Probiotics and Endotoxemia (PROMS-01)

Probiotics and Endotoxemia in Humans

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome; Metabolic Endotoxemia
• Intervention / Treatment: Dietary supplement: Probiotic bacterium Bifidobacterium lactis

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Cedex 9
    • Toulouse, Cedex 9, France
      • CHU Toulouse Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Probiotic bacterium Bifidobacterium lactis; Probiotic placebo controlled intervention; Other Names: Bifidobacterium animalis subsp. lactis
Experimental: Probiotic	Dietary supplement: Probiotic bacterium Bifidobacterium lactis; Probiotic placebo controlled intervention; Other Names: Bifidobacterium animalis subsp. lactis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of plasma endotoxin (plasma levels of lipopolysaccharides) in the volunteers before and after the 12 week intervention	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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volunteer weight before and after the 12 week intervention.		12 weeks
Volunteer waist perimeter 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	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.	12 weeks
Brachial blood pressure of the volunteers before and after the 12 week intervention.		12 weeks
Blood lipids in the volunteers before and after the 12 week intervention.	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.	12 weeks
Serum inflammatory markers of volunteers before and after the 12 week intervention.	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.	12 weeks
Intestinal microbiota composition measured from stool samples before and after the 12 week intervention.	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.	12 weeks
Gut function questionaire as a measure of tolerability	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.	Symptoms during last 6 days

Collaborators and Investigators

• Sponsor: Danisco

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: May 24, 2010
• First Submitted That Met QC Criteria: August 5, 2010
• First Posted (Estimate): August 6, 2010

Study Record Updates

• Last Update Posted (Estimate): December 9, 2014
• Last Update Submitted That Met QC Criteria: December 8, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Insulin Resistance; Hyperinsulinism; Bacteremia; Toxemia; Metabolic Syndrome; Endotoxemia
• Other Study ID Numbers: PROMS-01