Condition category
Circulatory System
Date applied
26/02/2018
Date assigned
11/06/2018
Last edited
11/06/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Having high blood pressure (hypertension) increases the risk of serious problems such as heart attacks and strokes. Reducing blood pressure reduces the risk of heart disease and stroke. Lifestyle and diet changes are helpful for people whose blood pressure is higher than normal but not high enough to require drug treatment. The aim of this study is to assess the effect of a probiotic dietary supplement on blood pressure.

Who can participate?
Generally healthy people aged over 30 years with elevated blood pressure, who do not take blood pressure lowering medication

What does the study involve?
Participants are randomly allocated to take either a probiotic or a placebo (dummy) capsule once a day for 8 weeks. Participants are asked to assess their well-being and gastrointestinal (digestive) effects, and also to provide blood, urine and faecal samples to test the effect of the probiotic and treatment compliance.

What are the possible benefits and risks of participating?
Participants receive an assessment of their health status and if necessary, a free consultation with a nutritionist and/or a clinician. The study causes minimal inconvenience to participants. As blood samples are taken by an experienced nurse, the procedure is safe. However, as with any blood test, there may be bruising and discomfort at the site of the blood test. Collected blood amounts are small enough not to cause fatigue.

Where is the study run from?
BioCC LLC (Estonia)

When is the study starting and how long is it expected to run for?
Investigator initiated and funded

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Merle Rätsep
merle.ratsep@biocc.eu

Trial website

Contact information

Type

Scientific

Primary contact

Miss Merle Rätsep

ORCID ID

Contact details

Riia 181A
Tartu
51014
Estonia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

TC17-20

Study information

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

Acronym

TC

Study hypothesis

The consumption of a dietary supplement containing L. plantarum TENSIA® DSM21380 has a beneficial effect on the blood pressure of subjects with high-normal blood pressure up to grade-1 hypertension.

Ethics approval

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

Study design

Interventional multicentre randomised placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Prehypertension

Intervention

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.

Intervention type

Supplement

Phase

Drug names

Primary outcome measure

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

Secondary outcome measures

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

Overall trial start date

03/10/2017

Overall trial end date

30/12/2020

Reason abandoned (if study stopped)

Eligibility

Participant 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)

Participant type

Other

Age group

Adult

Gender

Both

Target number of participants

200 (100 subjects in both groups)

Participant 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

Recruitment start date

03/10/2017

Recruitment end date

01/10/2020

Locations

Countries of recruitment

Estonia

Trial participating centre

BioCC LLC
Riia 181A
Tartu
51014
Estonia

Sponsor information

Organisation

BioCC LLC

Sponsor details

Kreutzwaldi 1
Tartu
51014
Estonia

Sponsor type

Research organisation

Website

www.biocc.eu

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

30/12/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes