Metabolic Syndrome XPROSIRNCT02972567
Evaluation of the Effects of a L.Reuteri Strain on Markers of Inflammation, Cardiovascular Risk and Fatty Liver Disease
A study testing Lactobacillus spp in people with Metabolic Syndrome X, run by Biosearch S.A. at 1 site in Spain.
Trial summary
The purpose of this study is the evaluation of the effects in obese patients with metabolic syndrome on the composition of the intestinal microbiota, markers of the syndrome (hypertension, dyslipidemia, inflammation biomarkers, risk cardiovascular and hepatic steatosis) and other possible metabolites involved. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Metabolic Syndrome X
- What is being tested?
- Lactobacillus spp
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- May 2016to Dec 2017
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis of insulin resistance syndrome, according to Criteria of the International Diabetes Federation (IDF)
- BMI>30 kg/m2 or Waist Circumference ≥ 94cm (men) WC≥ 80cm (women)
- Serum Triglycerides ≥ 150 mg/dl
- HDLcholesterol < 40 mg/dl (1,03 mmol/l) in men and < 50 mg/dl (1,29 mmol/l) in women
- Systolic blood pressure ≥ 130 mmHg or diastolic ≥ 85 mmHg
- Glucose ≥ 100 mg/dl (5,6 mmol/l) (not previous diagnostic of diabetes II)
Who cannot join
- Patients with renal or hepatic impairment
- Patients with a diagnosis of diabetes
- Patients with diseases that condition immunosuppression
- Patients presenting positive serologies for liver viruses
- Being on antihypertensive treatment: beta-blockers, Angiotensin 2 receptor antagonists (ARA 2), enzyme inhibitors, Angiotensin converting enzyme (ACE) inhibitors.
- Patients receiving lipid-lowering and / or hypoglycemic agents
Show all 9Show fewer
- Patients on treatment with drugs that increase hepatic enzymes,such as Amiodarone, perhexiline, maleate and 4,4'-diethylaminoethoxyhexestrol, synthetic estrogens, Tamoxifen, corticosteroids, acetylsalicylic acid, Valproic acid, tetracyclines, viral agents (zidovudine, zalcitabine, didanosine), among others.
- Exhibiting high values of C-reactive protein (CRP) or Sedimentation (ESR)
- Consuming alcohol in quantities greater than 40 g / d or other hepatotoxic.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of a Lactobacillus Reuteri Strain on Markers of Inflammation, Cardiovascular Risk and Fatty Liver Disease in Obese Subjects With Insulin Resistance
The purpose of this study is the evaluation of the effects in obese patients with metabolic syndrome on the composition of the intestinal microbiota, markers of the syndrome (hypertension, dyslipidemia, inflammation biomarkers, risk cardiovascular and hepatic steatosis) and other possible metabolites involved.
Read the detailed description
Randomized double blind crossover placebo controlled intervention study
The proposed study will be conducted by members of the Endocrinology and Nutrition Services (ENCHJ), and Gastroenterology (ADCHJ), of the Hospital of Jaen and members of the Department of Biochemistry and Molecular Biology II of the University of Granada (UGR) and members of Microbiology Department of the University Hospital San Cecilio of Granada (MHUSC).
The selection, clinical and anthropometric control, general biochemical parameters and the determination of hepatic steatosis by ultrasound will be performed by members of ENCHJ.
The determination of the composition of the intestinal microbiota will be carried out by members of the UGR together with members form the MHUSC. Inflammation and steatosis biomarkers as well as metabolic profile will be performed by members of the UGR.
The study will be conducted according to the Helsinki Rules and will be previously approved by the Ethics Committee of Research of Jaen. The study will follow the rules of international, national and regional research The biological samples will be managed and processed in accordance with the research protocols by the Biobanco del Sistema Sanitario Público de Andalucía. At the end of the project, samples will be stored within the framework of Biobank from Public Health Organization of Andalusia .
