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
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