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Probiotics and Endotoxemia

NCT ID: NCT01176942

Last Updated: 2014-12-09

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-05-31

Brief Summary

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The purpose of this study is to determine whether probiotic treatment of overweight volunteers consuming high fat diet is able to reduce plasma lipopolysaccharide concentration.

Detailed Description

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Conditions

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Metabolic Endotoxemia Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Probiotic

Group Type EXPERIMENTAL

Probiotic bacterium Bifidobacterium lactis

Intervention Type DIETARY_SUPPLEMENT

Probiotic placebo controlled intervention

Placebo

Group Type PLACEBO_COMPARATOR

Probiotic bacterium Bifidobacterium lactis

Intervention Type DIETARY_SUPPLEMENT

Probiotic placebo controlled intervention

Interventions

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Probiotic bacterium Bifidobacterium lactis

Probiotic placebo controlled intervention

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Bifidobacterium animalis subsp. lactis

Eligibility Criteria

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Inclusion Criteria

* Body mass index ≥ 27 kg/m2; above 18 years of age
* Used to eat high fat diet (more than 40% of total energy intake)

Exclusion Criteria

* Treated cardiovascular risk factors, treated hypertension, treated dyslipidemia, treated diabetes; Known diabetes, hypertension, dyslipidemia
* Severe illnesses
* Artificial heart valve
* Immunosuppression
* Regular consumption of probiotics
* History of bariatric surgery
* Consumption or wish to consume Orlistat
* Participation in other research
* Pregnancy or wishing/trying to get pregnant
* Inability to follow protocol.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Danisco

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Toulouse Hospital

Toulouse, Cedex 9, France

Site Status

Countries

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France

Other Identifiers

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PROMS-01

Identifier Type: -

Identifier Source: org_study_id