The present study involves access and use of information confidential, so all the data will be treated anonymously.
- Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect.
Based on the range and median value on plasma lipopolysaccharide (LPS), and assuming a power of 90% and a type error alpha of 5%, the minimum number of subjects was 32. To avoid possible bias caused by gender and taking into account the withdrawal, will be recruited 60 subjects.
The missing data will be considered as unavailable data.
All statistical analyses will be performed using the statistical package SPSS (Statistical Product and Service Solutions). Normally distributed data will be expressed as the mean and standard error of the mean, whereas median and ranges will be used for data not normally distributed.
- Conditions
- Metabolic Syndrome X
- Being tested
- Lactobacillus spp, Control
- Keywords
- probiotics, metabolic syndrome, non-alcoholic fatty liver disease
- Medical subject headings
- Metabolic Syndrome, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus sppDietary supplement
9 log10 cfu/capsule. 1 capsule/day for 12 weeks
ControlDietary supplement
Maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Lactobacillus strain Receives: Dietary Supplement: Lactobacillus spp |
| Control | Placebo comparator | Maltodextrin Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from basal plasma lipopolysaccharide (LPS) at 12 weeks
Measured: Basal (T0), 12 weeks
Secondary outcomes (6)
Change from basal Blood pressure at 12 weeks
Measured: Basal (T0), 12 weeks
Change from basal HOMA ( homeostatic model assessment ) index at 12 weeks
Measured: Basal (T0), 12 weeks
Change from basal plasma cholesterol level (total, LDL and HDL) at 12 weeks
Measured: Basal (T0), 12 weeks
Change from basal plasma Inflammatory markers (sVCAM, sICAM, myeloperoxidase selectin, adiponectin, plasminogen activator inhibitor and resistin, and interleukines Il-6, Il-8, tumor necrosis factor, HGF, leptin and Multicopper oxidase-1) at 12 weeks
Measured: Basal (T0), 12 weeks
Change from basal Hepatic Steatosis markers (arginase, prolidase and RBP-4(Retinol binding protein-4)) at 12 weeks
Measured: Basal (T0), 12 weeks
Changes from basal fecal microbiota at 12 weeks
Measured: Basal (T0), 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Metabolic Syndrome XStudies 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosearch S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universidad de Granada, Complejo Hospitalario de Jaen
- Responsible party
- Sponsor
- Investigators
- Gil Ángel, Prof. Ph.D, Study director, University of Granada (Spain)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02972567
- Sponsor's protocol ID
- P3600
- Acronym
- PROSIR
- Status last verified
- Jul 2020
- First submitted
- 17 Nov 2016
- Last updated
- 13 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Turnbaugh PJ, Ley RE, Mahowald MA, Magrini V, Mardis ER, Gordon JI. An obesity-associated gut microbiome with increased capacity for energy harvest. Nature. 2006 Dec 21;444(7122):1027-31. doi: 10.1038/nature05414.
PubMed 17183312Backhed F, Manchester JK, Semenkovich CF, Gordon JI. Mechanisms underlying the resistance to diet-induced obesity in germ-free mice. Proc Natl Acad Sci U S A. 2007 Jan 16;104(3):979-84. doi: 10.1073/pnas.0605374104. Epub 2007 Jan 8.
PubMed 17210919Bermudez-Brito M, Munoz-Quezada S, Gomez-Llorente C, Matencio E, Bernal MJ, Romero F, Gil A. Human intestinal dendritic cells decrease cytokine release against Salmonella infection in the presence of Lactobacillus paracasei upon TLR activation. PLoS One. 2012;7(8):e43197. doi: 10.1371/journal.pone.0043197. Epub 2012 Aug 14.
