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.

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 Overview

• Status: Completed
• Conditions: Blood Pressure
• Intervention / Treatment: Other: Placebo drink; Other: Fermented blueberry drink; Other: Sachets with placebo powder; Other: Sachets with probiotic bacterial powder

• Study Type: Interventional
• Enrollment (Actual): 142
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Malmö, Sweden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo drink; Other: Sachets with placebo powder
Active Comparator: Fermented blueberry product	Other: Fermented blueberry drink; Other: Sachets with placebo powder
Active Comparator: Probiotic bacteria	Other: Placebo drink; Other: Sachets with probiotic bacterial powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes from baseline in systolic and diastolic blood pressure after 3 months of probiotic intervention	Baseline, 3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes from baseline of blood parameters, such as inflammatory markers and blood lipids, linked to increased risk for cardiovascular diseases	Baseline, 3 months

Other Outcome Measures

Outcome Measure	Time Frame
Effect of study product on intestinal microbiota as analysed in fecal samples	Baseline, 3 months

Collaborators and Investigators

• Sponsor: Probi AB

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: November 7, 2013
• First Submitted That Met QC Criteria: November 14, 2013
• First Posted (Estimate): November 21, 2013

Study Record Updates

• Last Update Posted (Estimate): November 21, 2013
• Last Update Submitted That Met QC Criteria: November 14, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: ProMeta