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Completed

NCT Number: NCT01989702

Effect of a Probiotic-based Product on Blood Pressure

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.

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Key information

Conditions

Blood Pressure

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Malmö, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Fermented blueberry drink

Other

Placebo drink

Other

Sachets with probiotic bacterial powder

Other

Sachets with placebo powder

Other

Primary outcomes

  1. Changes from baseline in systolic and diastolic blood pressure after 3 months of probiotic intervention

    Time frame: Baseline, 3 months

Secondary outcomes

  1. Changes from baseline of blood parameters, such as inflammatory markers and blood lipids, linked to increased risk for cardiovascular diseases

    Time frame: Baseline, 3 months

Other outcomes

  1. Effect of study product on intestinal microbiota as analysed in fecal samples

    Time frame: Baseline, 3 months

Sponsors and collaborators

Lead sponsor

Probi AB

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 21, 2013
Registry last updated
Nov 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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