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PROMS-01: Probiotics and Endotoxemia

Sponsor
Danisco (Industry)
Overall Status
Completed
CT.gov ID
NCT01176942
Collaborator
(none)
90
Enrollment
1
Location
2
Arms
12
Duration (Months)
7.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Probiotic bacterium Bifidobacterium lactis
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Probiotics and Endotoxemia in Humans
Study Start Date :
May 1, 2010
Actual Primary Completion Date :
Dec 1, 2010
Actual Study Completion Date :
May 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Probiotic

Dietary Supplement: Probiotic bacterium Bifidobacterium lactis
Probiotic placebo controlled intervention
Other Names:
  • Bifidobacterium animalis subsp. lactis

    		•
    Placebo Comparator: Placebo

    Dietary Supplement: Probiotic bacterium Bifidobacterium lactis
    Probiotic placebo controlled intervention
    Other Names:
  • Bifidobacterium animalis subsp. lactis

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Volunteer weight before and after the 12 week intervention. [12 weeks]

    2. Volunteer waist perimeter before and after the 12 week intervention [12 weeks]

    3. 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.

    4. Brachial blood pressure of the volunteers before and after the 12 week intervention. [12 weeks]

    5. 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.

    6. 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.

    7. 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.

    8. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU Toulouse Hospital Toulouse Cedex 9 France

    Sponsors and Collaborators

    • Danisco

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Danisco
    ClinicalTrials.gov Identifier:
    NCT01176942
    Other Study ID Numbers:
    • PROMS-01
    First Posted:
    Aug 6, 2010
    Last Update Posted:
    Dec 9, 2014
    Last Verified:
    Dec 1, 2014
    Additional relevant MeSH terms:
    Endotoxemia
    Metabolic Syndrome

    Study Results

    No Results Posted as of Dec 9, 2014