Metabolic Syndrome xMicrobes4UNCT02637115
Evaluation of the Effects Associated With the Administration of Akkermansia Muciniphila on Parameters of Metabolic Syndrome
A study testing Live Akk 9, Live Akk 10 and Killed Akk in people with Metabolic Syndrome x and Glucose Metabolism Disorders, run by Patrice D. Cani at 1 site in Belgium.
Trial summary
Overweight and obesity have reached worldwide epidemic level. Both overweight and obesity are characterized by comorbidities such as cardio-metabolic risk factors (i.e., insulin resistance, type 2 diabetes, hypertension, dyslipidemia, low-grade inflammation) representing a major public health problem. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Metabolic Syndrome x, Glucose Metabolism Disorders, Dyslipidemias
- What is being tested?
- Live Akk 9, Live Akk 10 and Killed Akk
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2015to 20 Feb 2018
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 70 years old
- Caucasian
- Insulin resistance (based on HOMA single-value)
- BMI between 25 and 50 kg/m²
- Metabolic syndrome: presence of at least 3 of the following criteria
- Hypertension (blood pressure ≥ 130/85 mm Hg or antihypertensive treatment)
Show all 11Show fewer
- Hypertriglyceridemia (triglyceridemia ≥ 150mg/dl)
- Low HDL-cholesterol (HDL-cholesterol < 40mg/dl for males, 50mg/dl for females)
- Visceral obesity (waist circumference > 102 cm for males, 88cm for females)
- Fasting hyperglycemia (fasting glycemia ≥ 110mg/dl)
- Informed consent signed by the patient
Who cannot join
- Acute or chronic progressive or chronic unstabilized diseases
- Alcohol consumption (more than 2 glasses per day)
- Previous bariatric surgery
- Surgery in the 3 months prior the study or surgery planned in the next 6 months
- Pregnancy or pregnancy planned in the next 6 months
- More than 30 minutes of sports 3 times per week
Show all 15Show fewer
- Consumption of dietary supplement (omega-3 fatty acids, probiotics, prebiotics, plant stanols/sterols) in the month prior the study
- Inflammatory bowel disease or irritable bowel syndrome
- Diabetic gastrointestinal autonomic neuropathy (such as gastroparesis or reduced gastrointestinal motility)
- Consumption of more than 30g of dietary fibers per day
- Vegetarian or unusual diet
- Lactose intolerance or milk protein allergy
- Gluten intolerance
- Medications influencing parameters of interest (antidiabetic drugs such as metformin, DPP-4 inhibitors, GLP-1 receptor agonists, acarbose, hypoglycemic sulfonamides,glinides, thiazolidinediones, SGLT2 inhibitors, insulin,lactulose, consumption of antibiotics in the 2 months prior the study, corticosteroids, immunosuppressive agents, statins, fibrate, orlistat, cholestyramine, ezetimibe)
- Glycated hemoglobin (HbA1c) > 7.5%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effects Associated With the Administration of Akkermansia Muciniphila on Parameters of Metabolic Syndrome Related to Obesity
Overweight and obesity have reached worldwide epidemic level. Both overweight and obesity are characterized by comorbidities such as cardio-metabolic risk factors (i.e., insulin resistance, type 2 diabetes, hypertension, dyslipidemia, low-grade inflammation) representing a major public health problem. Therefore, it is urgent to find a therapeutic solution to target all these metabolic disorders. Among the environmental factors able to influence the individual susceptibility to gain weight and to develop metabolic disorders associated with obesity, more and more evidence show that the trillions of bacteria housed in our gastro-intestinal tract (i.e, gut microbiota) influence host metabolism. The investigators recently discovered a putative interesting microbial candidate, namely Akkermansia muciniphila (Akk). More exactly, we found that the administration of Akkermansia muciniphila reduced body weight gain, fat mass gain, glycemia and inflammatory markers in diet-induced obese mice. Moreover, in overweight/obese patients with cardiovascular risk factors subjected to a calorie restriction diet (calorie restriction diet for 6 weeks and an additional 6 weeks of weight maintenance), a higher abundance of Akkermansia muciniphila was associated with a better cardio-metabolic status in these patients. The investigators also discovered that patients having more Akkermansia muciniphila in their gut before the calorie restriction exhibited a greater improvement in glucose homoeostasis, blood lipids and body composition after calorie restriction. These observations suggested that the administration of Akkermansia muciniphila in overweight or obese people could be a very interesting therapeutic solution. Currently, no human study has investigated the beneficial effects of Akkermansia muciniphila administration on obesity and metabolic disorders. The overall objective of this study is to evaluate the effects associated with the administration of live or heat-killed Akkermansia muciniphila on the metabolic disorders (insulin-resistance, type-2 diabetes, dyslipidemia, inflammation) related to overweight and obesity in humans.
