systolic blood pressure

    Time frame: After 8 weeks compared to placebo and adjusted to baseline

    Measured by 24h ABPM (mmHg)

Secondary outcomes

  1. Nocturnal diastolic blood pressure

    Time frame: After 8 weeks compared to placebo and adjusted to baseline

    Measured by 24h ABPM (mmHg)

  2. 24h systolic blood pressure

    Time frame: After 8 weeks compared to placebo and adjusted to baseline

    Measured by 24h ABPM (mmHg)

  3. 24h diastolic blood pressure

    Time frame: After 8 weeks compared to placebo and adjusted to baseline

    Measured by 24h ABPM (mmHg)

  4. Office systolic blood pressure

    Time frame: After 8 weeks compared to placebo and adjusted to baseline

    Mean of five consecutive blood pressure measurements (mmHg)

  5. Office diastolic blood pressure

    Time frame: After 8 weeks compared to placebo and adjusted to baseline

    Mean of five consecutive blood pressure measurements (mmHg)

  6. Reduction of antihypertensive medication

    Time frame: After 8 weeks compared to placebo and adjusted to baseline

    Number and dosage of prescribed medication

  7. Glucose variability after standardized breakfasts

    Time frame: After 8 weeks compared to placebo and adjusted to baseline

    Measured by continuous glucose monitoring

  8. Gut microbiome

    Time frame: After 8 weeks compared to placebo and adjusted to baseline

    Change of fecal microbiome composition

  9. Metabolomics stool and serum

    Time frame: After 8 weeks compared to placebo and adjusted to baseline

    Change of fecal and serum metabolome

  10. Change in immune cell phenotypes

    Time frame: After 8 weeks compared to placebo and adjusted to baseline

    Peripheral blood effector T cell frequencies (%)

  11. PROMIS-29 domain pain interference

    Time frame: After 8 weeks compared to placebo and adjusted to baseline

    Range 0-10 with 0 indicating no pain

  12. PROMIS-29 domain depression

    Time frame: After 8 weeks compared to placebo and adjusted to baseline

    Lower (better) T-score (mean 50, SD 10)

  13. PROMIS-29 domain anxiety

    Time frame: After 8 weeks compared to placebo and adjusted to baseline

    Lower (better) T-score (mean 50, SD 10)

  14. PROMIS-29 domain physical function

    Time frame: After 8 weeks compared to placebo and adjusted to baseline

    Higher (better) T-score (mean 50, SD 10)

  15. PROMIS-29 domain fatigue

    Time frame: After 8 weeks compared to placebo and adjusted to baseline

    Lower (better) T-score (mean 50, SD 10)

  16. PROMIS-29 domain sleep disturbance

    Time frame: After 8 weeks compared to placebo and adjusted to baseline

    Lower (better) T-score (mean 50, SD 10)

  17. PROMIS-29 domain ability to participate in social roles and activities

    Time frame: After 8 weeks compared to placebo and adjusted to baseline

    Higher (better) T-score (mean 50, SD 10)

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Acronym: HYPRO

Important dates

Study start
2019
Primary completion
2024
Study completion
2025
First posted
Apr 8, 2019
Registry last updated
Jul 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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