The Effect of Probiotics on Obesity. Metabolic Endotoxemia and Inflammation

Study Overview
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Brief Summary
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In spite of the growing evidence for the beneficial effects of probiotics, their anti-obesity effects are not well examined. No previous studies were conducted in this research area in the UAE. Hence, the aims of this study are to 1) Investigate the link between metabolic derangements associated with obesity and levels of LPS and LBP; 2) Study the relatedness of low grade inflammation with the ME; 3) Investigate the food intake assessment; and 4) Investigate the effectiveness of probiotics supplement on the obesity, ME and inflammation. This project will have two phases: 1) a cross-sectional, in which 250 adults will be recruited for the collection of anthropometric measures, food intake, and fasting blood samples to measure serum LPS, LBP, Lipid profile, IR, insulin-like growth factor, hs-CRP, IL-6, and glucose. 2) Intervention phase, in which 50 overweight subjects will be randomly assigned to either receive a daily probiotic (25 subjects) or a placebo capsule (25 subjects) during the intervention period.

Detailed Description
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General Objective: To study the relatedness of obesity, with the associated metabolic endotoxemia and low-grade inflammation, and the effectiveness of probiotics intervention in adults, in UAE. Specific Aims: Investigate the link between metabolic derangements associated with obesity and levels of LPS and LBP among the population in Sharjah, UAE. To examine the associated factors of obesity among the same population, including socio-demographic data, anthropometric measures, body composition analysis, and food frequency assessment. To investigate the correlation of the inflammatory marker Il-6 and hs-CRP to the levels of endotoxemia in lean, overweight and obese subjects. To evaluate the change in endotoxemia, body mass index (BMI) and inflammatory markers, after consumption of probiotics capsules of blended strains of Lactobacillus for 8 consecutive weeks among overweight and obese individuals.

Official Title
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The Effect of Probiotics on Obesity. Metabolic Endotoxemia and Inflammation

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Dietary Supplement: Probiotane
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Accepts healthy volunteers 250 male and female age (18 - 55 yrs.) living in Dubai or Sharjah. Exclusion Criteria: Pregnant breastfeeding or post menopause female individuals with thyroid individuals with liver, kidney or internal organs disorders individuals with signs of hypersensitivity individuals with have known allergy to probiotics, immune-disorder, malignant tumor. individuals with any major surgery during the last 6 months current smokers individuals with, acute illness within 2 weeks before collecting blood samples

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>40 subjects will be randomly allocated to receive probiotics pills for consecutive 8 weeks. | Dietary Supplement: Probiotane<br>* probiotics capsules of blended strains including Lactobacillus acidophilus, L. casei and L. rhamnosus<br>|
| Placebo Comparator: Control group<br>40 subjects will be randomly allocated to receive placebo pills for consecutive 8 weeks. | Dietary Supplement: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 80 participants characterized with obesity will be assessed for endotoxemia using LAL Chromogenic Endpoint Assay | Estimate the serum levels of LPS (EU/ml) before and after intervention period. | 8 weeks | 
| 80 participants characterized with obesity will be assessed for body mass index (BMI) before and after the intervention period | BMI ( kg/m2) | 8 weeks | 
| Lipopolysacharide binding protein (LBP) will be assessed in the participants before and after intervention period. | LBP plasma level (ng/ml) will be assayed using ELISA technique | 8 weeks | 
| IL-6 serum will be assessed in participants before and after the intervention. | IL-6 serum will be assayed using ELISA | 8 weeks | 
| hs-CRP serum level will be assessed in participants before and after the intervention | hs-CRP will be assayed using immunoturbidimetry (ITM) | 8 weeke | 
| TNF-alpha serum level will be assessed in participants before and after the intervention | TNF-alpha will be assayed using ELISA technique | 8 weeks | 
| Lipid profile will be assayed for all participants before and after the intervention | measurement of serum levels of TG, HDL,LDL, | 8 weeks |