Metabolic EndotoxemiaPROMS-01NCT01176942
Probiotics and Endotoxemia
A study testing Probiotic bacterium Bifidobacterium lactis in people with Metabolic Endotoxemia and Metabolic Syndrome, run by Danisco at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolic Endotoxemia, Metabolic Syndrome
- What is being tested?
- Probiotic bacterium Bifidobacterium lactis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- May 2010to May 2011
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index ≥ 27 kg/m2; above 18 years of age
- Used to eat high fat diet (more than 40% of total energy intake)
Who cannot join
- 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
Show all 10Show fewer
- Consumption or wish to consume Orlistat
- Participation in other research
- Pregnancy or wishing/trying to get pregnant
- Inability to follow protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Probiotics and Endotoxemia in Humans
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.
- Conditions
- Metabolic Endotoxemia, Metabolic Syndrome
- Being tested
- Probiotic bacterium Bifidobacterium lactis
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic bacterium Bifidobacterium lactisDietary supplement
Also called Bifidobacterium animalis subsp. lactis
Probiotic placebo controlled intervention
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Not described Receives: Dietary Supplement: Probiotic bacterium Bifidobacterium lactis |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Probiotic bacterium Bifidobacterium lactis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (8)
Volunteer weight before and after the 12 week intervention.
Measured: 12 weeks
Volunteer waist perimeter before and after the 12 week intervention
Measured: 12 weeks
Insulin resistance (HOMA-IR index), glycemia, insulinemia and glycated hemoglobin in the volunteers before and after the 12 week intervention
Insulin resistance (IR) will be quantified in the non-diabetic adults using the HOMA-IR index calculated as the product of fasting plasma insulin (in microunits per milliliter) and fasting plasma glucose (in millimoles per liter), divided by 22.5. Higher HOMA values indicate higher IR. Glycated haemoglobin is used as a biological measure indicator of blood glucose concentration over 3 months.
Measured: 12 weeks
Brachial blood pressure of the volunteers before and after the 12 week intervention.
Measured: 12 weeks
Blood lipids in the volunteers before and after the 12 week intervention.
Plasma total cholesterol and triglycerides are measured by enzymatic methods. High-density lipoprotein (HDL) cholesterol is measured in the supernatant after sodium phosphotungstate/magnesium chloride precipitation. Low-density lipoprotein (LDL) cholesterol is determined by the Friedewald formula.
Measured: 12 weeks
Serum inflammatory markers of volunteers before and after the 12 week intervention.
IL-6 (Interleukin-6) level is measured by an immunoenzymatic method, sCD14 is measured using an immuno-enzymatic method, and C reactive protein (CRP) levels is measured by an immunonephelemetric method.
Measured: 12 weeks
Intestinal microbiota composition measured from stool samples before and after the 12 week intervention.
Stool samples are collected before and after the intervention and stored frozen until analysis. Bacterial DNA is extracted from the samples and relevant bacterial groups including genus Bifidobacterium, species Bifidobacterium animalis subsp. lactis, Enterobacteriaceae, Escherichia coli, Bacteroidetes and Lactobacillus are measures with quantitative real-time PCR.
Measured: 12 weeks
Gut function questionaire as a measure of tolerability
Questionaire is used to assess the tolerability of the probiotic supplementation. Questionaire includes questions on frequency and severity of flatulence and bloating, occurence of diarhea, frequency of defecation, and texture of feces using a stool chart.
Measured: Symptoms during last 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2010
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic EndotoxemiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danisco
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01176942
- Sponsor's protocol ID
- PROMS-01
- Acronym
- PROMS-01
- Status last verified
- Dec 2014
- First submitted
- 24 May 2010
- Last updated
- 9 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics and Endotoxemia in Humans
- ClinicalTrials.gov ID
- NCT01176942
- Acronym / sponsor ID
- PROMS-01 / PROMS-01
- Conditions
- Metabolic Endotoxemia, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- DaniscoIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 6 Aug 2010 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: Probiotic bacterium Bifidobacterium lactis |
| Placebo | Placebo comparator | Dietary Supplement: Probiotic bacterium Bifidobacterium lactis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body mass index ≥ 27 kg/m2; above 18 years of age
- Used to eat high fat diet (more than 40% of total energy intake)
Key exclusion criteria (10 listed)
- Treated cardiovascular risk factors, treated hypertension, treated dyslipidemia, treated diabetes; Known diabetes, hypertension, dyslipidemia
- Severe illnesses
- Artificial heart valve
- Immunosuppression
- Regular consumption of probiotics
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 |
|---|---|---|
| Probiotic bacterium Bifidobacterium lactisAlso: Bifidobacterium animalis subsp. lactisProbiotic placebo controlled intervention | Dietary supplement | Placebo, Probiotic |
Primary outcome
Level of plasma endotoxin (plasma levels of lipopolysaccharides) in the volunteers before and after the 12 week intervention
Time frame: 12 weeks
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.
8 secondary outcomes
Volunteer weight before and after the 12 week intervention.
Time frame: 12 weeks
Volunteer waist perimeter before and after the 12 week intervention
Time frame: 12 weeks
Insulin resistance (HOMA-IR index), glycemia, insulinemia and glycated hemoglobin in the volunteers before and after the 12 week intervention
Time frame: 12 weeks
Brachial blood pressure of the volunteers before and after the 12 week intervention.
Time frame: 12 weeks
Blood lipids in the volunteers before and after the 12 week intervention.
Time frame: 12 weeks
Serum inflammatory markers of volunteers before and after the 12 week intervention.
Time frame: 12 weeks
Intestinal microbiota composition measured from stool samples before and after the 12 week intervention.
Time frame: 12 weeks
Gut function questionaire as a measure of tolerability
Time frame: Symptoms during last 6 days
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 9 Dec 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic bacterium Bifidobacterium lactis in people with Metabolic Endotoxemia and Metabolic Syndrome, run by Danisco at 1 site in France.
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 2 inclusion and 10 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 9 Dec 2014. 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 France. 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?
Level of plasma endotoxin (plasma levels of lipopolysaccharides) in the volunteers before and after the 12 week intervention (time frame: 12 weeks). 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 9 Dec 2014.