ObesityNCT01235026
Synbiotics and Low Grade Inflammation in Obese Subjects
A study testing Synbiotic in people with Obesity and Diabetes Mellitus Type-2, run by University of Chile at 1 site in Chile.
Trial summary
The purpose of this study is to determine whether the daily administration of a synbiotic (oligofructose and Bifidobacterium animalis subsp. lactis Bb12) for six weeks contributes to improve the glucose tolerance and the low grade inflammation (as reflected as the plasmatic concentrations of ultrasensitive CRP, IL-6… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Obesity, Diabetes Mellitus Type-2, Insulin Resistance
- What is being tested?
- Synbiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteChile
- Study dates
- Nov 2010to Jan 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI > 30
- Non-smokers
Who cannot join
- Current digestive diseases or antecedents of chronic digestive diseases and/or malabsorption (celiac disease, Inflammatory bowel diseases, gastroduodenal ulcers, digestive malignancies, etc)
- Use of drugs that could interfere with the intestinal microbiota or with the integrity of the gut barrier function (antibiotics, anti-inflammatory drugs, laxatives, prokinetics, etc.) during the three weeks preceding the start the study
- Treatments (medication or nutritional program) affecting body weight or glucose control
- Basal glycemia>130mg/dl (evaluated with glucose-meter)
- Immunodeficiencies (HIV, chemotherapy, radiotherapy, organ transplant).
- Current participation or recent previous having participation in another clinical trial.
Show all 9Show fewer
- Pregnant or breastfeeding women.
- Consumption of probiotic products
- Drug or alcohol abuse
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Institute of Nutrition and Food Technology (INTA), University of Chile
Santiago
Martin Gotteland, PhD
About this study
Official title: Impact of the Administration of a Synbiotic on Low Grade Inflammation in Obese Subjects
The purpose of this study is to determine whether the daily administration of a synbiotic (oligofructose and Bifidobacterium animalis subsp. lactis Bb12) for six weeks contributes to improve the glucose tolerance and the low grade inflammation (as reflected as the plasmatic concentrations of ultrasensitive CRP, IL-6, sCD14 and LPS-binding protein) in obese subjects.
Read the detailed description
Obesity is associated with a spectrum of metabolic disorders including high blood pressure, dyslipidemia, insulin resistance and a state of low grade inflammation that predispose individuals to the development of type-2 diabetes mellitus and cardiovascular diseases. The intestinal microbiota has been recently proposed as a new actor in the development of obesity and its complications. In animal models, high-fat diets have been shown to affect the intestinal microbiota, increasing colonic gram-negative bacteria and lipopolysaccharide (LPS) concentrations, resulting in an impaired gastrointestinal barrier function and in subsequent endotoxinemia in the animals. This phenomenon would trigger chronic inflammatory and metabolic disorders leading to insulin resistance and other complication such as hepatic steatosis. Probiotics and prebiotics are GRAS (Generally recognized as safe) food ingredients which have been proposed to maintain the balance of the intestinal microbiota. Studies in mice fed a high fat diet have shown that the administration of oligofructose increases the counts of Bifidobacterium spp. in the colon and correlatively induced decreases of the endotoxinemia and low-grade inflammation while at the same time improving insulin sensitivity.
On the basis of these antecedents, the aim of this study is to determine whether the intake of a synbiotic product (B. animalis subsp. lactis BB12+ Oligofructose) for six weeks contributes to improve the low grade inflammation and glucose tolerance of obese subjects.
Obese subjects will be randomized into two groups (Synbiotic or Placebo) stratifying by sex and age. Anthropometric data (body composition by Bod-pod, weight, height, waist circumference) and systolic and diastolic blood pressure will be registered. A food survey will be carried out by a trained dietitian to quantify fat consumption. Each subject of the Synbiotic group must ingest one gram of BB12 (containing 1010 CFU) and 5 g of oligofructose twice a day for 6 weeks while those from the Control group will receive the corresponding placebo (maltodextrin). Digestive symptoms as well as stool frequency and consistency will be registered daily during the study using ad hoc forms and the Bristol Chart.
Blood samples will be obtained at baseline, at the end of the six weeks period and one month after the end of the treatment, to determine lipid profiles and ultrasensitive C-reactive protein (CRP); plasmatic biomarkers of inflammation including IL-6, LPS binding protein and sCD14 will be also determined by Elisa using commercial kits. At the same times, a glycemia /insulinemia curve will be performed in the fasted subjects, as well as an intestinal permeability test (lactulose/mannitol/sucralose) to assess their gut barrier function. A fresh stool sample will be also obtained to characterize some bacterial population of their IM (Bifidobacterium, Lactobacillus, F. prausnitzii, Bacteroides and Clostridium cluster) by real-time PCR.
