Effect of the probiotic strain TENSIA® DSM21380 on high-normal blood pressure and up to grade-1 hypertension
| ISRCTN | ISRCTN51761666 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51761666 |
| Secondary identifying numbers | TC17-20 |
- Submission date
- 26/02/2018
- Registration date
- 11/06/2018
- Last edited
- 11/06/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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 dietary supplement on blood pressure.
Who can participate?
Generally healthy people aged over 30 years with elevated blood pressure, who do not take blood pressure lowering medication
What does the study involve?
Participants are randomly allocated to take either a probiotic or a placebo (dummy) capsule once a day for 8 weeks. Participants are asked to assess their well-being and gastrointestinal (digestive) effects, and also to provide blood, urine and faecal samples to test the effect of the probiotic and treatment compliance.
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 clinician. 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. Collected blood amounts are small enough not to cause fatigue.
Where is the study run from?
BioCC LLC (Estonia)
When is the study starting and how long is it expected to run for?
Investigator initiated and funded
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Merle Rätsep
merle.ratsep@biocc.eu
Contact information
Scientific
Riia 181A
Tartu
51014
Estonia
Study information
| Study design | Interventional multicentre randomised placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Effect of a dietary supplement containing L. plantarum TENSIA® DSM21380 on subjects with high-normal blood pressure up to grade-1 hypertension: a randomised blinded placebo-controlled parallel designed two-armed study |
| Study acronym | TC |
| Study objectives | The consumption of a dietary supplement containing L. plantarum TENSIA® DSM21380 has a beneficial effect on the blood pressure of subjects with high-normal blood pressure up to grade-1 hypertension. |
| Ethics approval(s) | Research Ethics Committee of the University of Tartu, 20/09/2017, ref: 272/T-15 |
| Health condition(s) or problem(s) studied | Prehypertension |
| Intervention | Participants are randomly allocated to either the intervention group or the placebo group applying a 1:1 allocation ratio: Group 1 (verum): Participants take one capsule daily for eight weeks. The capsule contains a daily dose of product containing 2x10e10 cfu of L. plantarum TENSIA®. Group 2 (placebo): Participants take one capsule daily for eight weeks. The capsule contains a daily dose of product containing no active compounds (microcellulose). Participants take the product daily for eight weeks and the last study visit will be performed two weeks after the end of the treatment. |
| Intervention type | Supplement |
| Primary outcome measure | Change in systolic blood pressure (SBP) measured with a mercury sphygmomanometer at 8 weeks from baseline |
| Secondary outcome measures | 1. Changes in SBP measured with a mercury sphygmomanometer at 4 weeks from baseline level and at 8 weeks from level at 4 weeks 2. Changes in diastolic blood pressure measured with a mercury sphygmomanometer at 8 weeks from baseline level, at 4 weeks from baseline level and at 8 weeks from level at 4 weeks Changes at 8 weeks from baseline and at 4 weeks from baseline in the following outcome measures: 3. Oxidative stress indices and renin-angiotensin-aldosterone system (RAAS) indices measured from blood and urine samples using different ELISA based assays 4. Short chain fatty acids (SCFA) measured from stool samples using High Pressure Liquid Chromatography (HPLC) 5. Gut microflora indices (lactoflora, anaerobes etc) measured from stool samples using molecular approaches and specific primers |
| Overall study start date | 03/10/2017 |
| Completion date | 30/12/2020 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 200 (100 subjects in both groups) |
| Key inclusion criteria | 1. Written informed consent 2. Age over 30 years 3. Willingness to maintain a stable diet and physical activity level 4. Normal or not clinically relevant deviations in safety laboratory values 5. High normal or grade 1 systolic/diastolic blood pressure (≤159/99 mm Hg) with up to medium added risks in coronary-heart diseases 6. No use of any concomitant treatment (including blood pressure lowering drugs e.g. ACE-inhibitors, blockers of beta adrenergic receptors, calcium channel blockers and diuretics) and lipid lowering drugs (e.g. statins, bile acid sequestrates, cholesterol absorption inhibitors, nicotinic acid) |
| Key exclusion criteria | 1. Pregnancy and breastfeeding 2. (Food) allergy 3. Intolerance to the investigational product / its ingredients 4. Diabetes 5. Eating disorder 6. Active weight loss > 5 kg in prior 3 months 7. Extensive exercise (daily trainings of professional athletes) 8. Drug or alcohol abuse 9. Participation in other studies within the last 30 days / during the study 10. Any history of gastrointestinal diseases 11. Acute infection within the last 2 weeks prior to baseline 12. Use of any antimicrobial agents within the preceding 1 month 13. Donor within the last 1,5 months prior to start of the study (i.e. baseline visit) 14. Use of any pre-, probiotic or food supplement within the last 2 weeks prior to start of the study 15. Chronic inflammatory diseases |
| Date of first enrolment | 03/10/2017 |
| Date of final enrolment | 01/10/2020 |
Locations
Countries of recruitment
- Estonia
Study participating centre
Tartu
51014
Estonia
Sponsor information
Research organisation
Kreutzwaldi 1
Tartu
51014
Estonia
| Website | www.biocc.eu |
|---|---|
"ROR" |
https://ror.org/02e801388 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 30/12/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The current data sharing plans for the current study are unknown and will be made available at a later date. |
