Effect of a Probiotic-based Product on Blood Pressure

Not Applicable

Completed

• Conditions: Blood Pressure
• Interventions: Other: Fermented blueberry drink; Other: Placebo drink; Other: Sachets with placebo powder; Other: Sachets with probiotic bacterial powder

• Registration Number: NCT01989702
• Lead Sponsor: Probi AB

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2013-11
• Study First Submitted: 2013-11-07
• Study First Submitted QC: 2013-11-14
• Last Update Submitted: 2013-11-14
• Study First Posted: 2013-11-21
• Last Update Posted: 2013-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fermented blueberry product	Fermented blueberry drink	-
Fermented blueberry product	Sachets with placebo powder	-
Placebo	Placebo drink	-
Placebo	Sachets with placebo powder	-
Probiotic bacteria	Placebo drink	-
Probiotic bacteria	Sachets with probiotic bacterial powder	-

Primary Outcome Measures

Name	Time	Method
Changes from baseline in systolic and diastolic blood pressure after 3 months of probiotic intervention	Baseline, 3 months

Secondary Outcome Measures

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