NCT01989702

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

November 7, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 21, 2013

Completed
Last Updated

November 21, 2013

Status Verified

November 1, 2013

Enrollment Period

8 months

First QC Date

November 7, 2013

Last Update Submit

November 14, 2013

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (1)

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

    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

    Baseline, 3 months

Other Outcomes (1)

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

    Baseline, 3 months

Study Arms (3)

Fermented blueberry product

ACTIVE COMPARATOR
Other: Fermented blueberry drinkOther: Sachets with placebo powder

Placebo

PLACEBO COMPARATOR
Other: Placebo drinkOther: Sachets with placebo powder

Probiotic bacteria

ACTIVE COMPARATOR
Other: Placebo drinkOther: Sachets with probiotic bacterial powder

Interventions

Fermented blueberry drinkOTHER
Fermented blueberry product
Placebo drinkOTHER
PlaceboProbiotic bacteria
Sachets with probiotic bacterial powderOTHER
Probiotic bacteria
Sachets with placebo powderOTHER
Fermented blueberry productPlacebo

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Malmo, Sweden

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2013

First Posted

November 21, 2013

Study Start

October 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

November 21, 2013

Record last verified: 2013-11

Locations

SE(1)