The Effect of Probiotics on Obesity. Metabolic Endotoxemia and Inflammation

Metabolic Syndrome Clinical Trial

Official title:

The Effect of Probiotics on Obesity. Metabolic Endotoxemia and Inflammation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03883685
• Other study ID #: REC-18-05-23-01
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: September 1, 2019

Study information

• Verified date: June 2021
• Source: University of Sharjah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 1, 2019
• Est. primary completion date: May 19, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Endotoxemia
• Inflammation
• Metabolic Syndrome

Intervention

Dietary Supplement:
• Probiotane
probiotics capsules of blended strains including Lactobacillus acidophilus, L. casei and L. rhamnosus
• Placebo
Placebo

Locations

Country	Name	City	State
United Arab Emirates	Sondos Harfil	Sharjah

Sponsors (2)

Lead Sponsor	Collaborator
University of Sharjah	Universiti Sains Malaysia

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	80 participants characterized with obesity will be assessed for body mass index (BMI) before and after the intervention period	BMI ( kg/m2)	8 weeks
Primary	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
Primary	IL-6 serum will be assessed in participants before and after the intervention.	IL-6 serum will be assayed using ELISA	8 weeks
Primary	hs-CRP serum level will be assessed in participants before and after the intervention	hs-CRP will be assayed using immunoturbidimetry (ITM)	8 weeke
Primary	TNF-alpha serum level will be assessed in participants before and after the intervention	TNF-alpha will be assayed using ELISA technique	8 weeks
Primary	Lipid profile will be assayed for all participants before and after the intervention	measurement of serum levels of TG, HDL,LDL,	8 weeks