PubMed 22905233Tenorio-Jimenez C, Martinez-Ramirez MJ, Tercero-Lozano M, Arraiza-Irigoyen C, Del Castillo-Codes I, Olza J, Plaza-Diaz J, Fontana L, Migueles JH, Olivares M, Gil A, Gomez-Llorente C. Evaluation of the effect of Lactobacillus reuteri V3401 on biomarkers of inflammation, cardiovascular risk and liver steatosis in obese adults with metabolic syndrome: a randomized clinical trial (PROSIR). BMC Complement Altern Med. 2018 Nov 20;18(1):306. doi: 10.1186/s12906-018-2371-x.
PubMed 30453950
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of a Lactobacillus Reuteri Strain on Markers of Inflammation, Cardiovascular Risk and Fatty Liver Disease in Obese Subjects With Insulin Resistance
- ClinicalTrials.gov ID
- NCT02972567
- Acronym / sponsor ID
- PROSIR / P3600
- Conditions
- Metabolic Syndrome X
- Keywords
- probiotics, metabolic syndrome, non-alcoholic fatty liver disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Biosearch S.A.Industry (pharma, biotech, devices)
- Collaborators
- Universidad de Granada, Complejo Hospitalario de Jaen
- Study start
- May 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 23 Nov 2016 (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 the evaluation of the effects in obese patients with metabolic syndrome on the composition of the intestinal microbiota, markers of the syndrome (hypertension, dyslipidemia, inflammation biomarkers, risk cardiovascular and hepatic steatosis) and other possible metabolites involved.
Detailed description
Randomized double blind crossover placebo controlled intervention study
The proposed study will be conducted by members of the Endocrinology and Nutrition Services (ENCHJ), and Gastroenterology (ADCHJ), of the Hospital of Jaen and members of the Department of Biochemistry and Molecular Biology II of the University of Granada (UGR) and members of Microbiology Department of the University Hospital San Cecilio of Granada (MHUSC).
The selection, clinical and anthropometric control, general biochemical parameters and the determination of hepatic steatosis by ultrasound will be performed by members of ENCHJ.
The determination of the composition of the intestinal microbiota will be carried out by members of the UGR together with members form the MHUSC. Inflammation and steatosis biomarkers as well as metabolic profile will be performed by members of the UGR.
The study will be conducted according to the Helsinki Rules and will be previously approved by the Ethics Committee of Research of Jaen. The study will follow the rules of international, national and regional research The biological samples will be managed and processed in accordance with the research protocols by the Biobanco del Sistema Sanitario Público de Andalucía. At the end of the project, samples will be stored within the framework of Biobank from Public Health Organization of Andalusia .
The present study involves access and use of information confidential, so all the data will be treated anonymously.
- Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect.
Based on the range and median value on plasma lipopolysaccharide (LPS), and assuming a power of 90% and a type error alpha of 5%, the minimum number of subjects was 32. To avoid possible bias caused by gender and taking into account the withdrawal, will be recruited 60 subjects.
The missing data will be considered as unavailable data.
All statistical analyses will be performed using the statistical package SPSS (Statistical Product and Service Solutions). Normally distributed data will be expressed as the mean and standard error of the mean, whereas median and ranges will be used for data not normally distributed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: Lactobacillus sppLactobacillus strain |
| Control | Placebo comparator | Dietary Supplement: ControlMaltodextrin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with a diagnosis of insulin resistance syndrome, according to Criteria of the International Diabetes Federation (IDF)
- BMI>30 kg/m2 or Waist Circumference ≥ 94cm (men) WC≥ 80cm (women)
- Serum Triglycerides ≥ 150 mg/dl
- HDLcholesterol < 40 mg/dl (1,03 mmol/l) in men and < 50 mg/dl (1,29 mmol/l) in women
- Systolic blood pressure ≥ 130 mmHg or diastolic ≥ 85 mmHg
Key exclusion criteria (9 listed)
- Patients with renal or hepatic impairment
- Patients with a diagnosis of diabetes
- Patients with diseases that condition immunosuppression
- Patients presenting positive serologies for liver viruses
- Being on antihypertensive treatment: beta-blockers, Angiotensin 2 receptor antagonists (ARA 2), enzyme inhibitors, Angiotensin converting enzyme (ACE) inhibitors.
