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Probiotics and Endotoxemia (PROMS-01)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Danisco.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Danisco
ClinicalTrials.gov Identifier:
NCT01176942
First received: May 24, 2010
Last updated: August 5, 2010
Last verified: August 2010
History of Changes
  Purpose

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 Intervention
Metabolic Endotoxemia
Metabolic Syndrome
 Dietary Supplement: Probiotic bacterium Bifidobacterium lactis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Probiotics and Endotoxemia in Humans

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Danisco:

Primary Outcome Measures:
  • Level of plasma endotoxin (plasma levels of lipopolysaccharides) in the volunteers before and after the 12 week intervention [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Volunteer waist perimeter before and after the 12 week intervention [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Insulin resistance (HOMA-IR index), glycemia, insulinemia and glycated hemoglobin in the volunteers before and after the 12 week intervention [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Blood lipids in the volunteers before and after the 12 week intervention. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 90
Study Start Date: May 2010
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Probiotic Dietary Supplement: Probiotic bacterium Bifidobacterium lactis
Probiotic placebo controlled intervention
Other Name: Bifidobacterium animalis subsp. lactis
Placebo Comparator: Placebo Dietary Supplement: Probiotic bacterium Bifidobacterium lactis
Probiotic placebo controlled intervention
Other Name: Bifidobacterium animalis subsp. lactis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01176942

Locations
France
CHU Toulouse Hospital
Toulouse, Cedex 9, France
Sponsors and Collaborators
Danisco
  More Information

No publications provided

Responsible Party: Principal Investigator Professor Jacques Amar, Service de Médecine et d'Hypertension Artérielle, CHU Purpan
ClinicalTrials.gov Identifier: NCT01176942     History of Changes
Other Study ID Numbers: PROMS-01
Study First Received: May 24, 2010
Last Updated: August 5, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Endotoxemia
Metabolic Syndrome X
Bacteremia
Sepsis
Infection
Toxemia
Systemic Inflammatory Response Syndrome
 Inflammation
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 21, 2013