- Being tested
- Placebo, Live Akk 9, Live Akk 10, Killed Akk
- Keywords
- Gut microbiota, Akkermansia muciniphila
- Medical subject headings
- Metabolic Syndrome, Glucose Metabolism Disorders, Dyslipidemias, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Consumption of one dose-sachet per day. This dose-sachet contains a placebo (PBS/Glycerol)
Live Akk 9Dietary supplement
Consumption of one dose-sachet per day. This dose-sachet contains Live Akkermansia muciniphila (one billion per dose-sachet)
Live Akk 10Dietary supplement
Consumption of one dose-sachet per day. This dose-sachet contains Live Akkermansia muciniphila (ten billion per dose-sachet)
Killed AkkDietary supplement
Consumption of one dose-sachet per day. This dose-sachet contains heat-killed Akkermansia muciniphila
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo corresponds to a solution of Phosphate buffer saline (PBS) and glycerol, that is the carrier used in the 3 other groups receiving the bacteria (active arms) Receives: Dietary Supplement: Placebo |
| Live Akk 9 | Experimental | Live Akkermansia muciniphila (Akk) at the dose of 10exp9 live bacteria (one billion of live bacteria) per day Receives: Dietary Supplement: Live Akk 9 |
| Live Akk 10 | Experimental | Live Akkermansia muciniphila (Akk) at the dose of 10exp10 live bacteria (ten billion of live bacteria) per day Receives: Dietary Supplement: Live Akk 10 |
| Killed Akk | Experimental | This group corresponds to Akkermansia muciniphila that have been heat-killed. The initial quantity of bacteria before the heating procedure was of 10exp10 bacteria. Receives: Dietary Supplement: Killed Akk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance
self reporting of gastrointestinal symptoms (nausea, bloating, flatulence, cramp, borborygmi and gastric reflux)
Measured: 15 days
Tolerance
self reporting of gastrointestinal symptoms (nausea, bloating, flatulence, cramp, borborygmi and gastric reflux)
Measured: 3 months
Concentration of urea (mg/dl)
measure of urea as marker of renal function
Measured: 15 days
Concentration of urea (mg/dl)
measure of urea as marker of renal function
Measured: 3 months
Glomerular filtration rate (mL/min/1.73m2)
measure of glomerular filtration rate as marker of renal function
Measured: 15 days
Glomerular filtration rate (mL/min/1.73m2)
measure of glomerular filtration rate as marker of renal function
Measured: 3 months
Concentration of creatinine (mg/dl)
measure of creatinine as marker of renal function
Measured: 15 days
Concentration of creatinine (mg/dl)
measure of creatinine as marker of renal function
Measured: 3 months
Concentration of liver transaminases
measure of alanine aminotransferase (U/L); aspartate aminotransferase (U/L); gamma glutamyl transpeptidase (U/L). Lactate dehydrogenase (UI/L) as markers of hepatic inflammation
Measured: 15 days
Concentration of liver transaminases
measure of alanine aminotransferase (U/L); aspartate aminotransferase (U/L); gamma glutamyl transpeptidase (U/L). Lactate dehydrogenase (UI/L) as markers of hepatic inflammation
Measured: 3 months
Concentration of white blood cells (10exp3/µl)
measured as a marker of inflammation
Measured: 15 days
Concentration of white blood cells (10exp3/µl)
measured as a marker of inflammation
Measured: 3 months
concentration of CRP (c-reactive protein) (mg/dl)
measured as a marker of inflammation
Measured: 15 days
concentration of CRP (c-reactive protein) (mg/dl)
measured as a marker of inflammation
Measured: 3 months
Insulin resistance
HOMA-Homeostasis Model Assessment calculated from fasted glycemia and insulinemia
Measured: 3 months
Concentration of blood lipids
Analysis of circulating lipids : total, LDL and HDL cholesterol (mg/dl), triglycerides (md/dl)
Measured: 3 months
Obesity
Body weight
Measured: 3 months
Adiposity
Fat mass evaluated by bioimpedance measurements
Measured: 3 months
Visceral adiposity
Waist and hip circumference
Measured: 3 months
Secondary outcomes (5)
Measure of the concentration of Akkermansia in the feces (bacterial cells/g of feces)
Metagenomic analysis of the gut bacteria by using sequencing technology and by using quantitative polymerase chain reaction (qPCR).
Measured: 3 months
Gut barrier function
Fecal calprotectin, fecal zonulin, plasma lipopolysaccharides (LPS) binding protein (LBP)
Measured: 3 months
Metabolic endotoxemia
Plasma lipopolysaccharides (LPS) by the limulus amebocyte lysate kinetic chromogenic methodology
Measured: 3 months
Gut microbial-related metabolites in urine
Metabolomic analysis of the bacterial metabolites present in the urine by combining nuclear magnetic resonance (1H-NMR) and mass spectrometry
Measured: 3 months
Gut microbial-related metabolites in plasma
Metabolomic analysis of the bacterial metabolites present in the plasma by combining nuclear magnetic resonance (1H-NMR) and mass spectrometry
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study startDec 2015
- Primary completion20 Feb 2018
- Study completion20 Feb 2018
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 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Patrice D. Cani
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Patrice D. Cani, Université Catholique de Louvain
- Investigators
- Patrice D. Cani, Professor, Study director, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02637115
- Sponsor's protocol ID
- 2015/02JUL/369
- Other IDs
- B403201525111
- Acronym
- Microbes4U
- Status last verified
- May 2019
- First submitted
- 10 Dec 2015
- Last updated
- 17 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Schneeberger M, Everard A, Gomez-Valades AG, Matamoros S, Ramirez S, Delzenne NM, Gomis R, Claret M, Cani PD. Akkermansia muciniphila inversely correlates with the onset of inflammation, altered adipose tissue metabolism and metabolic disorders during obesity in mice. Sci Rep. 2015 Nov 13;5:16643. doi: 10.1038/srep16643.
PubMed 26563823Dao MC, Everard A, Aron-Wisnewsky J, Sokolovska N, Prifti E, Verger EO, Kayser BD, Levenez F, Chilloux J, Hoyles L; MICRO-Obes Consortium; Dumas ME, Rizkalla SW, Dore J, Cani PD, Clement K. Akkermansia muciniphila and improved metabolic health during a dietary intervention in obesity: relationship with gut microbiome richness and ecology. Gut. 2016 Mar;65(3):426-36. doi: 10.1136/gutjnl-2014-308778. Epub 2015 Jun 22.
PubMed 26100928Everard A, Belzer C, Geurts L, Ouwerkerk JP, Druart C, Bindels LB, Guiot Y, Derrien M, Muccioli GG, Delzenne NM, de Vos WM, Cani PD. Cross-talk between Akkermansia muciniphila and intestinal epithelium controls diet-induced obesity. Proc Natl Acad Sci U S A. 2013 May 28;110(22):9066-71. doi: 10.1073/pnas.1219451110. Epub 2013 May 13.
PubMed 23671105Depommier C, Vitale RM, Iannotti FA, Silvestri C, Flamand N, Druart C, Everard A, Pelicaen R, Maiter D, Thissen JP, Loumaye A, Hermans MP, Delzenne NM, de Vos WM, Di Marzo V, Cani PD. Beneficial Effects of Akkermansia muciniphila Are Not Associated with Major Changes in the Circulating Endocannabinoidome but Linked to Higher Mono-Palmitoyl-Glycerol Levels as New PPARalpha Agonists. Cells. 2021 Jan 19;10(1):185. doi: 10.3390/cells10010185.
PubMed 33477821Depommier C, Flamand N, Pelicaen R, Maiter D, Thissen JP, Loumaye A, Hermans MP, Everard A, Delzenne NM, Di Marzo V, Cani PD. Linking the Endocannabinoidome with Specific Metabolic Parameters in an Overweight and Insulin-Resistant Population: From Multivariate Exploratory Analysis to Univariate Analysis and Construction of Predictive Models. Cells. 2021 Jan 5;10(1):71. doi: 10.3390/cells10010071.
PubMed 33466285
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects Associated With the Administration of Akkermansia Muciniphila on Parameters of Metabolic Syndrome Related to Obesity
- ClinicalTrials.gov ID
- NCT02637115
- Acronym / sponsor ID
- Microbes4U / 2015/02JUL/369
- Keywords
- Gut microbiota, Akkermansia muciniphila
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Patrice D. CaniUniversity, hospital or other
- Collaborators
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Study start
- Dec 2015 (actual)
- Primary completion
- 20 Feb 2018 (actual)
- Study completion
- 20 Feb 2018 (actual)
- First posted
- 22 Dec 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.
Overweight and obesity have reached worldwide epidemic level. Both overweight and obesity are characterized by comorbidities such as cardio-metabolic risk factors (i.e., insulin resistance, type 2 diabetes, hypertension, dyslipidemia, low-grade inflammation) representing a major public health problem. Therefore, it is urgent to find a therapeutic solution to target all these metabolic disorders. Among the environmental factors able to influence the individual susceptibility to gain weight and to develop metabolic disorders associated with obesity, more and more evidence show that the trillions of bacteria housed in our gastro-intestinal tract (i.e, gut microbiota) influence host metabolism. The investigators recently discovered a putative interesting microbial candidate, namely Akkermansia muciniphila (Akk). More exactly, we found that the administration of Akkermansia muciniphila reduced body weight gain, fat mass gain, glycemia and inflammatory markers in diet-induced obese mice. Moreover, in overweight/obese patients with cardiovascular risk factors subjected to a calorie restriction diet (calorie restriction diet for 6 weeks and an additional 6 weeks of weight maintenance), a higher abundance of Akkermansia muciniphila was associated with a better cardio-metabolic status in these patients. The investigators also discovered that patients having more Akkermansia muciniphila in their gut before the calorie restriction exhibited a greater improvement in glucose homoeostasis, blood lipids and body composition after calorie restriction. These observations suggested that the administration of Akkermansia muciniphila in overweight or obese people could be a very interesting therapeutic solution. Currently, no human study has investigated the beneficial effects of Akkermansia muciniphila administration on obesity and metabolic disorders. The overall objective of this study is to evaluate the effects associated with the administration of live or heat-killed Akkermansia muciniphila on the metabolic disorders (insulin-resistance, type-2 diabetes, dyslipidemia, inflammation) related to overweight and obesity in humans.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo corresponds to a solution of Phosphate buffer saline (PBS) and glycerol, that is the carrier used in the 3 other groups receiving the bacteria (active arms) |
| Live Akk 9 | Experimental | Dietary Supplement: Live Akk 9Live Akkermansia muciniphila (Akk) at the dose of 10exp9 live bacteria (one billion of live bacteria) per day |
| Live Akk 10 | Experimental | Dietary Supplement: Live Akk 10Live Akkermansia muciniphila (Akk) at the dose of 10exp10 live bacteria (ten billion of live bacteria) per day |