- Being tested
- Synbiotic, Placebo
- Keywords
- Obesity, Type-2 Diabetes, Metabolic syndrome, Low grade inflammation, Metabolic endotoxinemia, Insulin resistance, Lipopolysaccharide, LPS-binding protein, sCD14, Synbiotic, Oligofructose, Bifidobacterium animalis subsp. lactis Bb12, probiotic, Prebiotic
- Medical subject headings
- Obesity, Insulin Resistance, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SynbioticDietary supplement
5g of the prebiotic "Oligofructose" + 1 g of the probiotic "Bifidobacterium animalis subsp. lactis Bb12" (4x10^10 CFU/g), twice a day, for 6 weeks.
PlaceboDietary supplement
6g of maltodextrin, twice a day for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Synbiotic | Experimental | Dietary Supplement: Synbiotic: combination of the prebiotic "Oligofructose" with the probiotic "Bifidobacterium animalis subsp. lactis Bb12" Receives: Dietary Supplement: Synbiotic |
| Placebo | Placebo comparator | Dietary supplement: placebo: maltodextrin Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasmatic Interleukin-6 (IL-6)
Plasmatic IL-6 will be determined after 6 weeks of administration of the synbiotic and compared with the IL-6 values at baseline.
Measured: 6 weeks
Secondary outcomes (11)
Plasmatic LPS-binding protein
Plasmatic LPS-binding protein (LBP) will be determined after 6 weeks of administration of the synbiotic and compared with the LBP values at baseline.
Measured: 6 weeks
Plasmatic sCD14
Plasmatic sCD14 will be determined after 6 weeks of administration of the synbiotic and compared with the sCD14 values at baseline.
Measured: 6 weeks
glucose tolerance curve
Glucose tolerance will be determined after 6 weeks of administration of the synbiotic and compared with glucose tolerance at baseline.
Measured: 6 weeks
Lipid profile
Lipid profile will be determined after 6 weeks of administration of the synbiotic and compared with the lipid profile at baseline.
Measured: 6 weeks
plasmatic ultrasensitive C-Reactive Protein
Plasmatic ultrasensitive CRP will be determined after 6 weeks of administration of the synbiotic and compared with the usCRP values at baseline.
Measured: 6 weeks
Plasmatic IL-6
Plasmatic IL-6 will be determined after a 1-month washout period without synbiotic administration (week 10)and compared with the baseline and post-treatment (6 weeks) values.
Measured: 10 weeks
Plasmatic LBP
Plasmatic LBP will be determined after a 1-month washout period without synbiotic administration (week 10)and compared with the baseline and post-treatment (6 weeks) values.
Measured: 10 weeks
Plasmatic sCD14
Plasmatic sCD14 will be determined after a 1-month washout period without synbiotic administration (week 10)and compared with the baseline and post-treatment (6 weeks) values.
Measured: 10 weeks
Glucose tolerance curve
Glucose tolerance curves will be determined after a 1-month washout period without synbiotic administration (week 10)and compared with the baseline and post-treatment (6 weeks) values.
Measured: 10 weeks
Lipid profile
Lipid profile will be determined after a 1-month washout period without synbiotic administration (week 10)and compared with the baseline and post-treatment (6 weeks) values.
Measured: 10 weeks
Plasmatic usCRP
Plasmatic usCRP will be determined after a 1-month washout period without synbiotic administration (week 10)and compared with the baseline and post-treatment (6 weeks) values.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionDec 2010 (estimated)
- Study completionJan 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01235026
- Sponsor's protocol ID
- Fondecyt-1080519
- Status last verified
- Oct 2010
- First submitted
- 1 Nov 2010
- Last updated
- 17 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cani PD, Bibiloni R, Knauf C, Waget A, Neyrinck AM, Delzenne NM, Burcelin R. Changes in gut microbiota control metabolic endotoxemia-induced inflammation in high-fat diet-induced obesity and diabetes in mice. Diabetes. 2008 Jun;57(6):1470-81. doi: 10.2337/db07-1403. Epub 2008 Feb 27.
PubMed 18305141Cani PD, Neyrinck AM, Fava F, Knauf C, Burcelin RG, Tuohy KM, Gibson GR, Delzenne NM. Selective increases of bifidobacteria in gut microflora improve high-fat-diet-induced diabetes in mice through a mechanism associated with endotoxaemia. Diabetologia. 2007 Nov;50(11):2374-83. doi: 10.1007/s00125-007-0791-0. Epub 2007 Sep 6.
PubMed 17823788Ley RE, Turnbaugh PJ, Klein S, Gordon JI. Microbial ecology: human gut microbes associated with obesity. Nature. 2006 Dec 21;444(7122):1022-3. doi: 10.1038/4441022a.
PubMed 17183309Wright SD, Ramos RA, Tobias PS, Ulevitch RJ, Mathison JC. CD14, a receptor for complexes of lipopolysaccharide (LPS) and LPS binding protein. Science. 1990 Sep 21;249(4975):1431-3. doi: 10.1126/science.1698311.
PubMed 1698311Brunser O, Figueroa G, Gotteland M, Haschke-Becher E, Magliola C, Rochat F, Cruchet S, Palframan R, Gibson G, Chauffard F, Haschke F. Effects of probiotic or prebiotic supplemented milk formulas on fecal microbiota composition of infants. Asia Pac J Clin Nutr. 2006;15(3):368-76.
PubMed 16837430
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Administration of a Synbiotic on Low Grade Inflammation in Obese Subjects
- ClinicalTrials.gov ID
- NCT01235026
- Acronym / sponsor ID
- Fondecyt-1080519
- Keywords
- Obesity, Type-2 Diabetes, Metabolic syndrome, Low grade inflammation, Metabolic endotoxinemia, Insulin resistance, Lipopolysaccharide, LPS-binding protein
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Jan 2011 (estimated)
- First posted
- 5 Nov 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 the daily administration of a synbiotic (oligofructose and Bifidobacterium animalis subsp. lactis Bb12) for six weeks contributes to improve the glucose tolerance and the low grade inflammation (as reflected as the plasmatic concentrations of ultrasensitive CRP, IL-6, sCD14 and LPS-binding protein) in obese subjects.
Detailed description
Obesity is associated with a spectrum of metabolic disorders including high blood pressure, dyslipidemia, insulin resistance and a state of low grade inflammation that predispose individuals to the development of type-2 diabetes mellitus and cardiovascular diseases. The intestinal microbiota has been recently proposed as a new actor in the development of obesity and its complications. In animal models, high-fat diets have been shown to affect the intestinal microbiota, increasing colonic gram-negative bacteria and lipopolysaccharide (LPS) concentrations, resulting in an impaired gastrointestinal barrier function and in subsequent endotoxinemia in the animals. This phenomenon would trigger chronic inflammatory and metabolic disorders leading to insulin resistance and other complication such as hepatic steatosis. Probiotics and prebiotics are GRAS (Generally recognized as safe) food ingredients which have been proposed to maintain the balance of the intestinal microbiota. Studies in mice fed a high fat diet have shown that the administration of oligofructose increases the counts of Bifidobacterium spp. in the colon and correlatively induced decreases of the endotoxinemia and low-grade inflammation while at the same time improving insulin sensitivity.
On the basis of these antecedents, the aim of this study is to determine whether the intake of a synbiotic product (B. animalis subsp. lactis BB12+ Oligofructose) for six weeks contributes to improve the low grade inflammation and glucose tolerance of obese subjects.
Obese subjects will be randomized into two groups (Synbiotic or Placebo) stratifying by sex and age. Anthropometric data (body composition by Bod-pod, weight, height, waist circumference) and systolic and diastolic blood pressure will be registered. A food survey will be carried out by a trained dietitian to quantify fat consumption. Each subject of the Synbiotic group must ingest one gram of BB12 (containing 1010 CFU) and 5 g of oligofructose twice a day for 6 weeks while those from the Control group will receive the corresponding placebo (maltodextrin). Digestive symptoms as well as stool frequency and consistency will be registered daily during the study using ad hoc forms and the Bristol Chart.
Blood samples will be obtained at baseline, at the end of the six weeks period and one month after the end of the treatment, to determine lipid profiles and ultrasensitive C-reactive protein (CRP); plasmatic biomarkers of inflammation including IL-6, LPS binding protein and sCD14 will be also determined by Elisa using commercial kits. At the same times, a glycemia /insulinemia curve will be performed in the fasted subjects, as well as an intestinal permeability test (lactulose/mannitol/sucralose) to assess their gut barrier function. A fresh stool sample will be also obtained to characterize some bacterial population of their IM (Bifidobacterium, Lactobacillus, F. prausnitzii, Bacteroides and Clostridium cluster) by real-time PCR.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Synbiotic | Experimental | Dietary Supplement: SynbioticDietary Supplement: Synbiotic: combination of the prebiotic "Oligofructose" with the probiotic "Bifidobacterium animalis subsp. lactis Bb12" |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboDietary supplement: placebo: maltodextrin |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI > 30
- Non-smokers
Key exclusion criteria (9 listed)
- Current digestive diseases or antecedents of chronic digestive diseases and/or malabsorption (celiac disease, Inflammatory bowel diseases, gastroduodenal ulcers, digestive malignancies, etc)
- Use of drugs that could interfere with the intestinal microbiota or with the integrity of the gut barrier function (antibiotics, anti-inflammatory drugs, laxatives, prokinetics, etc.) during the three weeks preceding the start the study
- Treatments (medication or nutritional program) affecting body weight or glucose control
- Basal glycemia>130mg/dl (evaluated with glucose-meter)
- Immunodeficiencies (HIV, chemotherapy, radiotherapy, organ transplant).
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 |
|---|---|---|
| Synbiotic5g of the prebiotic "Oligofructose" + 1 g of the probiotic "Bifidobacterium animalis subsp. lactis Bb12" (4x10^10 CFU/g), twice a day, for 6 weeks. | Dietary supplement | Synbiotic |
| Placebo6g of maltodextrin, twice a day for 6 weeks. | Dietary supplement | Placebo |
Primary outcome
Plasmatic Interleukin-6 (IL-6)
Time frame: 6 weeks
Plasmatic IL-6 will be determined after 6 weeks of administration of the synbiotic and compared with the IL-6 values at baseline.
11 secondary outcomes
Plasmatic LPS-binding protein
Time frame: 6 weeks
Plasmatic sCD14
Time frame: 6 weeks
glucose tolerance curve
Time frame: 6 weeks
Lipid profile
Time frame: 6 weeks
plasmatic ultrasensitive C-Reactive Protein
Time frame: 6 weeks
Plasmatic IL-6
Time frame: 10 weeks
Plasmatic LBP
Time frame: 10 weeks
Plasmatic sCD14
Time frame: 10 weeks
Glucose tolerance curve
Time frame: 10 weeks
Lipid profile
Time frame: 10 weeks
Plasmatic usCRP
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2010.
- Background: PubMed 18305141Cani PD, Bibiloni R, Knauf C, Waget A, Neyrinck AM, Delzenne NM, Burcelin R. Changes in gut microbiota control metabolic endotoxemia-induced inflammation in high-fat diet-induced obesity and diabetes in mice. Diabetes. 2008 Jun;57(6):1470-81. doi: 10.2337/db07-1403. Epub 2008 Feb 27.
- Background: PubMed 17823788Cani PD, Neyrinck AM, Fava F, Knauf C, Burcelin RG, Tuohy KM, Gibson GR, Delzenne NM. Selective increases of bifidobacteria in gut microflora improve high-fat-diet-induced diabetes in mice through a mechanism associated with endotoxaemia. Diabetologia. 2007 Nov;50(11):2374-83. doi: 10.1007/s00125-007-0791-0. Epub 2007 Sep 6.
- Background: PubMed 17183309Ley RE, Turnbaugh PJ, Klein S, Gordon JI. Microbial ecology: human gut microbes associated with obesity. Nature. 2006 Dec 21;444(7122):1022-3. doi: 10.1038/4441022a.
- Background: PubMed 1698311Wright SD, Ramos RA, Tobias PS, Ulevitch RJ, Mathison JC. CD14, a receptor for complexes of lipopolysaccharide (LPS) and LPS binding protein. Science. 1990 Sep 21;249(4975):1431-3. doi: 10.1126/science.1698311.
- Background: PubMed 16837430Brunser O, Figueroa G, Gotteland M, Haschke-Becher E, Magliola C, Rochat F, Cruchet S, Palframan R, Gibson G, Chauffard F, Haschke F. Effects of probiotic or prebiotic supplemented milk formulas on fecal microbiota composition of infants. Asia Pac J Clin Nutr. 2006;15(3):368-76.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synbiotic in people with Obesity and Diabetes Mellitus Type-2, run by University of Chile at 1 site in Chile.
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 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: status not confirmed, as of the sponsor's last update on 17 Dec 2010. 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 Chile. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martin Gotteland, PhD (56-2-9781471, mgottela@inta.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasmatic Interleukin-6 (IL-6) (time frame: 6 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 NCT01235026, which also lists 5 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 17 Dec 2010.