The Effect of Probiotics on Obesity. Metabolic Endotoxemia and Inflammation
Primary Purpose
Metabolic Syndrome
Status
Completed
Phase
Not Applicable
Locations
United Arab Emirates
Study Type
Interventional
Intervention
Probiotane
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Metabolic Syndrome
Eligibility Criteria
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
Sites / Locations
- Sondos Harfil
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
experimental group
Control group
Arm Description
40 subjects will be randomly allocated to receive probiotics pills for consecutive 8 weeks.
40 subjects will be randomly allocated to receive placebo pills for consecutive 8 weeks.
Outcomes
Primary Outcome Measures
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.
80 participants characterized with obesity will be assessed for body mass index (BMI) before and after the intervention period
BMI ( kg/m2)
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
IL-6 serum will be assessed in participants before and after the intervention.
IL-6 serum will be assayed using ELISA
hs-CRP serum level will be assessed in participants before and after the intervention
hs-CRP will be assayed using immunoturbidimetry (ITM)
TNF-alpha serum level will be assessed in participants before and after the intervention
TNF-alpha will be assayed using ELISA technique
Lipid profile will be assayed for all participants before and after the intervention
measurement of serum levels of TG, HDL,LDL,
Secondary Outcome Measures
Full Information
NCT ID
NCT03883685
First Posted
March 11, 2019
Last Updated
June 3, 2021
Sponsor
University of Sharjah
Collaborators
Universiti Sains Malaysia
1. Study Identification
Unique Protocol Identification Number
NCT03883685
Brief Title
The Effect of Probiotics on Obesity. Metabolic Endotoxemia and Inflammation
Official Title
The Effect of Probiotics on Obesity. Metabolic Endotoxemia and Inflammation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
May 19, 2019 (Actual)
Study Completion Date
September 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sharjah
Collaborators
Universiti Sains Malaysia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
both drugs pills and placebo pills are provided in identical pharmaceutical shape and packing, and provided by the same manufacturer. Participants is blinded.
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
experimental group
Arm Type
Experimental
Arm Description
40 subjects will be randomly allocated to receive probiotics pills for consecutive 8 weeks.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
40 subjects will be randomly allocated to receive placebo pills for consecutive 8 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotane
Intervention Description
probiotics capsules of blended strains including Lactobacillus acidophilus, L. casei and L. rhamnosus
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
80 participants characterized with obesity will be assessed for endotoxemia using LAL Chromogenic Endpoint Assay
Description
Estimate the serum levels of LPS (EU/ml) before and after intervention period.
Time Frame
8 weeks
Title
80 participants characterized with obesity will be assessed for body mass index (BMI) before and after the intervention period
Description
BMI ( kg/m2)
Time Frame
8 weeks
Title
Lipopolysacharide binding protein (LBP) will be assessed in the participants before and after intervention period.
Description
LBP plasma level (ng/ml) will be assayed using ELISA technique
Time Frame
8 weeks
Title
IL-6 serum will be assessed in participants before and after the intervention.
Description
IL-6 serum will be assayed using ELISA
Time Frame
8 weeks
Title
hs-CRP serum level will be assessed in participants before and after the intervention
Description
hs-CRP will be assayed using immunoturbidimetry (ITM)
Time Frame
8 weeke
Title
TNF-alpha serum level will be assessed in participants before and after the intervention
Description
TNF-alpha will be assayed using ELISA technique
Time Frame
8 weeks
Title
Lipid profile will be assayed for all participants before and after the intervention
Description
measurement of serum levels of TG, HDL,LDL,
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Raed AbuOdeh, PhD
Organizational Affiliation
University of Sharjah
Official's Role
Study Chair
Facility Information:
Facility Name
Sondos Harfil
City
Sharjah
ZIP/Postal Code
P.O.Box 27272
Country
United Arab Emirates
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
The Effect of Probiotics on Obesity. Metabolic Endotoxemia and Inflammation
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