| Killed Akk | Experimental | Dietary Supplement: Killed AkkThis group corresponds to Akkermansia muciniphila that have been heat-killed. The initial quantity of bacteria before the heating procedure was of 10exp10 bacteria. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Aged between 18 and 70 years old
- Caucasian
- Insulin resistance (based on HOMA single-value)
- BMI between 25 and 50 kg/m²
- Metabolic syndrome: presence of at least 3 of the following criteria
Key exclusion criteria (15 listed)
- Acute or chronic progressive or chronic unstabilized diseases
- Alcohol consumption (more than 2 glasses per day)
- Previous bariatric surgery
- Surgery in the 3 months prior the study or surgery planned in the next 6 months
- Pregnancy or pregnancy planned in the next 6 months
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 |
|---|---|---|
| PlaceboConsumption of one dose-sachet per day. This dose-sachet contains a placebo (PBS/Glycerol) | Dietary supplement | Placebo |
| Live Akk 9Consumption of one dose-sachet per day. This dose-sachet contains Live Akkermansia muciniphila (one billion per dose-sachet) | Dietary supplement | Live Akk 9 |
| Live Akk 10Consumption of one dose-sachet per day. This dose-sachet contains Live Akkermansia muciniphila (ten billion per dose-sachet) | Dietary supplement | Live Akk 10 |
| Killed AkkConsumption of one dose-sachet per day. This dose-sachet contains heat-killed Akkermansia muciniphila | Dietary supplement | Killed Akk |
Primary outcome
Tolerance
Time frame: 15 days
self reporting of gastrointestinal symptoms (nausea, bloating, flatulence, cramp, borborygmi and gastric reflux)
Tolerance
Time frame: 3 months
self reporting of gastrointestinal symptoms (nausea, bloating, flatulence, cramp, borborygmi and gastric reflux)
Concentration of urea (mg/dl)
Time frame: 15 days
measure of urea as marker of renal function
Concentration of urea (mg/dl)
Time frame: 3 months
measure of urea as marker of renal function
Glomerular filtration rate (mL/min/1.73m2)
Time frame: 15 days
measure of glomerular filtration rate as marker of renal function
Glomerular filtration rate (mL/min/1.73m2)
Time frame: 3 months
measure of glomerular filtration rate as marker of renal function
Concentration of creatinine (mg/dl)
Time frame: 15 days
measure of creatinine as marker of renal function
Concentration of creatinine (mg/dl)
Time frame: 3 months
measure of creatinine as marker of renal function
Concentration of liver transaminases
Time frame: 15 days
measure of alanine aminotransferase (U/L); aspartate aminotransferase (U/L); gamma glutamyl transpeptidase (U/L). Lactate dehydrogenase (UI/L) as markers of hepatic inflammation
Concentration of liver transaminases
Time frame: 3 months
measure of alanine aminotransferase (U/L); aspartate aminotransferase (U/L); gamma glutamyl transpeptidase (U/L). Lactate dehydrogenase (UI/L) as markers of hepatic inflammation
Concentration of white blood cells (10exp3/µl)
Time frame: 15 days
measured as a marker of inflammation
Concentration of white blood cells (10exp3/µl)
Time frame: 3 months
measured as a marker of inflammation
concentration of CRP (c-reactive protein) (mg/dl)
Time frame: 15 days
measured as a marker of inflammation
concentration of CRP (c-reactive protein) (mg/dl)
Time frame: 3 months
measured as a marker of inflammation
Insulin resistance
Time frame: 3 months
HOMA-Homeostasis Model Assessment calculated from fasted glycemia and insulinemia
Concentration of blood lipids
Time frame: 3 months
Analysis of circulating lipids : total, LDL and HDL cholesterol (mg/dl), triglycerides (md/dl)
Obesity
Time frame: 3 months
Body weight
Adiposity
Time frame: 3 months
Fat mass evaluated by bioimpedance measurements
Visceral adiposity
Time frame: 3 months
Waist and hip circumference
5 secondary outcomes
Measure of the concentration of Akkermansia in the feces (bacterial cells/g of feces)
Time frame: 3 months
Gut barrier function
Time frame: 3 months
Metabolic endotoxemia
Time frame: 3 months
Gut microbial-related metabolites in urine
Time frame: 3 months
Gut microbial-related metabolites in plasma
Time frame: 3 months
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 17 May 2019.
