The Effect of Probiotics on Obesity. Metabolic Endotoxemia and Inflammation

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Probiotane

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Arab Emirates
  • Sharjah, United Arab Emirates, P.O.Box 27272
    • Sondos Harfil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Sharjah
• Collaborators: Universiti Sains Malaysia
• Investigators: Study Chair: Dr. Raed AbuOdeh, PhD, University of Sharjah

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): May 19, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: March 11, 2019
• First Submitted That Met QC Criteria: March 18, 2019
• First Posted (Actual): March 21, 2019

Study Record Updates

• Last Update Posted (Actual): June 8, 2021
• Last Update Submitted That Met QC Criteria: June 3, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Infections; Systemic Inflammatory Response Syndrome; Sepsis; Insulin Resistance; Hyperinsulinism; Bacteremia; Toxemia; Inflammation; Metabolic Syndrome; Endotoxemia
• Other Study ID Numbers: REC-18-05-23-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All information and data will be shared with Dr. Raed AbuOdeh and all the coinvestigators
• IPD Sharing Time Frame: All information will be available during and after the completion of the study for one year.
• IPD Sharing Access Criteria: Soft copy
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No