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| Name | Class |
|---|---|
| Italmex Pharma | UNKNOWN |
| Medix Farma | UNKNOWN |
| National Polytechnic Institute, Mexico | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | 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. |
|
| Control group | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotics | Dietary Supplement | Probiotics will be administered at night and will consist of 4 capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Changes in weight in patients with obesity | Evaluate changes in weight kilograms after probiotics treatment in patients with obesity | 16 weeks |
| 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 |
| Changes in Insulin resistance indexes | Modification in HOMA index after probiotics treatment in patients with obesity | 16 weeks |
| Changes in Insulin sensitivity indexes | Modification in insulin sensitivity index after probiotics treatment in patients with obesity |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Changes in glycated haemoglobin |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in microRNAs | Evaluate changes in miR-133 and miR-27 after treatment with probiotics in patients with obesity | 16 weeks |
| Compare threshold for basic tastes | Evaluate differences in basic taste thresholds (sour, salty, sweet and bitter) after treatment with probiotics in patients with obesity |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nayely Garibay, MSc | Contact | +525546037000 | gngaribay@hotmail.com | |
| Alejandro Velasco, MSc | Contact | +525541449172 | jano_vm@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Nayely Garibay-Nieto, MSc | Hospital General de Mexico Eduardo Liceaga | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General de México "Dr. Eduardo Liceaga" | Recruiting | Mexico City | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12571650 | Background | 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. | |
| 19026645 | Background | 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. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D007333 | Insulin Resistance |
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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Double-blinded randomized placebo-controlled clinical assay
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Neither the participant nor the Care provider administrating treatment will know the type of treatment.
| Placebo | Other | Placebo |
|
| 16 weeks |
| Changes in Quicki insulin sensitivity index | Modification in Quicki index after probiotics treatment in patients with obesity | 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 | Evaluate changes in triglycerides (mg/dL) after treatment with probiotics in patients with obesity | 16 weeks |
| Changes in total cholesterol | Evaluate changes in total cholesterol (mg/dL) after treatment with probiotics in patients with obesity | 16 weeks |
| Changes in HDL cholesterol | Evaluate changes in HDL cholesterol (mg/dL) after treatment with probiotics in patients with obesity | 16 weeks |
| Changes in LDL cholesterol | Evaluate changes in LDL cholesterol (mg/dL) after treatment with probiotics in patients with obesity | 16 weeks |
| Changes in uric acid | Evaluate changes in uric acid (mg/dL) after treatment with probiotics in patients with obesity | 16 weeks |
| Changes in aspartate aminotransferase | Evaluate changes in aspartate aminotransferase (U/L) after treatment with probiotics in patients with obesity | 16 weeks |
| Changes in alanine aminotransferase | Evaluate changes in alanine aminotransferase (U/L) after treatment with probiotics in patients with obesity | 16 weeks |
| Changes in leptin | Evaluate changes in leptin (ng/mL) after treatment with probiotics in patients with obesity | 16 weeks |
| 16 weeks |
| Changes in intestinal microbiota | Evaluate differences in intestinal microbiota behaviour after treatment with probiotics in patients with obesity | 16 weeks |
| 11157169 | Background | 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. |
| 27724956 | Background | 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. |
| 17183309 | Background | 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. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D019602 |
| Food and Beverages |