- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04086173
Probiotics on Body Composition and Insulin Resistance in Patients With Obesity and Its Association With Gut Microbiota
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nayely Garibay, MSc
- Phone Number: +525546037000
- Email: gngaribay@hotmail.com
Study Contact Backup
- Name: Alejandro Velasco, MSc
- Phone Number: +525541449172
- Email: jano_vm@yahoo.com
Study Locations
-
-
-
Mexico City, Mexico
- Recruiting
- Hospital General de México "Dr. Eduardo Liceaga"
-
Contact:
- Alejandro Velasco Medina, MSc
- Phone Number: 5541449172
- Email: jano_vam@yahoo.com.mx
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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 will be administered at night and will consist of 4 capsules
|
Placebo Comparator: 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in fat mass in patients with obesity
Time Frame: 16 weeks
|
Evaluate changes in fat mass kilograms after probiotics treatment in patients with obesity, by bioelectrical impedance analysis
|
16 weeks
|
Changes in fat percentage in patients with obesity
Time Frame: 16 weeks
|
Evaluate changes in fat percentage after probiotics treatment in patients with obesity, by bioelectrical impedance analysis
|
16 weeks
|
Changes in body mass index in patients with obesity
Time Frame: 16 weeks
|
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
|
Changes in weight in patients with obesity
Time Frame: 16 weeks
|
Evaluate changes in weight kilograms after probiotics treatment in patients with obesity
|
16 weeks
|
Changes in lean body mass in patients with obesity
Time Frame: 16 weeks
|
Evaluate changes in lean body mass kilograms after probiotics treatment in patients with obesity, by bioelectrical impedance analysis
|
16 weeks
|
Changes in Insulin resistance indexes
Time Frame: 16 weeks
|
Modification in HOMA index after probiotics treatment in patients with obesity
|
16 weeks
|
Changes in Insulin sensitivity indexes
Time Frame: 16 weeks
|
Modification in insulin sensitivity index after probiotics treatment in patients with obesity
|
16 weeks
|
Changes in Quicki insulin sensitivity index
Time Frame: 16 weeks
|
Modification in Quicki index after probiotics treatment in patients with obesity
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in glucose tolerance test
Time Frame: 16 weeks
|
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
|
Changes in glycated haemoglobin
Time Frame: 16 weeks
|
Evaluate changes in percentage glycated haemoglobin after treatment with probiotics in patients with obesity.
Obtain by capillary electrophoresis system
|
16 weeks
|
Changes in triglycerides
Time Frame: 16 weeks
|
Evaluate changes in triglycerides (mg/dL) after treatment with probiotics in patients with obesity
|
16 weeks
|
Changes in total cholesterol
Time Frame: 16 weeks
|
Evaluate changes in total cholesterol (mg/dL) after treatment with probiotics in patients with obesity
|
16 weeks
|
Changes in HDL cholesterol
Time Frame: 16 weeks
|
Evaluate changes in HDL cholesterol (mg/dL) after treatment with probiotics in patients with obesity
|
16 weeks
|
Changes in LDL cholesterol
Time Frame: 16 weeks
|
Evaluate changes in LDL cholesterol (mg/dL) after treatment with probiotics in patients with obesity
|
16 weeks
|
Changes in uric acid
Time Frame: 16 weeks
|
Evaluate changes in uric acid (mg/dL) after treatment with probiotics in patients with obesity
|
16 weeks
|
Changes in aspartate aminotransferase
Time Frame: 16 weeks
|
Evaluate changes in aspartate aminotransferase (U/L) after treatment with probiotics in patients with obesity
|
16 weeks
|
Changes in alanine aminotransferase
Time Frame: 16 weeks
|
Evaluate changes in alanine aminotransferase (U/L) after treatment with probiotics in patients with obesity
|
16 weeks
|
Changes in leptin
Time Frame: 16 weeks
|
Evaluate changes in leptin (ng/mL) after treatment with probiotics in patients with obesity
|
16 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in microRNAs
Time Frame: 16 weeks
|
Evaluate changes in miR-133 and miR-27 after treatment with probiotics in patients with obesity
|
16 weeks
|
Compare threshold for basic tastes
Time Frame: 16 weeks
|
Evaluate differences in basic taste thresholds (sour, salty, sweet and bitter) after treatment with probiotics in patients with obesity
|
16 weeks
|
Changes in intestinal microbiota
Time Frame: 16 weeks
|
Evaluate differences in intestinal microbiota behaviour after treatment with probiotics in patients with obesity
|
16 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Nayely Garibay-Nieto, MSc, Hospital General de Mexico Eduardo Liceaga
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00000
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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