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Effect of a Probiotic-based Product on Blood Pressure

The Effect of a Probiotic-based Product on Blood Pressure and Other Known Risk Factors Linked to Cardiovascular Diseases.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01989702
Enrollment
142
Registered
2013-11-21
Start date
2010-10-31
Completion date
2011-06-30
Last updated
2013-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure

Brief 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.

Interventions

OTHERFermented blueberry drink
OTHERPlacebo drink
OTHERSachets with probiotic bacterial powder
OTHERSachets with placebo powder

Sponsors

Probi AB
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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).

Design outcomes

Primary

MeasureTime frame
Changes from baseline in systolic and diastolic blood pressure after 3 months of probiotic interventionBaseline, 3 months

Secondary

MeasureTime frame
Changes from baseline of blood parameters, such as inflammatory markers and blood lipids, linked to increased risk for cardiovascular diseasesBaseline, 3 months

Other

MeasureTime frame
Effect of study product on intestinal microbiota as analysed in fecal samplesBaseline, 3 months

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026