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Probiotics and Endotoxemia (PROMS-01)

Primary Purpose

Metabolic Endotoxemia, Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Probiotic bacterium Bifidobacterium lactis
Sponsored by
Danisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Endotoxemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • CHU Toulouse Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotic

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Volunteer weight before and after the 12 week intervention.
Volunteer waist perimeter before and after the 12 week intervention
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.
Brachial blood pressure of the volunteers before and after the 12 week intervention.
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.
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.
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.
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.

Full Information

First Posted
May 24, 2010
Last Updated
December 8, 2014
Sponsor
Danisco
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1. Study Identification

Unique Protocol Identification Number
NCT01176942
Brief Title
Probiotics and Endotoxemia
Acronym
PROMS-01
Official Title
Probiotics and Endotoxemia in Humans
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Danisco

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Endotoxemia, Metabolic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probiotic
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic bacterium Bifidobacterium lactis
Other Intervention Name(s)
Bifidobacterium animalis subsp. lactis
Intervention Description
Probiotic placebo controlled intervention
Primary Outcome Measure Information:
Title
Level of plasma endotoxin (plasma levels of lipopolysaccharides) in the volunteers before and after the 12 week intervention
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Volunteer weight before and after the 12 week intervention.
Time Frame
12 weeks
Title
Volunteer waist perimeter before and after the 12 week intervention
Time Frame
12 weeks
Title
Insulin resistance (HOMA-IR index), glycemia, insulinemia and glycated hemoglobin in the volunteers before and after the 12 week intervention
Description
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.
Time Frame
12 weeks
Title
Brachial blood pressure of the volunteers before and after the 12 week intervention.
Time Frame
12 weeks
Title
Blood lipids in the volunteers before and after the 12 week intervention.
Description
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.
Time Frame
12 weeks
Title
Serum inflammatory markers of volunteers before and after the 12 week intervention.
Description
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.
Time Frame
12 weeks
Title
Intestinal microbiota composition measured from stool samples before and after the 12 week intervention.
Description
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.
Time Frame
12 weeks
Title
Gut function questionaire as a measure of tolerability
Description
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.
Time Frame
Symptoms during last 6 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
CHU Toulouse Hospital
City
Toulouse
State/Province
Cedex 9
Country
France

12. IPD Sharing Statement

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