OverweightPINEAPPLNCT06355544
Individual Factors Related to Chronic Low-grade Inflammation and Cardiometabolic Disease Risk
An observational study of Overweight and Obesity, run by Integrative Phenomics.
Trial summary
The goal of this observational study is to learn about low-grade inflammation in healthy individuals and individuals with overweight or obesity. The main questions it aims to answer are: Whether it is possible to predict low-grade inflammation What are the medical, biological, and lifestyle variables related to… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity, Metabolic Syndrome
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- Apr 2024to 30 Jun 2026
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Existing or new patients with overweight or obesity from primary care at La Pitié-Salpetriere Hospital in Paris, Marseille Public Hospital, Colmar Civil Hospital, Bordeaux University Hospital. Healthy volunteers throughout France.
Who may be able to join
- Male or female between the ages of 18 and 70 included,
- One of the following two criteria:
- Clinically at-risk group Body Mass Index between 25 (included) and up to 35 kg/m2 (excluded)
- Non-clinically at-risk group Body Mass Index between 18.5 (included) and up to 25 kg/m2 (excluded) and absence of metabolic syndrome criteria
- Subject covered by social security or a similar system.
- Ability to use a mobile phone application on a daily basis (food intake).
- Subject, after being informed of the contents of this study, fully understanding and accepting its purpose; and able to personally sign a written informed consent
Who cannot join
- Subject with diagnosed inflammatory disease or infection-related inflammation (viral or bacterial) or medical history (viral) within the last 2 months:
- Rheumatoid arthritis, reactive or psoriatic arthritis (non-osteoarthritis)
- Inflammatory bowel disease (IBD) (Crohn\'s disease or ulcerative colitis) or irritable bowel syndrome
- Systemic lupus erythematosus
- Uncontrolled psoriasis
- Viral hepatitis or ongoing viral infection
Show all 25Show fewer
- Seasonal virus (influenza-like illness)
- Subjects who have taken antibiotics in the last 2 months
- Subject under treatment within the last 2 months of an:
- Antiviral (for HIV, hepatitis, influenza, chickenpox/shingles)
- Oral, topical, or injectable treatment of a drug that modulates the inflammatory response (e.g. Corticosteroid, non-steroidal anti-inflammatory drugs (e.g. ibuprofen, diclofenac, celecoxib, naproxen, aspirin, etc.)
- Dietary supplement that can modulate the inflammatory response (e.g.
- Omega 3 fatty acid, curcuma/turmeric, probiotic, prebiotics)
- Subject with diabetes (type 1 or 2) known treated prior to the inclusion visit (specifically subjects recently diagnosed or diagnosed with diabetes at the time of the laboratory assessment may be retained in the study if they are not taking anti-diabetic treatment): i.e. exclusion of subject with diabetes diagnosed with fasting blood glucose ≥ 126 mg/dL (7.0 mmol measured twice/L OR glycated hemoglobin ≥ 6.5% (48 mmol/mol) AND anti-diabetic therapy (metformin, GLP-1 receptor agonist, insulin, sulphonylurea, alpha-glucosidase inhibitor)
- Subject with severe or unstable hepatic, renal, cardiovascular, respiratory, endocrine, or metabolic disorders or cancer diagnosed with or without treatment
- Subject suffering from gastrointestinal disorders resulting in the use of laxatives or drugs for intestinal transit (e.g., loperamide) in the last 2 months.
- Subject with a complication or procedure in the last 2 months that could result in inflammation
- Minor or acute tendonitis, sprain, or contusion
- Severe contusion (e.g. Bone contusion)
- Major or invasive surgery
- Subject in a situation that, in the opinion of the investigator, could interfere with optimal participation in the present study or pose a particular risk to the subject.
- Subject currently participating in an interventional clinical study
- Subject not affiliated to the Social Security scheme
- Subject who did not comply with the exclusion period of the study in which they would have previously participated
- Subject not being able to use the internet
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Integrative and Personalized Lifestyle Approach to Reduce Low-Grade Inflammation in People at Risk of Cardiometabolic Diseases
The goal of this observational study is to learn about low-grade inflammation in healthy individuals and individuals with overweight or obesity.
The main questions it aims to answer are:
- Whether it is possible to predict low-grade inflammation
- What are the medical, biological, and lifestyle variables related to low-grade inflammation?
Participants will be asked to:
- Attend a general medical visit to collect vital signs, anthropometric measurements, and collect blood samples.
- Complete questionnaires and collect a stool sample at home.
Read the detailed description
Cardiometabolic diseases (CMDs) are a heterogeneous spectrum of nutrition-related chronic diseases, ranging from obesity to diabetes and, ultimately, to acute and chronic cardiovascular diseases. Once established, these diseases are usually irreversible and evolve over time. Since these diseases are born out of societal and lifestyle changes, the cornerstones of prevention and management are changes in nutrition and lifestyle. This inevitable increase in CMDs, including obesity, particularly affects socially vulnerable populations.
The etiology of cardiometabolic diseases is complex and involves environmental, biological and genetic elements. Weight gain is at the heart of these pathologies: it frequently precedes their development or contributes to the progression of these diseases. To this end, even modest weight loss is suggested as an important line of prevention or treatment of cardiometabolic diseases. For example, diabetes remission can be achieved with weight loss and is directly correlated with the amount of weight lost. Despite the beneficial effects of weight loss on preventing the progression of cardiometabolic diseases, maintaining weight loss is difficult, with only 30% of individuals achieving long-term weight loss (5 years). The same is true with the development of anti-obesity treatments (new analogues of glucagon-like peptide 1 (GLP1)); Discontinuation of treatment is accompanied by weight gain. In the case of diabetes, weight gain is associated with the recurrence of previously remitted diabetes.
Chronic low-grade inflammation is tightly linked with obesity and a central feature of cardiometabolic diseases and associated diseases. Furthermore, it paves the way for future comorbidities. This inflammation is characterized by a rise of systemic or circulating inflammatory molecules. However, no single cytokine can reflect the inflammatory state seen in cardiometabolic diseases and these systemic factors are highly variable from subject to subject. Recently, combinatorial indexes, using multiple inflammatory markers have been strongly associated with coronary risks and Metabolic alterations.
Over the past 10 years, the gut microbiome has become a recognized contributor to our metabolic health. Accumulating evidence has shown that the gut microbiome strongly reflects environmental and lifestyle changes (including nutrition) by altering its diversity and composition as well as its functions by producing molecules that interact with host organs, including the brain. The excess or deficit production of molecules produced by the microbiota, bacterial metabolites (such as trimethylamine oxide (TMAO), Imidazole propionate, branched-chain amino acids (BCAAs), or short-chain fatty acids (SCFAs), etc.) are molecules implicated in the link between the environment, microbiota and metabolic and inflammatory disturbances.
Current strong evidence indicates that the gut microbiota is altered early in people with inflammatory diseases that include CMDs. Relationships between the inflammatory component of the diet and the gut microbiome have also been identified.
In an effort to predict chronic-low grade inflammation in a real-world population and decipher the relationships between chronic low-grade inflammation and individual factors, comprising lifestyle, diet, behavior, environment, the gut microbiome, and health-related clinical data, the present study recruits a cohort of participants across age, sex, body mass index, and metabolic health spectra. Chronic low-grade inflammation markers of interest will be measured to establish a multi-component index of inflammation relative in the population.
- Conditions
- Overweight, Obesity, Metabolic Syndrome, Healthy, Low-grade Inflammation, Normal Weight Adults
- Keywords
- nutrition, microbiome, lifestyle factors, low-grade inflammation, personalized nutrition, precision nutrition
- Medical subject headings
- Overweight, Obesity, Metabolic Syndrome, Hypertension, Hypercholesterolemia, Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Not clinically at-risk | Individuals with BMI between 18.5 kg/m2 (included) and 25 kg/m2 (excluded) and without risk factors for metabolic syndrome | |
| Clinically at-risk | Individuals with BMI between 25 (included) and 35 kg/m2 (excluded) with or without metabolic syndrome and without treated type-2 diabetes mellitus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low-grade inflammation
Assessed as a z-score composed of six markers (C reactive protein (CRP), interleukin (IL)-6, serum amyloid-A (SAA), soluble intracellular adhesion molecule (sICAM), tumor necrosis factor alpha (TNF)-alpha) and categorized into 3 tertiles: Low/ Moderate/High
Measured: Baseline
Secondary outcomes (47)
Gut microbiome metabolites
Consumption and production in mmol/day assessed through in silico metabolic modeling
Measured: Baseline
Fasting glucose
Serum glucose in mg/dl
Measured: Baseline
Stool microbiome composition
Relative abundance of microbiome taxonomies (Phyla, Order, Class, Family, Genus, Species), metagenomic species (MGS), and co-abundance genes (CAGs) in stool samples assessed through shot-gun sequencing
Measured: Baseline
Stool microbiome functional pathways
Relative abundances of microbiome functional pathways assessed through metagenomics and in silico metabolic modeling
Measured: Baseline
Systolic blood pressure
mmHg
Measured: Baseline
Resting heart rate
Beats per minute
Measured: Baseline
Serum glycated hemoglobin (HbA1c)
Percentage of HbA1c or mmol/L
Measured: Baseline
Diastolic blood pressure
millimeters mercury (mmHg)
Measured: Baseline
Height
Centimeters
Measured: Baseline
Waist circumference
Centimeters
Measured: Baseline
Neck circumference
Centimeters
Measured: Baseline
Hip circumference
Centimeters
Measured: Baseline
Body fat mass
Percentage of bodymass measured by impedance
Measured: Baseline
Water body mass
Percentage of body mass measured by impedance
Measured: Baseline
Lean body mass
Percentage of body mass measured by impedance
Measured: Baseline
Serum fasting low-density lipoprotein
mmol/L
Measured: Baseline
Fasting serum high-density lipoprotein
mmol/L
Measured: Baseline
Fasting total serum cholesterol
mmol/L
Measured: Baseline
Consumption of dietary macronutrients
Dietary macronutrient consumption assessed in g/day from dietary records and food frequency questionnaires
Measured: Baseline
Consumption of dietary micronutrients
Daily micronutrient consumption (mg/d) assessed by dietary records and food frequency questionnaire
Measured: Baseline
Consumption of dietary metabolites
Dietary metabolite consumption expressed in mmol/day assessed by dietary records and food frequency questionnaire
Measured: Baseline
Food item consumption
Consumption of food items in g/day assessed by dietary records and food frequency questionnaires
Measured: Baseline
Food group consumption
Consumption of food groups in g/day assessed by dietary records and food frequency questionnaires
Measured: Baseline
Body weight
Kilograms
Measured: Baseline
Serum Alanine Transaminase (ALT)
Serum Units per Liter (U/L)
Measured: Baseline
Serum Aspartate Aminotransferase (ALT)
Serum Units per Liter (U/L)
Measured: Baseline
Serum gamma-glutamyl transferase (GGT)
Serum Units per Liter (U/L)
Measured: Baseline
Fasting serum triglycerides
mmol/L
Measured: Baseline
Fasting serum uric acid
mmol/L
Measured: Baseline
Fasting serum creatinine
mmol/L
Measured: Baseline
Fasting serum insulin
mmol/L
Measured: Baseline
Blood hemoglobin
grams per 100 milliliters (g/100ml)
Measured: Baseline
Blood hematocrit
Percentage (%) of whole blood sample
Measured: Baseline
Red blood cells
Cell counts in 10^9 per liter (10^9/L)
Measured: Baseline
Red blood cell volume
Mean volume in cubic micrometers (um^3)
Measured: Baseline
Hemoglobin relative red blood cell size
Mean relative hemoglobin relative to red blood cell size in percentage
Measured: Baseline
Mean cell hemoglobin (MCH)
Mass of hemoglobin per red blood cell in picograms (pg)
Measured: Baseline
Blood platelets
Cell counts expressed in billions/L (10^9/L)
Measured: Baseline
White blood cells
Cell counts expressed in billions/L (10^9/L) and differential
Measured: Baseline
Perceived quality of life
Self-perceived measurements of mental, physical, emotional, social, and general quality of life, fatigue, energy assessed by questionnaire
Measured: Baseline
Eating behavior
Self-perceived emotional, uncontrolled, and eating restriction assessed by questionnaire
Measured: Baseline
Physical activity
Total, leisure, work, and sports physical activity assessed by questionnaire
Measured: Baseline
Stool consistency
Stool consistency assessed and self-reported by Bristol Stool Scale
Measured: Baseline
Stress
Self-perceived stress assessed by questionnaire
Measured: Baseline
Deprivation
Economic, material, and social deprivation assessed by questionnaire
Measured: Baseline
Sleep
Sleep latency, duration, efficiency, quality, disturbances, and daytime dysfunction assessed by questionnaire
Measured: Baseline
Sleep apnea
Binary value (yes/no) assessed from questionnaire
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study startApr 2024 (estimated)
- Primary completion30 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Integrative Phenomics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Assistance Publique - Hôpitaux de Paris, Assistance Publique Hopitaux De Marseille, University Hospital, Bordeaux, Centre Hospitalier Universitaire Dijon, Institut Pasteur de Lille, Hopitaux Civils de Colmar
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06355544
- Sponsor's protocol ID
- PINEAPPL2023
- Other IDs
- 2023-A02494-41
- Acronym
- PINEAPPL
- Status last verified
- Apr 2024
- First submitted
- 28 Mar 2024
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative and Personalized Lifestyle Approach to Reduce Low-Grade Inflammation in People at Risk of Cardiometabolic Diseases
- ClinicalTrials.gov ID
- NCT06355544
- Acronym / sponsor ID
- PINEAPPL / PINEAPPL2023
- Conditions
- Overweight, Obesity, Metabolic Syndrome, Healthy, Low-grade Inflammation, Normal Weight Adults
- Keywords
- nutrition, microbiome, lifestyle factors, low-grade inflammation, personalized nutrition, precision nutrition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Integrative PhenomicsIndustry (pharma, biotech, devices)
- Collaborators
- Assistance Publique - Hôpitaux de Paris, Assistance Publique Hopitaux De Marseille, University Hospital, Bordeaux, Centre Hospitalier Universitaire Dijon, Institut Pasteur de Lille, Hopitaux Civils de Colmar
- Study start
- Apr 2024 (estimated)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 9 Apr 2024 (actual)
- 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 goal of this observational study is to learn about low-grade inflammation in healthy individuals and individuals with overweight or obesity.
The main questions it aims to answer are:
- Whether it is possible to predict low-grade inflammation
- What are the medical, biological, and lifestyle variables related to low-grade inflammation?
Participants will be asked to:
- Attend a general medical visit to collect vital signs, anthropometric measurements, and collect blood samples.
- Complete questionnaires and collect a stool sample at home.
Detailed description
Cardiometabolic diseases (CMDs) are a heterogeneous spectrum of nutrition-related chronic diseases, ranging from obesity to diabetes and, ultimately, to acute and chronic cardiovascular diseases. Once established, these diseases are usually irreversible and evolve over time. Since these diseases are born out of societal and lifestyle changes, the cornerstones of prevention and management are changes in nutrition and lifestyle. This inevitable increase in CMDs, including obesity, particularly affects socially vulnerable populations.
The etiology of cardiometabolic diseases is complex and involves environmental, biological and genetic elements. Weight gain is at the heart of these pathologies: it frequently precedes their development or contributes to the progression of these diseases. To this end, even modest weight loss is suggested as an important line of prevention or treatment of cardiometabolic diseases. For example, diabetes remission can be achieved with weight loss and is directly correlated with the amount of weight lost. Despite the beneficial effects of weight loss on preventing the progression of cardiometabolic diseases, maintaining weight loss is difficult, with only 30% of individuals achieving long-term weight loss (5 years). The same is true with the development of anti-obesity treatments (new analogues of glucagon-like peptide 1 (GLP1)); Discontinuation of treatment is accompanied by weight gain. In the case of diabetes, weight gain is associated with the recurrence of previously remitted diabetes.
Chronic low-grade inflammation is tightly linked with obesity and a central feature of cardiometabolic diseases and associated diseases. Furthermore, it paves the way for future comorbidities. This inflammation is characterized by a rise of systemic or circulating inflammatory molecules. However, no single cytokine can reflect the inflammatory state seen in cardiometabolic diseases and these systemic factors are highly variable from subject to subject. Recently, combinatorial indexes, using multiple inflammatory markers have been strongly associated with coronary risks and Metabolic alterations.
Over the past 10 years, the gut microbiome has become a recognized contributor to our metabolic health. Accumulating evidence has shown that the gut microbiome strongly reflects environmental and lifestyle changes (including nutrition) by altering its diversity and composition as well as its functions by producing molecules that interact with host organs, including the brain. The excess or deficit production of molecules produced by the microbiota, bacterial metabolites (such as trimethylamine oxide (TMAO), Imidazole propionate, branched-chain amino acids (BCAAs), or short-chain fatty acids (SCFAs), etc.) are molecules implicated in the link between the environment, microbiota and metabolic and inflammatory disturbances.
Current strong evidence indicates that the gut microbiota is altered early in people with inflammatory diseases that include CMDs. Relationships between the inflammatory component of the diet and the gut microbiome have also been identified.
In an effort to predict chronic-low grade inflammation in a real-world population and decipher the relationships between chronic low-grade inflammation and individual factors, comprising lifestyle, diet, behavior, environment, the gut microbiome, and health-related clinical data, the present study recruits a cohort of participants across age, sex, body mass index, and metabolic health spectra. Chronic low-grade inflammation markers of interest will be measured to establish a multi-component index of inflammation relative in the population.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Not clinically at-risk | – | –Individuals with BMI between 18.5 kg/m2 (included) and 25 kg/m2 (excluded) and without risk factors for metabolic syndrome |
| Clinically at-risk | – | –Individuals with BMI between 25 (included) and 35 kg/m2 (excluded) with or without metabolic syndrome and without treated type-2 diabetes mellitus |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Existing or new patients with overweight or obesity from primary care at La Pitié-Salpetriere Hospital in Paris, Marseille Public Hospital, Colmar Civil Hospital, Bordeaux University Hospital. Healthy volunteers throughout France.
Key inclusion criteria (7 listed)
- Male or female between the ages of 18 and 70 included,
- One of the following two criteria:
- Clinically at-risk group Body Mass Index between 25 (included) and up to 35 kg/m2 (excluded)
- Non-clinically at-risk group Body Mass Index between 18.5 (included) and up to 25 kg/m2 (excluded) and absence of metabolic syndrome criteria
- Subject covered by social security or a similar system.
Key exclusion criteria (25 listed)
- Subject with diagnosed inflammatory disease or infection-related inflammation (viral or bacterial) or medical history (viral) within the last 2 months:
- Rheumatoid arthritis, reactive or psoriatic arthritis (non-osteoarthritis)
- Inflammatory bowel disease (IBD) (Crohn\'s disease or ulcerative colitis) or irritable bowel syndrome
- Systemic lupus erythematosus
- Uncontrolled psoriasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Low-grade inflammation
Time frame: Baseline
Assessed as a z-score composed of six markers (C reactive protein (CRP), interleukin (IL)-6, serum amyloid-A (SAA), soluble intracellular adhesion molecule (sICAM), tumor necrosis factor alpha (TNF)-alpha) and categorized into 3 tertiles: Low/ Moderate/High
47 secondary outcomes
Gut microbiome metabolites
Time frame: Baseline
Fasting glucose
Time frame: Baseline
Stool microbiome composition
Time frame: Baseline
Stool microbiome functional pathways
Time frame: Baseline
Systolic blood pressure
Time frame: Baseline
Resting heart rate
Time frame: Baseline
Serum glycated hemoglobin (HbA1c)
Time frame: Baseline
Diastolic blood pressure
Time frame: Baseline
Height
Time frame: Baseline
Waist circumference
Time frame: Baseline
Neck circumference
Time frame: Baseline
Hip circumference
Time frame: Baseline
Body fat mass
Time frame: Baseline
Water body mass
Time frame: Baseline
Lean body mass
Time frame: Baseline
Serum fasting low-density lipoprotein
Time frame: Baseline
Fasting serum high-density lipoprotein
Time frame: Baseline
Fasting total serum cholesterol
Time frame: Baseline
Consumption of dietary macronutrients
Time frame: Baseline
Consumption of dietary micronutrients
Time frame: Baseline
Consumption of dietary metabolites
Time frame: Baseline
Food item consumption
Time frame: Baseline
Food group consumption
Time frame: Baseline
Body weight
Time frame: Baseline
Serum Alanine Transaminase (ALT)
Time frame: Baseline
Serum Aspartate Aminotransferase (ALT)
Time frame: Baseline
Serum gamma-glutamyl transferase (GGT)
Time frame: Baseline
Fasting serum triglycerides
Time frame: Baseline
Fasting serum uric acid
Time frame: Baseline
Fasting serum creatinine
Time frame: Baseline
Fasting serum insulin
Time frame: Baseline
Blood hemoglobin
Time frame: Baseline
Blood hematocrit
Time frame: Baseline
Red blood cells
Time frame: Baseline
Red blood cell volume
Time frame: Baseline
Hemoglobin relative red blood cell size
Time frame: Baseline
Mean cell hemoglobin (MCH)
Time frame: Baseline
Blood platelets
Time frame: Baseline
White blood cells
Time frame: Baseline
Perceived quality of life
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight and Obesity, run by Integrative Phenomics.
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 25 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 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 Karine Clément, MD, PhD (33142177031, karine.clement@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low-grade inflammation (time frame: Baseline). 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 Apr 2024; AzTrials last refreshed its copy on 26 Oct 2026.