Clinical trial NCT03883685: 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
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: University of Sharjah
Sponsor class: OTHER
Collaborators: name: Universiti Sains Malaysia
First posted: 2019-03-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: 80 participants characterized with obesity will be assessed for endotoxemia using LAL Chromogenic Endpoint Assay
timeFrame: 8 weeks
measure: 80 participants characterized with obesity will be assessed for body mass index (BMI) before and after the intervention period
timeFrame: 8 weeks
measure: Lipopolysacharide binding protein (LBP) will be assessed in the participants before and after intervention period.
timeFrame: 8 weeks
measure: IL-6 serum will be assessed in participants before and after the intervention.
timeFrame: 8 weeks
measure: hs-CRP serum level will be assessed in participants before and after the intervention
timeFrame: 8 weeke
measure: TNF-alpha serum level will be assessed in participants before and after the intervention
timeFrame: 8 weeks
measure: Lipid profile will be assayed for all participants before and after the intervention
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sharjah
country: United Arab Emirates
facility: Sondos Harfil
Study officials:
affiliation: University of Sharjah
name: Dr. Raed AbuOdeh, PhD
role: STUDY_CHAIR
References: