Effect of a Probiotic-based Product on Blood Pressure

Probi AB

Status: Completed

Conditions: Blood Pressure

Treatments: Other: Sachets with probiotic bacterial powder; Other: Sachets with placebo powder; Other: Placebo drink; Other: Fermented blueberry drink

Study type: Interventional

Funder types: Industry

Identifiers

NCT01989702

ProMeta

Details and patient eligibility

About

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.

Enrollment: 142 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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142 participants in 3 patient groups, including a placebo group

Fermented blueberry product

Active Comparator group

Treatment:

Other: Sachets with placebo powder

Other: Fermented blueberry drink

Placebo

Placebo Comparator group

Treatment:

Other: Sachets with placebo powder

Other: Placebo drink

Probiotic bacteria

Active Comparator group

Treatment:

Other: Placebo drink

Other: Sachets with probiotic bacterial powder