Condition category
Circulatory System
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
High blood pressure (hypertension) is a major cardiovascular (heart disease) risk factor. It has been shown that reducing blood pressure reduces the risk of cardiovascular diseases and stroke. For people with high-normal blood pressure and without any serious risk factors like diabetes and kidney failure clinical treatment using medications is not indicated, but changes in lifestyle and diet could be helpful. The purpose of this study is to assess the safety of a probiotic Edam-type cheese and its effectiveness on blood pressure reduction.

Who can participate?
Generally healthy persons aged 18 years and over with elevated blood pressure who do not take medications will be recruited through clinics in Southern and Central Estonia.

What does the study involve?
Participants are randomly allocated to eat 50 g per day of either probiotic cheese or normal cheese, or to receive no treatment. The study duration is 4 weeks, and participants are asked to assess their well-being and gastrointestinal (digestive) effects, and also to provide blood, urine and fecal samples to test the effects of the probiotic.

What are the possible benefits and risks of participating?
Study participants will receive an assessment of their health status and if necessary, a consultation with a nutritionist and/or a specialist. The study causes minimal inconvenience to participants. As blood samples are taken by an experienced nurse, the procedure is safe. However, there may be bruising and discomfort at the site of the blood test as with any blood test. The amounts of blood we are taking are small enough that they should not make you feel fatigue or cause anemia. There may be local red reactions at the site of the injections.

Where is the study run from?
The study is carried out in a cooperation between the Bio-Competence Centre of Healthy Dairy Products LLC, the Faculty of Medicine, University of Tartu and the Dairy Cooperative E-piim (Estonia). The study takes place at the Centre for Clinical and Physiological Research of the Bio-Competence Centre of Healthy Dairy Products LLC in Tartu, Estonia.

When is the study starting and how long is it expected to run for?
Patients will be enrolled in the study in September 2011. Follow-up examinations will continue until December 2011.

Who is funding the study?
Bio-Competence Centre of Healthy Dairy Products LLC, the EU Structural Funds.

Who is the main contact?
Dr Pirje Hütt

Trial website

Contact information



Primary contact

Prof Marika Mikelsaar


Contact details

University of Tartu
Faculty of Medicine
Dept of Microbiology
Ravila 19
+372 (0)737 4179

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Effect of the probiotic Südamejuust (heart friendly cheese) comprising Lactobacillus plantarum TENSIA DSM 21380 on subjects with high-normal blood pressure: a randomized blinded controlled parallel three-arm study



Study hypothesis

The consumption of probiotic cheese comprising the strain L. plantarum TENSIA helps to maintain normal blood pressure by reducing high-normal systolic and/or diastolic blood pressure.

Ethics approval

Ethics Review Committee on Human Research of the University of Tartu, 14/03/2011, ref: 205T-5

Study design

Randomized blinded controlled parallel three-arm study

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type


Patient information sheet

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




Participants randomised to active, placebo or control group will receive the intervention for 3 weeks:
1. Active intervention: probiotics cheese 50 g per day (probiotic Lactobacillus plantarum
TENSIA dose: 10^10 colony forming units [CFU])
2. Placebo: 50 g control cheese
3. Control: no treatment

Intervention type



Phase II

Drug names

Lactobacillus plantarum TENSIA probiotic cheese

Primary outcome measure

Decrease in systolic and/or diastolic blood pressure measured pre intervention, at the end of the intervention and also 1 week post intervention.

Secondary outcome measures

The following outcomes will be measured pre intervention, at the end of the intervention and also 1 week post intervention.
1. Body mass index (BMI)
2. Changes in inflammatory markers (WBC, hs-CRP)
3. Changes in lipidogram [total cholesterol and/or low density lipoprotein (LDL)-cholesterol and/or triglycerides]
4. Changes in fecal microflora
5. Persistence of ingested probiotic strain for 1 week
6. Blood, fecal and urine samples are collected at run-in, baseline and end of the study

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Wish to participate
2. Aged 18 years and over
3. Baseline blood pressure levels high-normal according to European Society of Hypertension (ESH)/European Society of Cardiology (ESC) Guidelines for the Management of Arterial Hypertension (2007): systolic blood pressure (SBP) 130-139 mmHg, diastolic blood pressure (DBP) 85-89 mmHg, white blood cell (WBC) < 8.8x109 /L, high sensitivity C-reactive protein (hs-CRP) < 5 mg/L, glucose <6.0 mmol/L, serum creatinine F < 80 µmol/L, M: <106 µmol/L.
4. Signed informed consent

Participant type


Age group




Target number of participants

120, 40 subjects in each arm

Participant exclusion criteria

1. History of any gastrointestinal disease
2. Use of any antimicrobial drug within the last month
3. Use of any regular concomitant medication, including medical preparations including non-steroidal anti-inflammatory drugs and antioxidant vitamins
4. Food allergy
5. Diabetes and acute infection
6. Pregnancy or breastfeeding

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

University of Tartu

Sponsor information


Bio-Competence Centre of Healthy Dairy Products LLC (Estonia)

Sponsor details

Kreutzwaldi 1
+372 (0)516 4210

Sponsor type





Funder type


Funder name

Bio-Competence Centre of Healthy Dairy Products LLC (Estonia)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes