Probiotics and Endotoxemia

Not Applicable

Completed

• Conditions: Metabolic Endotoxemia; Metabolic Syndrome
• Interventions: Dietary Supplement: Probiotic bacterium Bifidobacterium lactis

• Registration Number: NCT01176942
• Lead Sponsor: Danisco

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 available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-24
• Study First Submitted QC: 2010-08-05
• Study First Posted: 2010-08-06
• Primary Completion: 2010-12
• Study Completion: 2011-05
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-08
• Last Update Posted: 2014-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic	Probiotic bacterium Bifidobacterium lactis	-
Placebo	Probiotic bacterium Bifidobacterium lactis	-

Primary Outcome Measures

Name	Time	Method
Level of plasma endotoxin (plasma levels of lipopolysaccharides) in the volunteers before and after the 12 week intervention	12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Brachial blood pressure of the volunteers before and after the 12 week intervention.	12 weeks
Insulin resistance (HOMA-IR index), glycemia, insulinemia and glycated hemoglobin in the volunteers before and after the 12 week intervention	12 weeks	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.
Volunteer weight before and after the 12 week intervention.	12 weeks
Volunteer waist perimeter before and after the 12 week intervention	12 weeks
Serum inflammatory markers of volunteers before and after the 12 week intervention.	12 weeks	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.
Blood lipids in the volunteers before and after the 12 week intervention.	12 weeks	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.
Intestinal microbiota composition measured from stool samples before and after the 12 week intervention.	12 weeks	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	Symptoms during last 6 days	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.

Trial Locations

Locations (1)

CHU Toulouse Hospital; 🇫🇷 Toulouse, Cedex 9, France