Probiotics and Endotoxemia
PROMS-01
1 other identifier
interventional
90
1 country
1
Brief Summary
The purpose of this study is to determine whether probiotic treatment of overweight volunteers consuming high fat diet is able to reduce plasma lipopolysaccharide concentration.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 24, 2010
CompletedFirst Posted
Study publicly available on registry
August 6, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedDecember 9, 2014
December 1, 2014
7 months
May 24, 2010
December 8, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Level of plasma endotoxin (plasma levels of lipopolysaccharides) in the volunteers before and after the 12 week intervention
Quantitative, kinetic assay for the detection of gram negative bacterial endotoxin (lipopolysaccharide) is used to test whether the probiotic intervention can reduce plasma endotoxin levels (IU/ml) compared to the baseline.
12 weeks
Secondary Outcomes (8)
Volunteer weight before and after the 12 week intervention.
12 weeks
Volunteer waist perimeter before and after the 12 week intervention
12 weeks
Insulin resistance (HOMA-IR index), glycemia, insulinemia and glycated hemoglobin in the volunteers before and after the 12 week intervention
12 weeks
Brachial blood pressure of the volunteers before and after the 12 week intervention.
12 weeks
Blood lipids in the volunteers before and after the 12 week intervention.
12 weeks
- +3 more secondary outcomes
Study Arms (2)
Probiotic
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Probiotic placebo controlled intervention
Eligibility Criteria
You may qualify if:
- Body mass index ≥ 27 kg/m2; above 18 years of age
- Used to eat high fat diet (more than 40% of total energy intake)
You may not qualify if:
- Treated cardiovascular risk factors, treated hypertension, treated dyslipidemia, treated diabetes; Known diabetes, hypertension, dyslipidemia
- Severe illnesses
- Artificial heart valve
- Immunosuppression
- Regular consumption of probiotics
- History of bariatric surgery
- Consumption or wish to consume Orlistat
- Participation in other research
- Pregnancy or wishing/trying to get pregnant
- Inability to follow protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daniscolead
Study Sites (1)
CHU Toulouse Hospital
Toulouse, Cedex 9, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2010
First Posted
August 6, 2010
Study Start
May 1, 2010
Primary Completion
December 1, 2010
Study Completion
May 1, 2011
Last Updated
December 9, 2014
Record last verified: 2014-12