Effect of the probiotic cheese on high-normal blood pressure
| ISRCTN | ISRCTN29040130 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29040130 |
| Secondary identifying numbers | 202M-25 |
- Submission date
- 09/08/2011
- Registration date
- 24/08/2011
- Last edited
- 07/02/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Scientific
University of Tartu
Faculty of Medicine
Dept of Microbiology
Ravila 19
Tartu
50411
Estonia
| Phone | +372 (0)737 4179 |
|---|---|
| marika.mikelsaar@ut.ee |
Study information
| Study design | Randomized blinded controlled parallel three-arm study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 acronym | TE6 |
| Study objectives | 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(s) | Ethics Review Committee on Human Research of the University of Tartu, 14/03/2011, ref: 205T-5 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | 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 study start date | 19/09/2011 |
| Completion date | 07/11/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 120, 40 subjects in each arm |
| Key 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 |
| Key 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 |
| Date of first enrolment | 19/09/2011 |
| Date of final enrolment | 07/11/2011 |
Locations
Countries of recruitment
- Estonia
Study participating centre
50411
Estonia
Sponsor information
Industry
Kreutzwaldi 1
Tartu
51014
Estonia
| Phone | +372 (0)516 4210 |
|---|---|
| ene.tammsaar@tptak.ee | |
| Website | http:// www.tptak.ee |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Editorial Notes
07/02/2022: The sponsor organisation has been changed from "Bio-Competence Centre of Healthy Dairy Products LLC (Estonia)" to "BioCC OÜ".
