Effect of a Probiotic-based Product on Blood Pressure

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01989702
• Other study ID #: ProMeta
• Status: Completed
• Phase: N/A
• First received: November 7, 2013
• Last updated: November 14, 2013
• Start date: October 2010
• Est. completion date: June 2011

Study information

• Verified date: November 2013
• Source: Probi AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Ethical review Board
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Other:
• Fermented blueberry drink

• Placebo drink

• Sachets with probiotic bacterial powder

• Sachets with placebo powder

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Probi AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Effect of study product on intestinal microbiota as analysed in fecal samples		Baseline, 3 months	No
Primary	Changes from baseline in systolic and diastolic blood pressure after 3 months of probiotic intervention		Baseline, 3 months	No
Secondary	Changes from baseline of blood parameters, such as inflammatory markers and blood lipids, linked to increased risk for cardiovascular diseases		Baseline, 3 months	No