DiabetesDiabesityNCT02469558
Probiotics in Diabesity: A Pilot Study
A study testing Winclove 851 and 110 in people with Diabetes and Obesity, run by Medical University of Graz at 1 site in Austria.
Trial summary
Obesity and type 2 diabetes are a pandemic disease leading to a high morbidity and mortality. Probiotic modulation of gut flora is a possible therapeutic mechanism. The aim of this study is to investigate and compare thoroughly the effect of a multispecies probiotic on glycaemic control, gut microbiota and gut… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- What is being tested?
- Winclove 851 and 110
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteAustria
- Study dates
- Sep 2015to 31 Dec 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
- Age above 18 years
- Type 2 diabetes
- BMI 30-40 kg/m²
- HbA1c ≥ 6.5% (48 mmol/mol)
- Stable diabetes therapy over 6 months
- Person commits to the need for long-term follow-up
Who cannot join
- Type 1 diabetes mellitus
- Maturity Onset Diabetes of the Young (MODY)
- Secondary diabetes due to a specific disease or glucocorticoid therapy
- Pregnancy
- Hypothalamic cause of obesity, Cushing syndrome
- Major psychiatric diseases including diagnosed eating disorders, history of drug or alcohol abuse
Show all 16Show fewer
- History of bariatric surgery
- Use of probiotics (other than the study product)
- Antibiotic therapy within the last 4 weeks before inclusion
- Inflammatory bowel disease
- Pancreatitis
- Chronic non-steroidal anti-inflammatory drug (NSAID) treatment
- glucagon-like peptide-1 receptor agonist therapy or acarbose therapy
- Recent (less than 12 weeks) acute myocardial infarction or decompensated heart failure
- Recent (less than 12 weeks) stroke
- Known malignancy or any other condition or circumstance, which, in the opinion of the investigator, would affect the patient's ability to participate in the protocol
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Graz, Department of Internal Medicine
Graz, 8036
About this study
Obesity and type 2 diabetes are a pandemic disease leading to a high morbidity and mortality. Probiotic modulation of gut flora is a possible therapeutic mechanism.
The aim of this study is to investigate and compare thoroughly the effect of a multispecies probiotic on glycaemic control, gut microbiota and gut permeability in patients with metabolic syndrome and diabetes.
Read the detailed description
Obesity and diabetes probably represent the most challenging threat to public health in the 21st century. The World Health Organization (WHO) predicts that by 2015 approximately 2.3 billion adults will be overweight (BMI 25-29.9 kg/m²), and more than 700 million will be obese (BMI 30 kg/m² or more). In addition, currently 285 million people worldwide suffer from type 2 diabetes (T2DM), and this number is predicted to increase to 439 million by 2030. T2DM raises the risk for cardiovascular morbidity and mortality, as well as eye problems, nerve damage and kidney diseases. Previous studies demonstrated that the impact of diabetes on everyday life and the likelihood of costly and disabling complications can be reduced by more intensive management of glucose, blood pressure and cholesterol. Weight reduction is the most desired but also most difficult to achieve treatment option in obesity, that is able to prevent secondary complications of obesity and T2DM.
Since weight reduction by diet and increased physical activity alone is difficult to achieve in morbidly obese subjects, other, more aggressive approaches, such as bariatric surgery have been invented.
Recent preclinical and clinical studies have indicated an important influence of the intestinal microbiome (gut metagenome) on obesity and associated metabolic disorders (metabolic syndrome, type 2 diabetes, metabolic liver diseases, cardiovascular diseases). For instance, the cecum microbiota of rodents was found to be significantly different in obese than in lean mice. This finding of altered gut microbiota was then confirmed and extended to humans. Additionally, these investigations in humans demonstrated that as obese people lose weight, the composition of microflora shifted, and more closely resembled that of the lean individuals. This suggests that the microflora might be involved in the pathogenesis of obesity, insulin resistance and T2DM by having an impact on gut permeability and chronic inflammation. Probiotic, prebiotic or synbiotic interventions have been shown to be effective in modulating gut permeability and gut microbiota in animals and thereby modulating chronic inflammation and metabolic disorders in animal models. In humans this has not been shown unequivocally so far.
