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

May 24, 2010
August 5, 2010
May 2010
December 2010   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01176942 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Probiotics and Endotoxemia
Probiotics and Endotoxemia in Humans

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Metabolic Endotoxemia
  • Metabolic Syndrome
Dietary Supplement: Probiotic bacterium Bifidobacterium lactis
Probiotic placebo controlled intervention
Other Name: Bifidobacterium animalis subsp. lactis
  • Experimental: Probiotic
    Intervention: Dietary Supplement: Probiotic bacterium Bifidobacterium lactis
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Probiotic bacterium Bifidobacterium lactis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
90
May 2011
December 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01176942
PROMS-01
Not Provided
Principal Investigator Professor Jacques Amar, Service de Médecine et d'Hypertension Artérielle, CHU Purpan
Danisco
Not Provided
Not Provided
Danisco
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP