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Synbiotics and Low Grade Inflammation in Obese Subjects

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ClinicalTrials.gov Identifier: NCT01235026
Recruitment Status : Unknown
Verified October 2010 by University of Chile.
Recruitment status was:  Recruiting
First Posted : November 5, 2010
Last Update Posted : December 17, 2010
Sponsor:
Information provided by:
University of Chile

Tracking Information
First Submitted Date  ICMJE November 1, 2010
First Posted Date  ICMJE November 5, 2010
Last Update Posted Date December 17, 2010
Study Start Date  ICMJE November 2010
Estimated Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2010)
Plasmatic Interleukin-6 (IL-6) [ Time Frame: 6 weeks ]
Plasmatic IL-6 will be determined after 6 weeks of administration of the synbiotic and compared with the IL-6 values at baseline.
Original Primary Outcome Measures  ICMJE
 (submitted: November 4, 2010)
Plasmatic Interleukin-6 (IL-6) [ Time Frame: 0, 6 weeks, 10 weeks ]
Plasmatic IL-6 will be measured before treatment, after 6 weeks of administration of the synbiotic and after a 1-month washout period without synbiotic administration (week 10).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2010)
  • Plasmatic LPS-binding protein [ Time Frame: 6 weeks ]
    Plasmatic LPS-binding protein (LBP) will be determined after 6 weeks of administration of the synbiotic and compared with the LBP values at baseline.
  • Plasmatic sCD14 [ Time Frame: 6 weeks ]
    Plasmatic sCD14 will be determined after 6 weeks of administration of the synbiotic and compared with the sCD14 values at baseline.
  • glucose tolerance curve [ Time Frame: 6 weeks ]
    Glucose tolerance will be determined after 6 weeks of administration of the synbiotic and compared with glucose tolerance at baseline.
  • Lipid profile [ Time Frame: 6 weeks ]
    Lipid profile will be determined after 6 weeks of administration of the synbiotic and compared with the lipid profile at baseline.
  • plasmatic ultrasensitive C-Reactive Protein [ Time Frame: 6 weeks ]
    Plasmatic ultrasensitive CRP will be determined after 6 weeks of administration of the synbiotic and compared with the usCRP values at baseline.
  • Plasmatic IL-6 [ Time Frame: 10 weeks ]
    Plasmatic IL-6 will be determined after a 1-month washout period without synbiotic administration (week 10)and compared with the baseline and post-treatment (6 weeks) values.
  • Plasmatic LBP [ Time Frame: 10 weeks ]
    Plasmatic LBP will be determined after a 1-month washout period without synbiotic administration (week 10)and compared with the baseline and post-treatment (6 weeks) values.
  • Plasmatic sCD14 [ Time Frame: 10 weeks ]
    Plasmatic sCD14 will be determined after a 1-month washout period without synbiotic administration (week 10)and compared with the baseline and post-treatment (6 weeks) values.
  • Glucose tolerance curve [ Time Frame: 10 weeks ]
    Glucose tolerance curves will be determined after a 1-month washout period without synbiotic administration (week 10)and compared with the baseline and post-treatment (6 weeks) values.
  • Lipid profile [ Time Frame: 10 weeks ]
    Lipid profile will be determined after a 1-month washout period without synbiotic administration (week 10)and compared with the baseline and post-treatment (6 weeks) values.
  • Plasmatic usCRP [ Time Frame: 10 weeks ]
    Plasmatic usCRP will be determined after a 1-month washout period without synbiotic administration (week 10)and compared with the baseline and post-treatment (6 weeks) values.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2010)
  • Plasmatic LPS-binding protein [ Time Frame: 0, 6 weeks, 10 weeks ]
  • Plasmatic sCD14 [ Time Frame: 0, 6 weeks, 10 weeks ]
  • glucose tolerance curve [ Time Frame: 0, 6 weeks, 10 weeks ]
  • Lipid profile [ Time Frame: 0, 6 weeks, 10 weeks ]
  • plasmatic ultrasensitive C-Reactive Protein [ Time Frame: 0, 6 weeks, 10 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Synbiotics and Low Grade Inflammation in Obese Subjects
Official Title  ICMJE Impact of the Administration of a Synbiotic on Low Grade Inflammation in Obese Subjects
Brief Summary The purpose of this study is to determine whether the daily administration of a synbiotic (oligofructose and Bifidobacterium animalis subsp. lactis Bb12) for six weeks contributes to improve the glucose tolerance and the low grade inflammation (as reflected as the plasmatic concentrations of ultrasensitive CRP, IL-6, sCD14 and LPS-binding protein) in obese subjects.
Detailed Description

