Clinical Trial: Probiotics and Endotoxemia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Probiotics and Endotoxemia in Humans

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 Summary:
Sponsor: Danisco

Current Primary Outcome: Level of plasma endotoxin (plasma levels of lipopolysaccharides) in the volunteers before and after the 12 week intervention [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Volunteer weight before and after the 12 week intervention. [ Time Frame: 12 weeks ]
  • Volunteer waist perimeter before and after the 12 week intervention [ Time Frame: 12 weeks ]
  • Insulin resistance (HOMA-IR index), glycemia, insulinemia and glycated hemoglobin in the volunteers before and after the 12 week intervention [ Time Frame: 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.
  • Brachial blood pressure of the volunteers before and after the 12 week intervention. [ Time Frame: 12 weeks ]
  • Blood lipids in the volunteers before and after the 12 week intervention. [ Time Frame: 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.
  • Serum inflammatory markers of volunteers before and after the 12 week intervention. [ Time Frame: 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.
  • Intestinal microbiota composition measured from stool samples before and after the 12 week intervention. [ Time Frame: 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 [ Time Frame: 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.


Original Secondary Outcome: Same as current

Information By: Danisco

Dates:
Date Received: May 24, 2010
Date Started: May 2010
Date Completion:
Last Updated: December 8, 2014
Last Verified: December 2014