Condition category
Circulatory System
Date applied
09/08/2011
Date assigned
24/08/2011
Last edited
10/09/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
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
pirje.hutt@ut.ee

Trial website

Contact information

Type

Scientific

Primary contact

Prof Marika Mikelsaar

ORCID ID

Contact details

University of Tartu
Faculty of Medicine
Dept of Microbiology
Ravila 19
Tartu
50411
Estonia
+372 (0)737 4179
marika.mikelsaar@ut.ee

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

202M-25

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

Acronym

TE6

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

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

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

Condition

Hypertension

Intervention

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

Drug

Phase

Phase II

Drug names

Lactobacillus plantarum TENSIA probiotic cheese

Primary outcome measures

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

19/09/2011

Overall trial end date

07/11/2011

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Both

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

19/09/2011

Recruitment end date

07/11/2011

Locations

Countries of recruitment

Estonia

Trial participating centre

University of Tartu
Tartu
50411
Estonia

Sponsor information

Organisation

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

Sponsor details

Kreutzwaldi 1
Tartu
51014
Estonia
+372 (0)516 4210
ene.tammsaar@tptak.ee

Sponsor type

Industry

Website

http:// www.tptak.ee

Funders

Funder type

Industry

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes