Clinical trial NCT04086173: Probiotics on Body Composition and Insulin Resistance in Patients With Obesity and Its Association With Gut Microbiota
Official title: Effects of Probiotic Treatment on Body Composition and Insulin Resistance in Patients With Obesity Grade II and III and Its Association With Changes in Intestinal Microbiota
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Insulin Resistance
Microbial Colonization
Lead sponsor: Hospital General de México Dr. Eduardo Liceaga
Sponsor class: OTHER_GOV
Collaborators: name: Italmex Pharma
name: Medix Farma
name: National Polytechnic Institute, Mexico
First posted: 2019-09-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blinded randomized placebo-controlled clinical assay
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to evaluate the modifications in body composition and insulin resistance state in patients with grade II and III obesity included in an interventional lifestyle changes program and treated with probiotics (1 x 1011 CFU) or placebo for 16 weeks and its associations with intestinal microbiota behaviour

Detailed description: A randomized placebo-controlled clinical trial will take place in which both arms will be included in an interventional lifestyle changes program at the Clinic for Integral Treatment of patients with Diabetes and Obesity. The study group will be treated with probiotics (1 x 1011 CFU) for 16 weeks and will be compared to a control group who will receive placebo.

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.

Eligibility criteria: Inclusion Criteria:

* Patients with grade II y III obesity (IMC \> or = 35 Kg/m2), who receive the initial evaluation at the Integral Attention Clinic for Diabetes and Obesity at Hospital General de México
* Patients who signed informed consent.

Exclusion Criteria:

* Diabetes mellitus 2
* 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).

Primary outcomes:
measure: Changes in fat mass in patients with obesity
timeFrame: 16 weeks
measure: Changes in fat percentage in patients with obesity
timeFrame: 16 weeks
measure: Changes in body mass index in patients with obesity
timeFrame: 16 weeks
measure: Changes in weight in patients with obesity
timeFrame: 16 weeks
measure: Changes in lean body mass in patients with obesity
timeFrame: 16 weeks
measure: Changes in Insulin resistance indexes
timeFrame: 16 weeks
measure: Changes in Insulin sensitivity indexes
timeFrame: 16 weeks
measure: Changes in Quicki insulin sensitivity index
timeFrame: 16 weeks
Secondary outcomes:
measure: Changes in glucose tolerance test
timeFrame: 16 weeks
measure: Changes in glycated haemoglobin
timeFrame: 16 weeks
measure: Changes in triglycerides
timeFrame: 16 weeks
measure: Changes in total cholesterol
timeFrame: 16 weeks
measure: Changes in HDL cholesterol
timeFrame: 16 weeks
measure: Changes in LDL cholesterol
timeFrame: 16 weeks
measure: Changes in uric acid
timeFrame: 16 weeks
measure: Changes in aspartate aminotransferase
timeFrame: 16 weeks
measure: Changes in alanine aminotransferase
timeFrame: 16 weeks
measure: Changes in leptin
timeFrame: 16 weeks
Other outcomes:
measure: Changes in microRNAs
timeFrame: 16 weeks
measure: Compare threshold for basic tastes
timeFrame: 16 weeks
measure: Changes in intestinal microbiota
timeFrame: 16 weeks
Locations:
city: Mexico City
country: Mexico
facility: Hospital General de México "Dr. Eduardo Liceaga"
Study officials:
affiliation: Hospital General de Mexico Eduardo Liceaga
name: Nayely Garibay-Nieto, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.