Effect of the probiotic strain TENSIA® DSM21380 on high-normal blood pressure and up to grade-1 hypertensio

Recruiting

• Conditions: Prehypertension; Circulatory System

• Registration Number: ISRCTN51761666
• Lead Sponsor: BioCC LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-11
• Last Update Posted: 2 July 2018
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Written informed consent
2. Age over 30 years
3. Willingness to maintain a stable diet and physical activity level
4. Normal or not clinically relevant deviations in safety laboratory values
5. High normal or grade 1 systolic/diastolic blood pressure (=159/99 mm Hg) with up to medium added risks in coronary-heart diseases
6. No use of any concomitant treatment (including blood pressure lowering drugs e.g. ACE-inhibitors, blockers of beta adrenergic receptors, calcium channel blockers and diuretics) and lipid lowering drugs (e.g. statins, bile acid sequestrates, cholesterol absorption inhibitors, nicotinic acid)

Exclusion Criteria

1. Pregnancy and breastfeeding
2. (Food) allergy
3. Intolerance to the investigational product / its ingredients
4. Diabetes
5. Eating disorder
6. Active weight loss > 5 kg in prior 3 months
7. Extensive exercise (daily trainings of professional athletes)
8. Drug or alcohol abuse
9. Participation in other studies within the last 30 days / during the study
10. Any history of gastrointestinal diseases
11. Acute infection within the last 2 weeks prior to baseline
12. Use of any antimicrobial agents within the preceding 1 month
13. Donor within the last 1,5 months prior to start of the study (i.e. baseline visit)
14. Use of any pre-, probiotic or food supplement within the last 2 weeks prior to start of the study
15. Chronic inflammatory diseases

Study & Design

• Study Type: Interventional
• Study Design: Not specified