Status:
UNKNOWN
Synbiotics and Low Grade Inflammation in Obese Subjects
Lead Sponsor:
University of Chile
Conditions:
Obesity
Diabetes Mellitus Type-2
Eligibility:
All Genders
20-50 years
Phase:
NA
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 gluco...
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 de...
Eligibility Criteria
Inclusion
- BMI \> 30
- Non-smokers
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2011
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01235026
Start Date
November 1 2010
End Date
January 1 2011
Last Update
December 17 2010
Active Locations (1)
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1
Institute of Nutrition and Food Technology (INTA), University of Chile
Santiago, Chile