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Completed

NCT Number: NCT03883685

The Effect of Probiotics on Obesity. Metabolic Endotoxemia and Inflammation

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.

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Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sondos Harfil

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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotane

Dietary Supplement

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

Placebo

Dietary Supplement

Placebo

Primary outcomes

  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,

Sponsors and collaborators

Lead sponsor

University of Sharjah

Other

Collaborators

  • Universiti Sains Malaysia

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 21, 2019
Registry last updated
Jun 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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