However, it is yet unknown, who will benefit from which intervention and why individuals respond differently to these interventions.
The aim of this study is to investigate and compare thoroughly the effect of a multispecies probiotic on glycaemic control, gut microbiota and gut permeability in patients with metabolic syndrome and diabetes. The investigators aim to access changes in insulin sensitivity, islet function and the secretion of gut hormones. In addition, the investigators will investigate changes in gut microbiota and gut permeability to understand the underlying mechanism. After investigating the mechanism the overarching aim is to identify biomarkers, which would allow better prediction of treatment success. In future this would allow tailoring obesity and diabetes treatment in order to give every patient the optimal treatment at lowest costs.
- Being tested
- Winclove 851 and 110, Placebo
- Medical subject headings
- Diabetes Mellitus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Winclove 851 and 110Dietary supplement
prebiotic and probiotic mixture
PlaceboDietary supplement
white powder without pro/probiotic
| Study group | Role | What they receive |
|---|---|---|
| probiotic | Active comparator | Winclove 851 and 110 consist of 6g of a probiotic mixture containing Bifidobacterium bifidum W23, Bifidobacterium lactis W52, Bifidobacterium lactis W51, Lactobacillus acidophilus W37, Lactobacillus brevis W63, Lactobacillus casei W56, Lactobacillus salivarius W24, Lactococcus lactis W19, Lactococcus lactis W58 at a concentration of 2.5 x 109 cfu/g and 10g of a prebiotic mixture of galacto-oligosaccharides P11 (GOS), Fructo-oligosaccharides P6 (FOS), Konjac glucomannan P13 (E425), Maltodextrin, Calcium carbonate (E170), Natural Elderflower flavouring, Gum Arabic (E414), Zinc citrate 3-hydrate, Vitamin D3 (Cholecalciferol) and Vitamin B2 (Riboflavin) (E101) daily for 6 months Receives: Dietary Supplement: Winclove 851 and 110 |
| placebo | Placebo comparator | a similar looking and tasting placebo without bacteria Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
insulin sensitivity
meal tolerance test
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2015 (estimated)
- Study startSep 2015
- Primary completion31 Dec 2018
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vanessa Stadlbauer-Köllner, MD, Principal investigator, Medical University of GrazHarald Sourij, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02469558
- Sponsor's protocol ID
- 26-464 ex 13/14
- Acronym
- Diabesity
- Status last verified
- Feb 2020
- First submitted
- 3 Jun 2015
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics in Diabesity: A Pilot Study
- ClinicalTrials.gov ID
- NCT02469558
- Acronym / sponsor ID
- Diabesity / 26-464 ex 13/14
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 11 Jun 2015 (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.
Obesity and type 2 diabetes are a pandemic disease leading to a high morbidity and mortality. Probiotic modulation of gut flora is a possible therapeutic mechanism.
The aim of this study is to investigate and compare thoroughly the effect of a multispecies probiotic on glycaemic control, gut microbiota and gut permeability in patients with metabolic syndrome and diabetes.
Detailed description
Obesity and diabetes probably represent the most challenging threat to public health in the 21st century. The World Health Organization (WHO) predicts that by 2015 approximately 2.3 billion adults will be overweight (BMI 25-29.9 kg/m²), and more than 700 million will be obese (BMI 30 kg/m² or more). In addition, currently 285 million people worldwide suffer from type 2 diabetes (T2DM), and this number is predicted to increase to 439 million by 2030. T2DM raises the risk for cardiovascular morbidity and mortality, as well as eye problems, nerve damage and kidney diseases. Previous studies demonstrated that the impact of diabetes on everyday life and the likelihood of costly and disabling complications can be reduced by more intensive management of glucose, blood pressure and cholesterol. Weight reduction is the most desired but also most difficult to achieve treatment option in obesity, that is able to prevent secondary complications of obesity and T2DM.