Obesity is associated with a spectrum of metabolic disorders including high blood pressure, dyslipidemia, insulin resistance and a state of low grade inflammation that predispose individuals to the development of type-2 diabetes mellitus and cardiovascular diseases. The intestinal microbiota has been recently proposed as a new actor in the development of obesity and its complications. In animal models, high-fat diets have been shown to affect the intestinal microbiota, increasing colonic gram-negative bacteria and lipopolysaccharide (LPS) concentrations, resulting in an impaired gastrointestinal barrier function and in subsequent endotoxinemia in the animals. This phenomenon would trigger chronic inflammatory and metabolic disorders leading to insulin resistance and other complication such as hepatic steatosis. Probiotics and prebiotics are GRAS (Generally recognized as safe) food ingredients which have been proposed to maintain the balance of the intestinal microbiota. Studies in mice fed a high fat diet have shown that the administration of oligofructose increases the counts of Bifidobacterium spp. in the colon and correlatively induced decreases of the endotoxinemia and low-grade inflammation while at the same time improving insulin sensitivity.

On the basis of these antecedents, the aim of this study is to determine whether the intake of a synbiotic product (B. animalis subsp. lactis BB12+ Oligofructose) for six weeks contributes to improve the low grade inflammation and glucose tolerance of obese subjects.

Obese subjects will be randomized into two groups (Synbiotic or Placebo) stratifying by sex and age. Anthropometric data (body composition by Bod-pod, weight, height, waist circumference) and systolic and diastolic blood pressure will be registered. A food survey will be carried out by a trained dietitian to quantify fat consumption. Each subject of the Synbiotic group must ingest one gram of BB12 (containing 1010 CFU) and 5 g of oligofructose twice a day for 6 weeks while those from the Control group will receive the corresponding placebo (maltodextrin). Digestive symptoms as well as stool frequency and consistency will be registered daily during the study using ad hoc forms and the Bristol Chart.

Blood samples will be obtained at baseline, at the end of the six weeks period and one month after the end of the treatment, to determine lipid profiles and ultrasensitive C-reactive protein (CRP); plasmatic biomarkers of inflammation including IL-6, LPS binding protein and sCD14 will be also determined by Elisa using commercial kits. At the same times, a glycemia /insulinemia curve will be performed in the fasted subjects, as well as an intestinal permeability test (lactulose/mannitol/sucralose) to assess their gut barrier function. A fresh stool sample will be also obtained to characterize some bacterial population of their IM (Bifidobacterium, Lactobacillus, F. prausnitzii, Bacteroides and Clostridium cluster) by real-time PCR.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE
  • Obesity
  • Diabetes Mellitus Type-2
  • Insulin Resistance
  • Metabolic Syndrome
Intervention  ICMJE
  • Dietary Supplement: Synbiotic
    5g of the prebiotic "Oligofructose" + 1 g of the probiotic "Bifidobacterium animalis subsp. lactis Bb12" (4x10^10 CFU/g), twice a day, for 6 weeks.
  • Dietary Supplement: Placebo
    6g of maltodextrin, twice a day for 6 weeks.
Study Arms  ICMJE
  • Experimental: Synbiotic
    Dietary Supplement: Synbiotic: combination of the prebiotic "Oligofructose" with the probiotic "Bifidobacterium animalis subsp. lactis Bb12"
    Intervention: Dietary Supplement: Synbiotic
  • Placebo Comparator: Placebo
    Dietary supplement: placebo: maltodextrin
    Intervention: Dietary Supplement: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 4, 2010)
44
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2011
Estimated Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • BMI > 30
  • Non-smokers

Exclusion Criteria:

  • Current digestive diseases or antecedents of chronic digestive diseases and/or malabsorption (celiac disease, Inflammatory bowel diseases, gastroduodenal ulcers, digestive malignancies, etc)
  • Use of drugs that could interfere with the intestinal microbiota or with the integrity of the gut barrier function (antibiotics, anti-inflammatory drugs, laxatives, prokinetics, etc.) during the three weeks preceding the start the study
  • Treatments (medication or nutritional program) affecting body weight or glucose control
  • Basal glycemia>130mg/dl (evaluated with glucose-meter)
  • Immunodeficiencies (HIV, chemotherapy, radiotherapy, organ transplant).
  • Current participation or recent previous having participation in another clinical trial.
  • Pregnant or breastfeeding women.
  • Consumption of probiotic products
  • Drug or alcohol abuse
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Chile
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01235026
Other Study ID Numbers  ICMJE Fondecyt-1080519
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Martin Gotteland, University of Chile
Study Sponsor  ICMJE University of Chile
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Chile
Verification Date October 2010

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