Probiotics and Endotoxemia (PROMS-01)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified August 2010 by Danisco.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Danisco

ClinicalTrials.gov Identifier:

NCT01176942

First received: May 24, 2010

Last updated: August 5, 2010

Last verified: August 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	May 24, 2010
Last Updated Date	August 5, 2010
Start Date ^ICMJE	May 2010
Estimated Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 5, 2010)	Level of plasma endotoxin (plasma levels of lipopolysaccharides) in the volunteers before and after the 12 week intervention [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] Quantitative, kinetic assay for the detection of gram negative bacterial endotoxin (lipopolysaccharide) is used to test whether the probiotic intervention can reduce plasma endotoxin levels (IU/ml) compared to the baseline.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01176942 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 5, 2010)	Volunteer weight before and after the 12 week intervention. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] Volunteer waist perimeter before and after the 12 week intervention [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] Insulin resistance (HOMA-IR index), glycemia, insulinemia and glycated hemoglobin in the volunteers before and after the 12 week intervention [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] Insulin resistance (IR) will be quantified in the non-diabetic adults using the HOMA-IR index calculated as the product of fasting plasma insulin (in microunits per milliliter) and fasting plasma glucose (in millimoles per liter), divided by 22.5. Higher HOMA values indicate higher IR. Glycated haemoglobin is used as a biological measure indicator of blood glucose concentration over 3 months. Brachial blood pressure of the volunteers before and after the 12 week intervention. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] Blood lipids in the volunteers before and after the 12 week intervention. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] Plasma total cholesterol and triglycerides are measured by enzymatic methods. High-density lipoprotein (HDL) cholesterol is measured in the supernatant after sodium phosphotungstate/magnesium chloride precipitation. Low-density lipoprotein (LDL) cholesterol is determined by the Friedewald formula. Serum inflammatory markers of volunteers before and after the 12 week intervention. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] IL-6 (Interleukin-6) level is measured by an immunoenzymatic method, sCD14 is measured using an immuno-enzymatic method, and C reactive protein (CRP) levels is measured by an immunonephelemetric method. Intestinal microbiota composition measured from stool samples before and after the 12 week intervention. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] Stool samples are collected before and after the intervention and stored frozen until analysis. Bacterial DNA is extracted from the samples and relevant bacterial groups including genus Bifidobacterium, species Bifidobacterium animalis subsp. lactis, Enterobacteriaceae, Escherichia coli, Bacteroidetes and Lactobacillus are measures with quantitative real-time PCR. Gut function questionaire as a measure of tolerability [ Time Frame: Symptoms during last 6 days ] [ Designated as safety issue: Yes ] Questionaire is used to assess the tolerability of the probiotic supplementation. Questionaire includes questions on frequency and severity of flatulence and bloating, occurence of diarhea, frequency of defecation, and texture of feces using a stool chart.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Probiotics and Endotoxemia
Official Title ^ICMJE	Probiotics and Endotoxemia in Humans
Brief Summary	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	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Metabolic Endotoxemia Metabolic Syndrome
Intervention ^ICMJE	Dietary Supplement: Probiotic bacterium Bifidobacterium lactis Probiotic placebo controlled intervention Other Name: Bifidobacterium animalis subsp. lactis
Study Arm (s)	Experimental: Probiotic Intervention: Dietary Supplement: Probiotic bacterium Bifidobacterium lactis Placebo Comparator: Placebo Intervention: Dietary Supplement: Probiotic bacterium Bifidobacterium lactis
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	90
Estimated Completion Date	May 2011
Estimated Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	France

Administrative Information
NCT Number ^ICMJE	NCT01176942
Other Study ID Numbers ^ICMJE	PROMS-01
Has Data Monitoring Committee	Not Provided
Responsible Party	Principal Investigator Professor Jacques Amar, Service de Médecine et d'Hypertension Artérielle, CHU Purpan
Study Sponsor ^ICMJE	Danisco
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Danisco
Verification Date	August 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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