Since weight reduction by diet and increased physical activity alone is difficult to achieve in morbidly obese subjects, other, more aggressive approaches, such as bariatric surgery have been invented.
Recent preclinical and clinical studies have indicated an important influence of the intestinal microbiome (gut metagenome) on obesity and associated metabolic disorders (metabolic syndrome, type 2 diabetes, metabolic liver diseases, cardiovascular diseases). For instance, the cecum microbiota of rodents was found to be significantly different in obese than in lean mice. This finding of altered gut microbiota was then confirmed and extended to humans. Additionally, these investigations in humans demonstrated that as obese people lose weight, the composition of microflora shifted, and more closely resembled that of the lean individuals. This suggests that the microflora might be involved in the pathogenesis of obesity, insulin resistance and T2DM by having an impact on gut permeability and chronic inflammation. Probiotic, prebiotic or synbiotic interventions have been shown to be effective in modulating gut permeability and gut microbiota in animals and thereby modulating chronic inflammation and metabolic disorders in animal models. In humans this has not been shown unequivocally so far.
However, it is yet unknown, who will benefit from which intervention and why individuals respond differently to these interventions.
The aim of this study is to investigate and compare thoroughly the effect of a multispecies probiotic on glycaemic control, gut microbiota and gut permeability in patients with metabolic syndrome and diabetes. The investigators aim to access changes in insulin sensitivity, islet function and the secretion of gut hormones. In addition, the investigators will investigate changes in gut microbiota and gut permeability to understand the underlying mechanism. After investigating the mechanism the overarching aim is to identify biomarkers, which would allow better prediction of treatment success. In future this would allow tailoring obesity and diabetes treatment in order to give every patient the optimal treatment at lowest costs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| probiotic | Active comparator | Dietary Supplement: Winclove 851 and 110Winclove 851 and 110 consist of 6g of a probiotic mixture containing Bifidobacterium bifidum W23, Bifidobacterium lactis W52, Bifidobacterium lactis W51, Lactobacillus acidophilus W37, Lactobacillus brevis W63, Lactobacillus casei W56, Lactobacillus salivarius W24, Lactococcus lactis W19, Lactococcus lactis W58 at a concentration of 2.5 x 109 cfu/g and 10g of a prebiotic mixture of galacto-oligosaccharides P11 (GOS), Fructo-oligosaccharides P6 (FOS), Konjac glucomannan P13 (E425), Maltodextrin, Calcium carbonate (E170), Natural Elderflower flavouring, Gum Arabic (E414), Zinc citrate 3-hydrate, Vitamin D3 (Cholecalciferol) and Vitamin B2 (Riboflavin) (E101) daily for 6 months |
| placebo | Placebo comparator | Dietary Supplement: Placeboa similar looking and tasting placebo without bacteria |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Age above 18 years
- Type 2 diabetes
- BMI 30-40 kg/m²
- HbA1c ≥ 6.5% (48 mmol/mol)
Key exclusion criteria (16 listed)
- Type 1 diabetes mellitus
- Maturity Onset Diabetes of the Young (MODY)
- Secondary diabetes due to a specific disease or glucocorticoid therapy
- Pregnancy
- Hypothalamic cause of obesity, Cushing syndrome
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 |
|---|---|---|
| Winclove 851 and 110prebiotic and probiotic mixture | Dietary supplement | probiotic |
| Placebowhite powder without pro/probiotic | Dietary supplement | placebo |
Primary outcome
insulin sensitivity
Time frame: 12 months
meal tolerance test
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 6 Feb 2020.
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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.
Vanessa Stadlbauer-Köllner, MD principal investigator
Medical University of Graz
Harald Sourij, MD principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Winclove 851 and 110 in people with Diabetes and Obesity, run by Medical University of Graz at 1 site in Austria.
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 7 inclusion and 16 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 6 Feb 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 Austria. 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?
insulin sensitivity (time frame: 12 months). 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 6 Feb 2020.