Blood PressureNCT01989702
Effect of a Probiotic-based Product on Blood Pressure
A study testing Fermented blueberry drink and Sachets with probiotic bacterial powder in people with Blood Pressure, run by Probi AB at 1 site in Sweden.
Trial summary
The aim of the present study was to examine the efficacy of a probiotic-based product on either reducing hypertension or preventing a high normal blood pressure from reaching hypertensive levels. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Fermented blueberry drink and Sachets with probiotic bacterial powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2010to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy individuals at the age of 40-75 years.
- Blood-pressure >140/90 mmHg that has been confirmed at 2-3 separate occasions or represents the mean value of a 24-hour measurement.
- Triglycerides >1,7 mmol/L and/or HDL <1 mmol/L (men)/1,29 mmol/L (women).
- Fasting plasma glucose levels >5,6 mmol/L and/or waist circumference >102 cm (men)/88 cm (women).
- BMI <40.
Who cannot join
- Medically treated allergy or allergy to any of the ingredients of the study product.
- Medication for high levels of blood lipids.
- Metabolic disease, such as type one diabetes.
- Confirmed diseases of the heart, liver of kidneys.
- Chronic inflammatory disease requiring medication.
- Pregnant or nursing.
- Regular intake of other probiotic products (5-7 days per week during the last three months before inclusion into the study).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Probiotic-based Product on Blood Pressure and Other Known Risk Factors Linked to Cardiovascular Diseases.
The aim of the present study was to examine the efficacy of a probiotic-based product on either reducing hypertension or preventing a high normal blood pressure from reaching hypertensive levels.
- Conditions
- Blood Pressure
- Being tested
- Fermented blueberry drink, Placebo drink, Sachets with probiotic bacterial powder, Sachets with placebo powder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fermented blueberry drinkOther
Placebo drinkOther
Sachets with probiotic bacterial powderOther
Sachets with placebo powderOther
| Study group | Role | What they receive |
|---|---|---|
| Fermented blueberry product | Active comparator | Not described Receives: Other: Fermented blueberry drink; Other: Sachets with placebo powder |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo drink; Other: Sachets with placebo powder |
| Probiotic bacteria | Active comparator | Not described Receives: Other: Placebo drink; Other: Sachets with probiotic bacterial powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in systolic and diastolic blood pressure after 3 months of probiotic intervention
Measured: Baseline, 3 months
Secondary outcomes (1)
Changes from baseline of blood parameters, such as inflammatory markers and blood lipids, linked to increased risk for cardiovascular diseases
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startOct 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Probi AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01989702
- Sponsor's protocol ID
- ProMeta
- Status last verified
- Nov 2013
- First submitted
- 7 Nov 2013
- Last updated
- 21 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Probiotic-based Product on Blood Pressure and Other Known Risk Factors Linked to Cardiovascular Diseases.
- ClinicalTrials.gov ID
- NCT01989702
- Acronym / sponsor ID
- ProMeta
- Conditions
- Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Probi ABIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 21 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present study was to examine the efficacy of a probiotic-based product on either reducing hypertension or preventing a high normal blood pressure from reaching hypertensive levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fermented blueberry product | Active comparator | Other: Fermented blueberry drink, Other: Sachets with placebo powder |
| Placebo | Placebo comparator | Other: Placebo drink, Other: Sachets with placebo powder |
| Probiotic bacteria | Active comparator | Other: Placebo drink, Other: Sachets with probiotic bacterial powder |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy individuals at the age of 40-75 years.
- Blood-pressure >140/90 mmHg that has been confirmed at 2-3 separate occasions or represents the mean value of a 24-hour measurement.
- Triglycerides >1,7 mmol/L and/or HDL <1 mmol/L (men)/1,29 mmol/L (women).
- Fasting plasma glucose levels >5,6 mmol/L and/or waist circumference >102 cm (men)/88 cm (women).
- BMI <40.
Key exclusion criteria (7 listed)
- Medically treated allergy or allergy to any of the ingredients of the study product.
- Medication for high levels of blood lipids.
- Metabolic disease, such as type one diabetes.
- Confirmed diseases of the heart, liver of kidneys.
- Chronic inflammatory disease requiring medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fermented blueberry drink | Other | Fermented blueberry product |
| Placebo drink | Other | Placebo, Probiotic bacteria |
| Sachets with probiotic bacterial powder | Other | Probiotic bacteria |
| Sachets with placebo powder | Other | Fermented blueberry product, Placebo |
Primary outcome
Changes from baseline in systolic and diastolic blood pressure after 3 months of probiotic intervention
Time frame: Baseline, 3 months
1 secondary outcome
Changes from baseline of blood parameters, such as inflammatory markers and blood lipids, linked to increased risk for cardiovascular diseases
Time frame: Baseline, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2013.
Related trials for Blood Pressure
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
RecruitingPhase 3
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
Chronic Kidney Disease and Hypertension
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingPhase 4
Hematological Safety of Dipyrone Versus Paracetamol After Dental Extractions
Hematologic Test, Agranulocytosis
Not yet recruiting
Acute Effects of Mat Pilates on Blood Pressure Response to Mental Stress in Higher Education Teachers
Behavior
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fermented blueberry drink and Sachets with probiotic bacterial powder in people with Blood Pressure, run by Probi AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in systolic and diastolic blood pressure after 3 months of probiotic intervention (time frame: Baseline, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2013.