Trial | NCT03883685  Report issue

Official Title

The Effect of Probiotics on Obesity. Metabolic Endotoxemia and Inflammation

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    80
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.
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 Started
Jan 01
2019
Primary Completion
May 19
2019
Study Completion
Sep 01
2019
Last Update
Jun 08
2021

Dietary Supplement Probiotane [Lactobacillus acidophilus, lactobacillus casei, lactobacillus rhamnosus]

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

Dietary Supplement Placebo

Placebo

experimental group Experimental

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

Control group Placebo Comparator

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

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
No Results Posted