Effect of the probiotic cheese on high-normal blood pressure
| ISRCTN | ISRCTN29105501 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29105501 |
| Secondary identifying numbers | 202M-25 |
- Submission date
- 29/10/2012
- Registration date
- 15/11/2012
- Last edited
- 07/02/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
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 Edam-type cheese on blood pressure reduction.
Who can participate?
Generally healthy people aged 18 and over with elevated blood pressure, who do not take medication
What does the study involve?
Participants are randomly allocated to eat 50 g per day of either probiotic cheese or normal cheese. 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 effect of the probiotic.
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 specialist. 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. The amounts of blood we are taking are small enough that they should not make you feel fatigue or cause anemia.
Where is the study run from?
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?
March to December 2012
Who is funding the study?
EU Structural Funds
Who is the main contact?
Dr Pirje Hütt
pirje.hutt@ut.ee
Contact information
Scientific
Kreutzwaldi 1
Tartu
51014
Estonia
| esongisepp@gmail.com |
Study information
| Study design | Randomized double-blind controlled parallel-designed two-armed intervention trial |
|---|---|
| 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 (cheese) comprising Lactobacillus plantarum TENSIA DSM 21380 on subjects with high-normal blood pressure: a randomized blinded controlled parallel designed two armed study |
| Study hypothesis | The consumption of probiotic cheese helps to maintain the normal blood pressure by reducing high-normal systolic and/or diastolic blood pressure. |
| Ethics approval(s) | Human Research Ethics Review Committee, University of Tartu, 14/03/2011, ref: 202M-25 |
| Condition | Prehypertension |
| Intervention | Participants randomised to active or control group will be required during 4+4 weeks: 1. Active intervention: probiotics cheese 50g per day (probiotic Lactobacillus plantarum TENSIA daily dose: 10^10 colony forming units [CFU]) 2. Control: 50 g control cheese without probiotic additive |
| Intervention type | Other |
| Primary outcome measure | (Systolic) blood pressure, measured pre intervention, after 4 weeks and at the end of the intervention |
| Secondary outcome measures | 1. Reduction in DBP 2. Differences between verum and placebo in DBP values 3. Difference between verum and placebo in blood pressure values for the period 5 -8 weeks of product intake (by comparison of levels after 8 weeks with the levels after 4 weeks) 4. Samples are collected at run-in, baseline, after 4 weeks and at the end Measured pre intervention, after 4 weeks and at the end of the intervention |
| Overall study start date | 01/03/2012 |
| Overall study end date | 31/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 150 (75 subjects in each arm) |
| Participant inclusion criteria | 1. Wish to participate 2. Male and female subjects aged between 18 - 65 years with a body weight between 50 and 100 kg and a body mass index between 1829.9 kg/m2 3. High normal (130 - 139 / 85 - 89 mmHg) or hypertension grade 1 (140 - 159/90 - 99 mmHg) baseline blood pressure (BP) levels, as defined by ESH/ESC guidelines 4. Normal or not clinically significant deviations in safety laboratory values (clinical chemistry, blood count), WBC <8.8x 109/L, hs-CRP <5 mg/L; fasting glucose <6.0mmol/L, serum creatinine females <80 μmol/L, serum creatinine males <106 μmol/L, HbA1c < 6.5% 5. No use of any concomitant treatment which could influence the evaluation of the efficacy and tolerability of the investigational study product within one month prior to study start, including: 5.1. Supplementation with e.g. omega-3 fatty acids, omega-6 fatty acids, potassium, garlic, gingko biloba, polyphenols (e.g. quercetin), calcium, niacin, soy protein, green tea extract, oat fibre, plant sterols, psyllium seed husk or probiotics/probiotics 5.2. Intake of high amounts of walnuts 6. Signed informed consent |
| Participant exclusion criteria | 1. History of any gastrointestinal disease 2. Use of any antimicrobial drug within 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 7. SBP ≤ 129 mmHg and/or DBP ≤ 84 mmHg 7.1. Hypertension grade > 1 as defined by a SBP ≥160 mmHg and/or DBP ≥100 mmHg 7.2. History (e.g. stroke) or clinical signs of cardiovascular abnormalities, in particular cardiac arrhythmia and bradycardia (pulse rate <50 beats per minute) |
| Recruitment start date | 01/03/2012 |
| Recruitment end date | 31/12/2012 |
Locations
Countries of recruitment
- Estonia
Study participating centre
51014
Estonia
Sponsor information
Research organisation
Kreutzwaldi 1
Tartu
51014
Estonia
| merlera@ut.ee | |
| Website | https://www.tptak.ee |
Funders
Funder type
Government
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"
12/09/2016: Plain English summary added.
