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| Name | Class |
|---|---|
| Universiti Sains Malaysia | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | 40 subjects will be randomly allocated to receive probiotics pills for consecutive 8 weeks. |
|
| Control group | Placebo Comparator | 40 subjects will be randomly allocated to receive placebo pills for consecutive 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotane | Dietary Supplement | probiotics capsules of blended strains including Lactobacillus acidophilus, L. casei and L. rhamnosus |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Raed AbuOdeh, PhD | University of Sharjah | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sondos Harfil | Sharjah city | P.O.Box 27272 | United Arab Emirates |
All information and data will be shared with Dr. Raed AbuOdeh and all the coinvestigators
All information will be available during and after the completion of the study for one year.
Soft copy
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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both drugs pills and placebo pills are provided in identical pharmaceutical shape and packing, and provided by the same manufacturer. Participants is blinded.
| Placebo | Dietary Supplement | Placebo |
|
| D009750 |
| Nutritional and Metabolic Diseases |