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The Effect of Probiotics on Obesity. Metabolic Endotoxemia and Inflammation

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ClinicalTrials.gov Identifier: NCT03883685
Recruitment Status : Completed
First Posted : March 21, 2019
Last Update Posted : June 8, 2021
Sponsor:
Collaborator:
Universiti Sains Malaysia
Information provided by (Responsible Party):
Sondos Harfil, University of Sharjah

Study Description
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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.


Condition or disease Intervention/treatment Phase
Metabolic Syndrome Dietary Supplement: Probiotane Dietary Supplement: Placebo Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care 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.
Primary Purpose: Prevention
Official Title: The Effect of Probiotics on Obesity. Metabolic Endotoxemia and Inflammation
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : May 19, 2019
Actual Study Completion Date : September 1, 2019
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 80 participants characterized with obesity will be assessed for endotoxemia using LAL Chromogenic Endpoint Assay [ Time Frame: 8 weeks ]
    Estimate the serum levels of LPS (EU/ml) before and after intervention period.

  2. 80 participants characterized with obesity will be assessed for body mass index (BMI) before and after the intervention period [ Time Frame: 8 weeks ]
    BMI ( kg/m2)

  3. Lipopolysacharide binding protein (LBP) will be assessed in the participants before and after intervention period. [ Time Frame: 8 weeks ]
    LBP plasma level (ng/ml) will be assayed using ELISA technique

  4. IL-6 serum will be assessed in participants before and after the intervention. [ Time Frame: 8 weeks ]
    IL-6 serum will be assayed using ELISA

  5. hs-CRP serum level will be assessed in participants before and after the intervention [ Time Frame: 8 weeke ]
    hs-CRP will be assayed using immunoturbidimetry (ITM)

  6. TNF-alpha serum level will be assessed in participants before and after the intervention [ Time Frame: 8 weeks ]
    TNF-alpha will be assayed using ELISA technique

  7. Lipid profile will be assayed for all participants before and after the intervention [ Time Frame: 8 weeks ]
    measurement of serum levels of TG, HDL,LDL,


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03883685


Locations
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United Arab Emirates
Sondos Harfil
Sharjah, United Arab Emirates, P.O.Box 27272
Sponsors and Collaborators
University of Sharjah
Universiti Sains Malaysia
Investigators
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Study Chair: Dr. Raed AbuOdeh, PhD University of Sharjah
More Information
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Responsible Party: Sondos Harfil, lecturer, University of Sharjah
ClinicalTrials.gov Identifier: NCT03883685    
Other Study ID Numbers: REC-18-05-23-01
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: June 8, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All information and data will be shared with Dr. Raed AbuOdeh and all the coinvestigators
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: All information will be available during and after the completion of the study for one year.
Access Criteria: Soft copy

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endotoxemia
Metabolic Syndrome
Inflammation
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
 Metabolic Diseases
Bacteremia
Sepsis
Infections
Toxemia
Systemic Inflammatory Response Syndrome