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

• Register: ISRCTN
• Last refreshed on: 2 July 2018
• Main ID: ISRCTN51761666
• Date of registration: 11/06/2018
• Prospective Registration: No
• Primary sponsor: BioCC LLC
• Public title: Effect of the probiotic strain TENSIA® DSM21380 on high-normal blood pressure and up to grade-1 hypertension
• Scientific title: Effect of a dietary supplement containing L. plantarum TENSIA® DSM21380 on subjects with high-normal blood pressure up to grade-1 hypertension: a randomised blinded placebo-controlled parallel designed two-armed study
• Date of first enrolment: 03/10/2017
• Target sample size: 200
• Recruitment status: Recruiting
• URL: http://isrctn.com/ISRCTN51761666
• Study type: Interventional
• Study design: Interventional multicentre randomised placebo-controlled trial (Prevention)

Countries of recruitment

Estonia

Contacts

• Name: Merle Rätsep

Key inclusion & exclusion criteria

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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Prehypertension
Circulatory System

Intervention(s)

Participants are randomly allocated to either the intervention group or the placebo group applying a 1:1 allocation ratio:
Group 1 (verum): Participants take one capsule daily for eight weeks. The capsule contains a daily dose of product containing 2x10e10 cfu of L. plantarum TENSIA®.
Group 2 (placebo): Participants take one capsule daily for eight weeks. The capsule contains a daily dose of product containing no active compounds (microcellulose).
Participants take the product daily for eight weeks and the last study visit will be performed two weeks after the end of the treatment.

Primary Outcome(s)

Change in systolic blood pressure (SBP) measured with a mercury sphygmomanometer at 8 weeks from baseline

Secondary Outcome(s)

1. Changes in SBP measured with a mercury sphygmomanometer at 4 weeks from baseline level and at 8 weeks from level at 4 weeks
2. Changes in diastolic blood pressure measured with a mercury sphygmomanometer at 8 weeks from baseline level, at 4 weeks from baseline level and at 8 weeks from level at 4 weeks
Changes at 8 weeks from baseline and at 4 weeks from baseline in the following outcome measures:
3. Oxidative stress indices and renin-angiotensin-aldosterone system (RAAS) indices measured from blood and urine samples using different ELISA based assays
4. Short chain fatty acids (SCFA) measured from stool samples using High Pressure Liquid Chromatography (HPLC)
5. Gut microflora indices (lactoflora, anaerobes etc) measured from stool samples using molecular approaches and specific primers

Secondary ID(s)

TC17-20

Source(s) of Monetary Support

Investigator initiated and funded

Ethics review

Status:
Approval date:
Contact:

Research Ethics Committee of the University of Tartu, 20/09/2017, ref: 272/T-15

Results

• Date Completed: 30/12/2020