Probiotics on Body Composition and Insulin Resistance in Patients With Obesity and Its Association With Gut Microbiota

Obesity Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04086173
• Other study ID #: 00000
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: July 31, 2020

Study information

• Verified date: September 2019
• Source: Hospital General de México Dr. Eduardo Liceaga
• Contact: Nayely Garibay, MSc
• Phone: +525546037000
• Email: gngaribay[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 31, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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).

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Insulin Resistance
• Microbial Colonization
• Obesity

Intervention

Dietary Supplement:
• Probiotics
Probiotics will be administered at night and will consist of 4 capsules

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
Mexico	Hospital General de México "Dr. Eduardo Liceaga"	Mexico City

Sponsors (4)

Lead Sponsor	Collaborator
Hospital General de México Dr. Eduardo Liceaga	Italmex Pharma, Medix Farma, National Polytechnic Institute, Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (5)

Banegas JR, López-García E, Gutiérrez-Fisac JL, Guallar-Castillón P, Rodríguez-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. — View 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. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in microRNAs	Evaluate changes in miR-133 and miR-27 after treatment with probiotics in patients with obesity	16 weeks
Other	Compare threshold for basic tastes	Evaluate differences in basic taste thresholds (sour, salty, sweet and bitter) after treatment with probiotics in patients with obesity	16 weeks
Other	Changes in intestinal microbiota	Evaluate differences in intestinal microbiota behaviour after treatment with probiotics in patients with obesity	16 weeks
Primary	Changes in fat mass in patients with obesity	Evaluate changes in fat mass kilograms after probiotics treatment in patients with obesity, by bioelectrical impedance analysis	16 weeks
Primary	Changes in fat percentage in patients with obesity	Evaluate changes in fat percentage after probiotics treatment in patients with obesity, by bioelectrical impedance analysis	16 weeks
Primary	Changes in body mass index in patients with obesity	Evaluate changes in body mass index after probiotics treatment in patients with obesity. Calculated with the weight in kilograms divided by the square of the height in meters	16 weeks
Primary	Changes in weight in patients with obesity	Evaluate changes in weight kilograms after probiotics treatment in patients with obesity	16 weeks
Primary	Changes in lean body mass in patients with obesity	Evaluate changes in lean body mass kilograms after probiotics treatment in patients with obesity, by bioelectrical impedance analysis	16 weeks
Primary	Changes in Insulin resistance indexes	Modification in HOMA index after probiotics treatment in patients with obesity	16 weeks
Primary	Changes in Insulin sensitivity indexes	Modification in insulin sensitivity index after probiotics treatment in patients with obesity	16 weeks
Primary	Changes in Quicki insulin sensitivity index	Modification in Quicki index after probiotics treatment in patients with obesity	16 weeks
Secondary	Changes in glucose tolerance test	Evaluate changes in glucose tolerance test after treatment with probiotics in patients with obesity. By using plasma concentrations of insulin and glucose obtained during 120 min of a standard (75 g glucose).	16 weeks
Secondary	Changes in glycated haemoglobin	Evaluate changes in percentage glycated haemoglobin after treatment with probiotics in patients with obesity. Obtain by capillary electrophoresis system	16 weeks
Secondary	Changes in triglycerides	Evaluate changes in triglycerides (mg/dL) after treatment with probiotics in patients with obesity	16 weeks
Secondary	Changes in total cholesterol	Evaluate changes in total cholesterol (mg/dL) after treatment with probiotics in patients with obesity	16 weeks
Secondary	Changes in HDL cholesterol	Evaluate changes in HDL cholesterol (mg/dL) after treatment with probiotics in patients with obesity	16 weeks
Secondary	Changes in LDL cholesterol	Evaluate changes in LDL cholesterol (mg/dL) after treatment with probiotics in patients with obesity	16 weeks
Secondary	Changes in uric acid	Evaluate changes in uric acid (mg/dL) after treatment with probiotics in patients with obesity	16 weeks
Secondary	Changes in aspartate aminotransferase	Evaluate changes in aspartate aminotransferase (U/L) after treatment with probiotics in patients with obesity	16 weeks
Secondary	Changes in alanine aminotransferase	Evaluate changes in alanine aminotransferase (U/L) after treatment with probiotics in patients with obesity	16 weeks
Secondary	Changes in leptin	Evaluate changes in leptin (ng/mL) after treatment with probiotics in patients with obesity	16 weeks