Probiotics and Endotoxemia

Metabolic Syndrome Clinical Trial

— PROMS-01  

Official title:

Probiotics and Endotoxemia in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01176942
• Other study ID #: PROMS-01
• Status: Completed
• Phase: N/A
• First received: May 24, 2010
• Last updated: December 8, 2014
• Start date: May 2010
• Est. completion date: May 2011

Study information

• Verified date: December 2014
• Source: Danisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endotoxemia
• Metabolic Endotoxemia
• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Dietary Supplement:
• Probiotic bacterium Bifidobacterium lactis
Probiotic placebo controlled intervention

Locations

Country	Name	City	State
France	CHU Toulouse Hospital	Toulouse	Cedex 9

Sponsors (1)

Lead Sponsor	Collaborator
Danisco

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Volunteer weight before and after the 12 week intervention.		12 weeks	No
Secondary	Volunteer waist perimeter before and after the 12 week intervention		12 weeks	No
Secondary	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	No
Secondary	Brachial blood pressure of the volunteers before and after the 12 week intervention.		12 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes