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Completed

NCT Number: NCT01176942

Probiotics and Endotoxemia

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.

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Key information

Conditions

Metabolic Endotoxemia Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Toulouse Hospital

Toulouse, Cedex 9, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Probiotic bacterium Bifidobacterium lactis

Dietary Supplement

Probiotic placebo controlled intervention

Other names: Bifidobacterium animalis subsp. lactis

Primary outcomes

  1. 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.

Secondary outcomes

  1. Volunteer weight before and after the 12 week intervention.

    Time frame: 12 weeks

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

    Time frame: 12 weeks

  3. 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.

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

    Time frame: 12 weeks

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Danisco

Industry

Registry information

Official study title

Probiotics and Endotoxemia in Humans

Acronym: PROMS-01

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Aug 6, 2010
Registry last updated
Dec 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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