[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658183":3},{"organization":4,"outcomesModule":7,"designInfo":165,"detailedDescription":172,"studyPopulation":164,"armGroups":173,"interventions":192,"overallOfficials":164,"centralContacts":216,"locations":226,"responsibleParty":304,"collaborators":306,"id":319,"slug":320,"hasResults":321,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":325,"eligibilityCriteria":326,"healthyVolunteers":321,"sex":327,"minAge":328,"maxAge":329,"enrollmentInfo":330,"targetDuration":164,"studyType":333,"phases":334,"briefSummary":336,"conditions":337,"keywords":341,"overallStatus":349,"whyStopped":164,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":359},{"fullName":5,"class":6},"Institut National de la Santé Et de la Recherche Médicale, France","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":164},[9],{"measure":10,"description":11,"timeFrame":12},"Comparison of changes in the percentage of PD-1⁺ CD4⁺ T cells in peripheral blood mononuclear cells between baseline and after 3 month of nutritional intervention","The first endpoint will be evaluated by calculating the change (Δ) in the percentage of PD-1⁺ CD4⁺ T cells between baseline and month 3 to determine the effect of each nutritional intervention. PBMCs will be isolated from peripheral blood samples locally in each center and then analyzed, centralized by flow cytometry to quantify the percentage of PD-1⁺ CD4⁺ T cells.","Baseline and 3-months (after the nutritional intervention)",[14,18,22,25,28,31,34,37,39,42,45,48,51,54,57,60,63,66,69,72,75,78,81,84,87,90,93,96,99,102,105,108,111,114,117,120,123,125,128,131,134,137,140,143,146,149,152,156,160],{"measure":15,"description":16,"timeFrame":17},"Comparison of changes in the percentage of PD-1⁺ CD4⁺ T cells in peripheral blood mononuclear cells between baseline and after 3 month of nutritional intervention and 3 month of follow-up","The endpoint will be evaluated by calculating the change (Δ) in the percentage of PD-1⁺ CD4⁺ T cells between baseline and month 6. Group comparisons will be based on these changes (Δ values) to determine the effect of each nutritional intervention. PBMCs will be isolated from peripheral blood samples locally in each center and then analyzed, centralized by flow cytometry to quantify the percentage of PD-1⁺ CD4⁺ T cells.","Baseline and 6 months (after 3 months of nutritional intervention and 3 months of follow-up)",{"measure":19,"description":20,"timeFrame":21},"Comparison of immune cell phenotyping at baseline, month 3 and month 6 in peripheral blood mononuclear cells between the nutritional interventions","The endpoint will be evaluated by calculating the change (Δ) in cell phenotyping between baseline and month 3, baseline and month 6 and month 3 and month 6 to determine the effect of each nutritional intervention. PBMCs will be isolated from peripheral blood samples locally in each center and then analyzed, centralized by flow and mass cytometry.","Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6",{"measure":23,"description":24,"timeFrame":21},"Comparison of immune checkpoint proteins at baseline, month 3 and month 6 in peripheral blood mononuclear cells between the nutritional interventions","The endpoint will be evaluated by calculating the change (Δ) in immune checkpoint proteins between baseline and month 3 and baseline and month 6 to determine the effect of each nutritional intervention. PBMCs will be isolated from peripheral blood samples locally in each center and then analyzed, centralized by flow cytometry and mass cytometry",{"measure":26,"description":27,"timeFrame":21},"Comparison of concentration of immunoglobulines G (IgG) in serum at baseline, month 3 and month 6 between the nutritional interventions","The endpoint will be evaluated by calculating the change (Δ) in the concentration of Immunoglobulines G in serum between baseline and month 3 and baseline and month 6. Group comparisons will be based on these changes (Δ values) to determine the effect of each nutritional intervention.",{"measure":29,"description":30,"timeFrame":21},"Comparison of cytokines and hsCRP at baseline, month 3 and month 6 in serum between the nutritional interventions","The endpoint will be evaluated by calculating the change (Δ) in the concentration of cytokines by Olink-multi-immune\u002Finflammatory markers and hsCRP, between baseline and month 3 and baseline and month 6. Group comparisons will be based on these changes (Δ values) to determine the effect of each nutritional intervention.",{"measure":32,"description":33,"timeFrame":21},"Comparison of the ratio immunoglobulines A fecal\u002F immunoglobulines G fecal at baseline, month 3 and month 6 between the nutritional interventions","The endpoint will be evaluated by calculating the change (Δ) in the ratio IgA\u002FIgG fecal by IgA and IgG binding pattern for microbiota between baseline and month 3 and baseline and month 6. Group comparisons will be based on these changes (Δ values) to determine the effect of each nutritional intervention.",{"measure":35,"description":36,"timeFrame":21},"Comparison of low-grade inflammation and immune-profile at baseline, month 3 and month 6 between the nutritional interventions","The endpoint will be evaluated by multiplex profiling of more than 750 circulating inflammatory and organ-specific proteins (Olink exploratory panels). Group comparisons will be based on the changes in the profile (Δ values) to determine the effect of each nutritional intervention.",{"measure":38,"description":36,"timeFrame":21},"Comparison of proteomics signatures linked to immune and organ-specific proteins at baseline, month 3 and month 6 between the nutritional interventions",{"measure":40,"description":41,"timeFrame":21},"Comparison of glyco-immune checkpoint profile at baseline, month 3 and month 6 between the nutritional interventions","The glyco-immune checkpoint profiling in blood, PBMCs and adipose tissue will be evaluated with glycan technology and next-generation SUGAR-seq technology.\n\nGroup comparisons will be based on the changes in the profile (Δ values) to determine the effect of each nutritional intervention.",{"measure":43,"description":44,"timeFrame":21},"Comparison of antigen stimulation and serology at baseline, month 3 and month 6 between the nutritional interventions","The outcome will be assessed from PBMC with co-culture test with CSA and nutriments in a subsample of participants from Lyon site. The following parameters will be studied: markers of helper and cytotoxic T-cell functions",{"measure":46,"description":47,"timeFrame":21},"Comparison of gut microbiota composition, diversity and functional capacity at baseline, month 3 and month 6 between the nutritional interventions","Metagenomics will be performed by shotgun at baseline, month 3 and month 6 to assess and compare the nutritional interventions.",{"measure":49,"description":50,"timeFrame":21},"Comparison of gut barrier integrity at baseline, month 3 and month 6 between the nutritional interventions","Gut barrier integrity will be assessed by the concentration of plasma lipopolysaccharide-binding protein (LBP) in plasma at baseline, month 3 and month 6 to assess and compare the three nutritional interventions.",{"measure":52,"description":53,"timeFrame":21},"Comparison of gut permeability (fecal zonulin) at baseline, month 3 and month 6 between the nutritional interventions","Gut permability will be assessed by the concentration of fecal zonulin at baseline, month 3 and month 6 to assess and compare the three nutritional interventions.",{"measure":55,"description":56,"timeFrame":21},"Comparison of short-chain fatty acids (SCFAs) profil at baseline, month 3 and month 6 between the nutritional interventions","SCFAs profil will be assessed by CGMS in plasma and in feces at baseline, month 3 and month 6 to assess and compare the three nutritional interventions.",{"measure":58,"description":59,"timeFrame":21},"Comparison of metabolomics profil at baseline, month 3 and month 6 between the nutritional interventions","Target metabolomics will be done in plasma at baseline, month 3 and month 6 to assess metabolomics profil and compare the three nutritional interventions.",{"measure":61,"description":62,"timeFrame":21},"Comparison of fecal pH at baseline, month 3 and month 6 between the nutritional interventions","Fecal pH will be assessed at baseline, month 3 and month 6 to compare the three nutritional interventions.",{"measure":64,"description":65,"timeFrame":21},"Blood pressure at baseline, month 3 and month 6 between the nutritional interventions","Blood presure will be assessed at baseline, month 3 and month 6 to compare the three nutritional interventions.",{"measure":67,"description":68,"timeFrame":21},"Resting heart rate at baseline, month 3 and month 6 between the nutritional interventions","Resting heart rate will be assessed at baseline, month 3 and month 6 to compare the three nutritional interventions.",{"measure":70,"description":71,"timeFrame":21},"Body mass index at baseline, month 3 and month 6 between the nutritional interventions","Body mass index will be assessed at baseline, month 3 and month 6 to compare the three nutritional interventions.",{"measure":73,"description":74,"timeFrame":21},"Waist circumferences, hip circumferences and waist\u002Fhip ratio at baseline, month 3 and month 6 between the nutritional interventions","Waist circumferences, hip circumferences and waist\u002Fhip ratio will be assessed at baseline, month 3 and month 6 to compare the three nutritional interventions.",{"measure":76,"description":77,"timeFrame":21},"Body composition at baseline, month 3 and month 6 between the nutritional interventions","Body composition (lean and fat mass) will be assessed by bio-impedancemetry at baseline, month 3 and month 6 to compare the three nutritional interventions.",{"measure":79,"description":80,"timeFrame":21},"Energy metabolism at baseline, month 3 and month 6 between the nutritional interventions","Energy metabolism (Resting Metabolic Rate) will be assessed by indirect calorimetry at baseline, month 3 and month 6 to compare the three nutritional interventions.",{"measure":82,"description":83,"timeFrame":21},"Glycemia fasting at baseline, month 3 and month 6 between the nutritional interventions","Glycemia fasting will be assessed at baseline, month 3 and month 6 to compare the three nutritional interventions.",{"measure":85,"description":86,"timeFrame":21},"Insulin fasting at baseline, month 3 and month 6 between the nutritional interventions","Insulin fasting will be assessed at baseline, month 3 and month 6 to compare the three nutritional interventions.",{"measure":88,"description":89,"timeFrame":21},"Insulin resistance at baseline, month 3 and month 6 between the nutritional interventions","Insulin resistance will be assessed with the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) at baseline, month 3 and month 6 to compare the three nutritional interventions.",{"measure":91,"description":92,"timeFrame":21},"Lipid profile fasting at baseline, month 3 and month 6 between the nutritional interventions","Lipid profile including: cholesterol, LDL, HDL, trigycerides, non-esterified fatty acids, and ApoB fasting will be assessed at baseline, month 3 and month 6 to compare the three nutritional interventions.",{"measure":94,"description":95,"timeFrame":21},"Fatty acid profile at baseline, month 3 and month 6 between the nutritional interventions","Fatty acid profile will be assessed in adipose tissue at baseline, month 3 and month 6 to compare the three nutritional interventions in a subsample included in Lyon.",{"measure":97,"description":98,"timeFrame":21},"Liver health at baseline, month 3 and month 6 between the nutritional interventions","Liver health will be assessed with the level in plasma of alanine aminotransferase (ALT), aspartate aminotransferase (AST) and gamma-glutamyl transferase (GGT) :at baseline, month 3 and month 6 to compare the three nutritional interventions.",{"measure":100,"description":101,"timeFrame":21},"Appetite-regulating hormones at baseline, month 3 and month 6 between the nutritional interventions","Level of adiponectin and leptin fasting hormones will be assessed at baseline, month 3 and month 6 to compare the three nutritional interventions.",{"measure":103,"description":104,"timeFrame":21},"Glucose kinetic after meal-test stimulation at baseline, month 3 and month 6 between the nutritional interventions","Glycemia will be assessed at t-30, t0, t15, t30, t45, t60, t90, t120, t180 and t240. The followings indicators will be calculated: maximum, minimum, times at peak or nadir, total and incremental AUCs (0-120, 120-240 and 0-240 min) during the postprandial period (meal-test).",{"measure":106,"description":107,"timeFrame":21},"Insulin kinetic after meal-test stimulation at baseline, month 3 and month 6 between the nutritional interventions","Insulin will be assessed at t-30, t0, t15, t30, t45, t60, t90, t120, t180 and t240. The followings indicators will be calculated: maximum, minimum, times at peak or nadir, total