Effect of a Probiotic-based Product on Blood Pressure

NCT ID: NCT01989702

Last Updated: 2013-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Blood Pressure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fermented blueberry product

Group Type ACTIVE_COMPARATOR

Fermented blueberry drink

Intervention Type OTHER

Sachets with placebo powder

Intervention Type OTHER

Placebo

Group Type PLACEBO_COMPARATOR

Placebo drink

Intervention Type OTHER

Sachets with placebo powder

Intervention Type OTHER

Probiotic bacteria

Group Type ACTIVE_COMPARATOR

Placebo drink

Intervention Type OTHER

Sachets with probiotic bacterial powder

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fermented blueberry drink

Intervention Type OTHER

Placebo drink

Intervention Type OTHER

Sachets with probiotic bacterial powder

Intervention Type OTHER

Sachets with placebo powder

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Probi AB

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Malmo, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ProMeta

Identifier Type: -

Identifier Source: org_study_id