Probiotics on Body Composition and Insulin Resistance in Patients With Obesity and Its Association With Gut Microbiota
NCT ID: NCT04086173
Last Updated: 2019-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2018-03-01
2020-07-31
Brief Summary
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Detailed Description
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Changes in body composition (weight, BMI, fat percentage, fat mass, lean body mass) and insulin resistance indexes (HOMA, insulin sensitivity index and Quicki) will be evaluated in patients with obesity receiving probiotics (1 x 1011 CFU) for 16 weeks, and compared to a placebo group.
Changes in metabolic profile (glucose tolerance test, glycosylated haemoglobin, lipid profile, leptin and transaminases) in patients with obesity receiving probiotics (1 x 1011 CFU) for 16 weeks, and compared to a placebo group.
Changes in microRNAs profile (miR-133 and miR-27 in patients with obesity receiving probiotics (1 x 1011 CFU) for 16 weeks, and compared to a placebo group.
The threshold for basic tastes will be evaluated (salted, bitter, acid, sweet) and will be evaluated in those patients receiving probiotics (1 x 1011 CFU) for 16 weeks, and compared to the group receiving only placebo.
Changes in intestinal microbiota behaviour will be evaluated in participants with obesity receiving probiotics (1 x 1011 CFU) for 16 weeks, and compared to the group receiving placebo.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Study group
Subjects will be randomly assigned to receive a daily nightly dose (4 capsules) of probiotics for 16 weeks. Probiotics (LACTIPAN®) include 2.5 billion CFU of 6 different strains of live microorganisms, such as Lactobacillus acidophilus (1.0 x 109 CFU), Lactobacillus casei (1.0 x 109 CFU), Lactobacillus rhamnosus (4.4 x 108 CFU), Lactobacillus plantarum (1.76 x 108 CFU), Bifidobacterium infantis (2.76 x 107 CFU), Streptococcus thermophilus (6.66 x 105 CFU) and 50 mg of oligofructose enriched inulin.
Probiotics
Probiotics will be administered at night and will consist of 4 capsules
Control group
Subjects will be randomly assigned to receive a daily nightly dose (4 capsules) of placebo for 16 weeks. Placebo presentation will have the same aspect as those of the probiotic treatment.
Placebo
Placebo
Interventions
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Probiotics
Probiotics will be administered at night and will consist of 4 capsules
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* Patients who signed informed consent.
Exclusion Criteria
* Secondary causes of obesity (hypothyroidism, Cushing syndrome).
* Patients receiving pharmacological treatment that may affect lipid or glucose metabolism.
* Patients who received broad-spectrum antibiotics during the 4 previous weeks.
* Ingestion of products that contain probiotics.
* Relevant changes in diet habits during the 4 previous weeks
* Intestinal Malabsorption disorders ( inflammatory bowel disease, chronic diarrhea, C. difficile infection).
18 Years
64 Years
ALL
No
Sponsors
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Italmex Pharma
UNKNOWN
Medix Farma
UNKNOWN
National Polytechnic Institute, Mexico
OTHER
Hospital General de México Dr. Eduardo Liceaga
OTHER_GOV
Responsible Party
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Nayely Garibay Nieto
Head Child and Adolescent Obesity Clinic
Principal Investigators
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Nayely Garibay-Nieto, MSc
Role: PRINCIPAL_INVESTIGATOR
Hospital General de Mexico Eduardo Liceaga
Locations
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Hospital General de México "Dr. Eduardo Liceaga"
Mexico City, , Mexico
Countries
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Central Contacts
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Facility Contacts
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References
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Banegas JR, Lopez-Garcia E, Gutierrez-Fisac JL, Guallar-Castillon P, Rodriguez-Artalejo F. A simple estimate of mortality attributable to excess weight in the European Union. Eur J Clin Nutr. 2003 Feb;57(2):201-8. doi: 10.1038/sj.ejcn.1601538.
Neish AS. Microbes in gastrointestinal health and disease. Gastroenterology. 2009 Jan;136(1):65-80. doi: 10.1053/j.gastro.2008.10.080. Epub 2008 Nov 19.
Hooper LV, Wong MH, Thelin A, Hansson L, Falk PG, Gordon JI. Molecular analysis of commensal host-microbial relationships in the intestine. Science. 2001 Feb 2;291(5505):881-4. doi: 10.1126/science.291.5505.881.
Jalanka J, Mattila E, Jouhten H, Hartman J, de Vos WM, Arkkila P, Satokari R. Long-term effects on luminal and mucosal microbiota and commonly acquired taxa in faecal microbiota transplantation for recurrent Clostridium difficile infection. BMC Med. 2016 Oct 11;14(1):155. doi: 10.1186/s12916-016-0698-z.
Ley RE, Turnbaugh PJ, Klein S, Gordon JI. Microbial ecology: human gut microbes associated with obesity. Nature. 2006 Dec 21;444(7122):1022-3. doi: 10.1038/4441022a.
Other Identifiers
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00000
Identifier Type: -
Identifier Source: org_study_id
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