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 |
|---|---|---|
| Lactobacillus spp9 log10 cfu/capsule. 1 capsule/day for 12 weeks | Dietary supplement | Probiotic |
| ControlMaltodextrin | Dietary supplement | Control |
Primary outcome
Change from basal plasma lipopolysaccharide (LPS) at 12 weeks
Time frame: Basal (T0), 12 weeks
6 secondary outcomes
Change from basal Blood pressure at 12 weeks
Time frame: Basal (T0), 12 weeks
Change from basal HOMA ( homeostatic model assessment ) index at 12 weeks
Time frame: Basal (T0), 12 weeks
Change from basal plasma cholesterol level (total, LDL and HDL) at 12 weeks
Time frame: Basal (T0), 12 weeks
Change from basal plasma Inflammatory markers (sVCAM, sICAM, myeloperoxidase selectin, adiponectin, plasminogen activator inhibitor and resistin, and interleukines Il-6, Il-8, tumor necrosis factor, HGF, leptin and Multicopper oxidase-1) at 12 weeks
Time frame: Basal (T0), 12 weeks
Change from basal Hepatic Steatosis markers (arginase, prolidase and RBP-4(Retinol binding protein-4)) at 12 weeks
Time frame: Basal (T0), 12 weeks
Changes from basal fecal microbiota at 12 weeks
Time frame: Basal (T0), 12 weeks
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 13 Jul 2020.
- Results publication: PubMed 17183312Turnbaugh PJ, Ley RE, Mahowald MA, Magrini V, Mardis ER, Gordon JI. An obesity-associated gut microbiome with increased capacity for energy harvest. Nature. 2006 Dec 21;444(7122):1027-31. doi: 10.1038/nature05414.
- Results publication: PubMed 17210919Backhed F, Manchester JK, Semenkovich CF, Gordon JI. Mechanisms underlying the resistance to diet-induced obesity in germ-free mice. Proc Natl Acad Sci U S A. 2007 Jan 16;104(3):979-84. doi: 10.1073/pnas.0605374104. Epub 2007 Jan 8.
- Results publication: PubMed 22905233Bermudez-Brito M, Munoz-Quezada S, Gomez-Llorente C, Matencio E, Bernal MJ, Romero F, Gil A. Human intestinal dendritic cells decrease cytokine release against Salmonella infection in the presence of Lactobacillus paracasei upon TLR activation. PLoS One. 2012;7(8):e43197. doi: 10.1371/journal.pone.0043197. Epub 2012 Aug 14.
- Derived from this study: PubMed 30453950Tenorio-Jimenez C, Martinez-Ramirez MJ, Tercero-Lozano M, Arraiza-Irigoyen C, Del Castillo-Codes I, Olza J, Plaza-Diaz J, Fontana L, Migueles JH, Olivares M, Gil A, Gomez-Llorente C. Evaluation of the effect of Lactobacillus reuteri V3401 on biomarkers of inflammation, cardiovascular risk and liver steatosis in obese adults with metabolic syndrome: a randomized clinical trial (PROSIR). BMC Complement Altern Med. 2018 Nov 20;18(1):306. doi: 10.1186/s12906-018-2371-x.
- Individual participant dataSharing planned: No
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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.
Gil Ángel, Prof. Ph.D study director
University of Granada (Spain)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus spp in people with Metabolic Syndrome X, run by Biosearch S.A. at 1 site in Spain.
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 6 inclusion and 9 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 13 Jul 2020. 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 Spain. 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?
Change from basal plasma lipopolysaccharide (LPS) at 12 weeks (time frame: Basal (T0), 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02972567, which also lists 4 linked publications.
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 13 Jul 2020.