The Effect of Probiotics on Obesity. Metabolic Endotoxemia and Inflammation

Not Applicable

Completed

• Conditions: Metabolic Syndrome
• Interventions: Dietary Supplement: Probiotane; Dietary Supplement: Placebo

• Registration Number: NCT03883685
• Lead Sponsor: University of Sharjah

Brief 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.

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-03-11
• Study First Submitted QC: 2019-03-18
• Study First Posted: 2019-03-21
• Primary Completion: 2019-05-19
• Study Completion: 2019-09-01
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-03
• Last Update Posted: 2021-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental group	Probiotane	40 subjects will be randomly allocated to receive probiotics pills for consecutive 8 weeks.
Control group	Placebo	40 subjects will be randomly allocated to receive placebo pills for consecutive 8 weeks.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Sondos Harfil; 🇦🇪 Sharjah, United Arab Emirates