NCT03883685

The Effect of Probiotics on Obesity. Metabolic Endotoxemia and Inflammation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: University of Sharjah · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Metabolic Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotane	probiotics capsules of blended strains including Lactobacillus acidophilus, L. casei and L. rhamnosus
DIETARY_SUPPLEMENT	Placebo	Placebo

Timeline

• Start date: 2019-01-01
• Primary completion: 2019-05-19
• Completion: 2019-09-01
• First posted: 2019-03-21
• Last updated: 2021-06-08

Locations

1 site across 1 country: United Arab Emirates