Metabolic SyndromeNCT03883685
The Effect of Probiotics on Obesity. Metabolic Endotoxemia and Inflammation
A study testing Probiotane in people with Metabolic Syndrome, run by University of Sharjah at 1 site in United Arab Emirates.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Probiotane
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 1 Jan 2019to 1 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Accepts healthy volunteers
- 250 male and female
- age (18 - 55 yrs.)
- living in Dubai or Sharjah.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
Sondos Harfil
Sharjah city, P.O.Box 27272
About this study
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.
Read the 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.
- Conditions
- Metabolic Syndrome
- Being tested
- Probiotane, Placebo
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbiotaneDietary supplement
probiotics capsules of blended strains including Lactobacillus acidophilus, L. casei and L. rhamnosus
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | 40 subjects will be randomly allocated to receive probiotics pills for consecutive 8 weeks. Receives: Dietary Supplement: Probiotane |
| Control group | Placebo comparator | 40 subjects will be randomly allocated to receive placebo pills for consecutive 8 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
80 participants characterized with obesity will be assessed for body mass index (BMI) before and after the intervention period
BMI ( kg/m2)
Measured: 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
Measured: 8 weeks
IL-6 serum will be assessed in participants before and after the intervention.
IL-6 serum will be assayed using ELISA
Measured: 8 weeks
hs-CRP serum level will be assessed in participants before and after the intervention
hs-CRP will be assayed using immunoturbidimetry (ITM)
Measured: 8 weeke
TNF-alpha serum level will be assessed in participants before and after the intervention
TNF-alpha will be assayed using ELISA technique
Measured: 8 weeks
Lipid profile will be assayed for all participants before and after the intervention
measurement of serum levels of TG, HDL,LDL,
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start1 Jan 2019
- Primary completion19 May 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sharjah
- Sponsor type
- University, hospital or other
- Collaborators
- Universiti Sains Malaysia
- Responsible party
- Principal investigator, Sondos Harfil, University of Sharjah
- Investigators
- Dr. Raed AbuOdeh, PhD, Study chair, University of Sharjah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883685
- Sponsor's protocol ID
- REC-18-05-23-01
- Status last verified
- Jun 2021
- First submitted
- 11 Mar 2019
- Last updated
- 8 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All information and data will be shared with Dr. Raed AbuOdeh and all the coinvestigators
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Probiotics on Obesity. Metabolic Endotoxemia and Inflammation
- ClinicalTrials.gov ID
- NCT03883685
- Acronym / sponsor ID
- REC-18-05-23-01
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of SharjahUniversity, hospital or other
- Collaborators
- Universiti Sains Malaysia
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 19 May 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 21 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Dietary Supplement: Probiotane40 subjects will be randomly allocated to receive probiotics pills for consecutive 8 weeks. |
| Control group | Placebo comparator | Dietary Supplement: Placebo40 subjects will be randomly allocated to receive placebo pills for consecutive 8 weeks. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Accepts healthy volunteers
- 250 male and female
- age (18 - 55 yrs.)
- living in Dubai or Sharjah.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotaneprobiotics capsules of blended strains including Lactobacillus acidophilus, L. casei and L. rhamnosus | Dietary supplement | experimental group |
| PlaceboPlacebo | Dietary supplement | Control group |
Primary outcome
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.
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)
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
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
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)
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
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,
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Individual participant dataSharing planned: Yes. All information and data will be shared with Dr. Raed AbuOdeh and all the coinvestigators
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Raed AbuOdeh, PhD study chair
University of Sharjah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotane in people with Metabolic Syndrome, run by University of Sharjah at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
80 participants characterized with obesity will be assessed for endotoxemia using LAL Chromogenic Endpoint Assay (time frame: 8 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2021; AzTrials last refreshed its copy on 8 Nov 2026.