The Effect of Probiotics on Obesity. Metabolic Endotoxemia and Inflammation

NCT03883685 | Completed

• 1 other identifier: REC-18-05-23-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

experimental group

EXPERIMENTAL

40 subjects will be randomly allocated to receive probiotics pills for consecutive 8 weeks.

Dietary Supplement: Probiotane

Control group

PLACEBO COMPARATOR

40 subjects will be randomly allocated to receive placebo pills for consecutive 8 weeks.

Dietary Supplement: Placebo

Interventions

Probiotane DIETARY_SUPPLEMENT

probiotics capsules of blended strains including Lactobacillus acidophilus, L. casei and L. rhamnosus

experimental group

Placebo DIETARY_SUPPLEMENT

Placebo

Control group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Accepts healthy volunteers
• male and female
• age (18 - 55 yrs.)
• living in Dubai or Sharjah.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sharjah: lead
• Universiti Sains Malaysia: collaborator

Study Sites (1)

Sondos Harfil

Sharjah city, P.O.Box 27272, United Arab Emirates

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Dr. Raed AbuOdeh, PhD

  University of Sharjah

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: both drugs pills and placebo pills are provided in identical pharmaceutical shape and packing, and provided by the same manufacturer. Participants is blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: March 21, 2019
• Study Start: January 1, 2019
• Primary Completion: May 19, 2019
• Study Completion: September 1, 2019
• Last Updated: June 8, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: All information will be available during and after the completion of the study for one year.
• Access Criteria: Soft copy

Locations

AE (1)