- Background: PubMed 26563823Schneeberger M, Everard A, Gomez-Valades AG, Matamoros S, Ramirez S, Delzenne NM, Gomis R, Claret M, Cani PD. Akkermansia muciniphila inversely correlates with the onset of inflammation, altered adipose tissue metabolism and metabolic disorders during obesity in mice. Sci Rep. 2015 Nov 13;5:16643. doi: 10.1038/srep16643.
- Background: PubMed 26100928Dao MC, Everard A, Aron-Wisnewsky J, Sokolovska N, Prifti E, Verger EO, Kayser BD, Levenez F, Chilloux J, Hoyles L; MICRO-Obes Consortium; Dumas ME, Rizkalla SW, Dore J, Cani PD, Clement K. Akkermansia muciniphila and improved metabolic health during a dietary intervention in obesity: relationship with gut microbiome richness and ecology. Gut. 2016 Mar;65(3):426-36. doi: 10.1136/gutjnl-2014-308778. Epub 2015 Jun 22.
- Background: PubMed 23671105Everard A, Belzer C, Geurts L, Ouwerkerk JP, Druart C, Bindels LB, Guiot Y, Derrien M, Muccioli GG, Delzenne NM, de Vos WM, Cani PD. Cross-talk between Akkermansia muciniphila and intestinal epithelium controls diet-induced obesity. Proc Natl Acad Sci U S A. 2013 May 28;110(22):9066-71. doi: 10.1073/pnas.1219451110. Epub 2013 May 13.
- Derived from this study: PubMed 33477821Depommier C, Vitale RM, Iannotti FA, Silvestri C, Flamand N, Druart C, Everard A, Pelicaen R, Maiter D, Thissen JP, Loumaye A, Hermans MP, Delzenne NM, de Vos WM, Di Marzo V, Cani PD. Beneficial Effects of Akkermansia muciniphila Are Not Associated with Major Changes in the Circulating Endocannabinoidome but Linked to Higher Mono-Palmitoyl-Glycerol Levels as New PPARalpha Agonists. Cells. 2021 Jan 19;10(1):185. doi: 10.3390/cells10010185.
- Derived from this study: PubMed 33466285Depommier C, Flamand N, Pelicaen R, Maiter D, Thissen JP, Loumaye A, Hermans MP, Everard A, Delzenne NM, Di Marzo V, Cani PD. Linking the Endocannabinoidome with Specific Metabolic Parameters in an Overweight and Insulin-Resistant Population: From Multivariate Exploratory Analysis to Univariate Analysis and Construction of Predictive Models. Cells. 2021 Jan 5;10(1):71. doi: 10.3390/cells10010071.
- Individual participant dataSharing planned: Undecided
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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.
Patrice D. Cani, Professor study director
Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Live Akk 9, Live Akk 10 and Killed Akk in people with Metabolic Syndrome x and Glucose Metabolism Disorders, run by Patrice D. Cani at 1 site in Belgium.
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 11 inclusion and 15 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 17 May 2019. 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 Belgium. 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?
Tolerance (time frame: 15 days). The study lists 19 primary outcomes in all. 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 NCT02637115, 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 May 2019.