Synbiotics and Low Grade Inflammation in Obese Subjects

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by University of Chile.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Chile
ClinicalTrials.gov Identifier:
NCT01235026
First received: November 1, 2010
Last updated: December 16, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention
Obesity
Diabetes Mellitus Type-2
Insulin Resistance
Metabolic Syndrome
Dietary Supplement: Synbiotic
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Official Title: Impact of the Administration of a Synbiotic on Low Grade Inflammation in Obese Subjects

Resource links provided by NLM:


Further study details as provided by University of Chile:

Primary Outcome Measures:
  • Plasmatic Interleukin-6 (IL-6) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Plasmatic IL-6 will be determined after 6 weeks of administration of the synbiotic and compared with the IL-6 values at baseline.


Secondary Outcome Measures:
  • Plasmatic LPS-binding protein [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 44
Study Start Date: November 2010
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Synbiotic
Dietary Supplement: Synbiotic: combination of the prebiotic "Oligofructose" with the probiotic "Bifidobacterium animalis subsp. lactis Bb12"
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.
Placebo Comparator: Placebo
Dietary supplement: placebo: maltodextrin
Dietary Supplement: Placebo
6g of maltodextrin, twice a day for 6 weeks.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01235026

Contacts
Contact: Martin Gotteland, PhD 56-2-9781471 mgottela@inta.cl

Locations
Chile
Institute of Nutrition and Food Technology (INTA), University of Chile Recruiting
Santiago, Chile
Principal Investigator: Martin Gotteland, PhD         
Sponsors and Collaborators
University of Chile
  More Information

Publications:
Responsible Party: Martin Gotteland, University of Chile
ClinicalTrials.gov Identifier: NCT01235026     History of Changes
Other Study ID Numbers: Fondecyt-1080519
Study First Received: November 1, 2010
Last Updated: December 16, 2010
Health Authority: Chile: Comisión Nacional de Investigación Científica y Tecnológica

Keywords provided by University of Chile:
Obesity
Type-2 Diabetes
Metabolic syndrome
Low grade inflammation
Metabolic endotoxinemia
Insulin resistance
Lipopolysaccharide
LPS-binding protein
sCD14
Synbiotic
Oligofructose
Bifidobacterium animalis subsp. lactis Bb12
probiotic
Prebiotic

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Inflammation
Insulin Resistance
Obesity
Metabolic Syndrome X
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Hyperinsulinism
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014