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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01235026 |
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Date of registration:
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01/11/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Synbiotics and Low Grade Inflammation in Obese Subjects
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Scientific title:
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Impact of the Administration of a Synbiotic on Low Grade Inflammation in Obese Subjects |
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Date of first enrolment:
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November 2010 |
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Target sample size:
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44 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01235026 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science
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Phase:
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N/A
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Countries of recruitment
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Chile
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Contacts
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Name:
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Martin Gotteland, PhD |
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Address:
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Telephone:
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56-2-9781471 |
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Email:
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mgottela@inta.cl |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
20 Years
Age maximum:
50 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus Type-2
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Metabolic Syndrome
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Obesity
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Insulin Resistance
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Intervention(s)
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Dietary Supplement: Synbiotic
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Dietary Supplement: Placebo
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Primary Outcome(s)
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Plasmatic Interleukin-6 (IL-6)
[Time Frame: 6 weeks]
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Secondary Outcome(s)
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Plasmatic LBP
[Time Frame: 10 weeks]
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Lipid profile
[Time Frame: 10 weeks]
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Glucose tolerance curve
[Time Frame: 10 weeks]
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glucose tolerance curve
[Time Frame: 6 weeks]
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Plasmatic sCD14
[Time Frame: 6 weeks]
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Plasmatic LPS-binding protein
[Time Frame: 6 weeks]
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plasmatic ultrasensitive C-Reactive Protein
[Time Frame: 6 weeks]
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Plasmatic usCRP
[Time Frame: 10 weeks]
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Plasmatic IL-6
[Time Frame: 10 weeks]
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Lipid profile
[Time Frame: 6 weeks]
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Plasmatic sCD14
[Time Frame: 10 weeks]
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Secondary ID(s)
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Fondecyt-1080519
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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