and incremental AUCs (0-120, 120-240 and 0-240 min) during the postprandial period (meal-test).",{"measure":109,"description":110,"timeFrame":21},"Triglycerides kinetic after meal-test stimulation at baseline, month 3 and month 6 between the nutritional interventions","Triglycerides will be assessed at t-30, t0, t60, t120 and t240. The followings indicators will be calculated: maximum, minimum, times at peak or nadir, total and incremental AUCs (0-120, 120-240 and 0-240 min) during the postprandial period (meal-test).",{"measure":112,"description":113,"timeFrame":21},"Dietary intake of food groups at baseline, month 3 and month 6 between the nutritional interventions","Main food groups consumption will be assessed with 3 days of dietary records and validated Food Frequency Questionnaire (FFQ) filled in at baseline, month 3 and month 6.",{"measure":115,"description":116,"timeFrame":21},"Daily mean of calorie, macronutriment and micronutriments intakes at baseline, month 3 and month 6 between the nutritional interventions","Daily mean of calorie, macronutriment and micronutriments intakes will be assessed with 3 days of dietary records and validated Food Frequency Questionnaire (FFQ) filled in at baseline, month 3 and month 6.",{"measure":118,"description":119,"timeFrame":21},"Indexes of diet quality at baseline, month 3 and month 6 between the nutritional interventions","The Energy-adjusted Dietary Inflammatory Index (E-DII), alternative Healthy Eating Index (AHEI) and Dietary Approches to Stop Hypertension (DASH) will be assessed with a validated Food Frequency Questionnaire (FFQ) filled in at baseline, month 3 and month 6.",{"measure":121,"description":122,"timeFrame":21},"Modification of eating behaviour at baseline, month 3 and month 6 between the nutritional interventions","Modification of eating behaviour will be assessed with the three-factor eating questionnaire 21 (TFEQ-21), filled in at baseline, month 3 and month 6.",{"measure":121,"description":124,"timeFrame":21},"Modification of appetite will be assessed with visual analogue scales to range hunger, fullness and satiety fasting and at the end of meal test, at baseline, month 3 and month 6.",{"measure":126,"description":127,"timeFrame":21},"Modification of gastrointestinal tolerance at baseline, month 3 and month 6 between the nutritional interventions","Modification of gastrointestinal tolerance will be assessed with Bristol Stool Scale at baseline, month 3 and month 6.",{"measure":129,"description":130,"timeFrame":21},"Modification of gastrointestinal symptom at baseline, month 3 and month 6 between the nutritional interventions","Modification of gastrointestinal symptome will be assessed with the Gastrointestinal Symptom Rating Scale (GSRS) at baseline, month 3 and month 6.",{"measure":132,"description":133,"timeFrame":21},"Modification of quality of life at baseline, month 3 and month 6 between the nutritional interventions","Modification of quality of life will be assessed with the General quality of life questionnaire (SF-12) at baseline, month 3 and month 6.",{"measure":135,"description":136,"timeFrame":21},"Modification of impact of weight on quality of life at baseline, month 3 and month 6 between the nutritional interventions","Modification of impact of weight on quality of life will be assessed with the Impact of Weight on quality of Life (IWQOL) questionnaire at baseline, month 3 and month 6.",{"measure":138,"description":139,"timeFrame":21},"Modification of perceived stress at baseline, month 3 and month 6 between the nutritional interventions","Modification of perceived stress will be assessed with the Perceived Stress Scale (PSS) at baseline, month 3 and month 6.",{"measure":141,"description":142,"timeFrame":21},"Modification of self-efficacy at baseline, month 3 and month 6 between the nutritional interventions","Modification of self-efficacy will be assessed with general Stress-efficacy scale (GSES) at baseline, month 3 and month 6.",{"measure":144,"description":145,"timeFrame":21},"Modification of depresion symptoms at baseline, month 3 and month 6 between the nutritional interventions","Modification of depression symptoms will be assessed with Patient Health Questionnaire (PHQ-9) at baseline, month 3 and month 6.",{"measure":147,"description":148,"timeFrame":21},"Physical activity and sedentary behavior at baseline, month 3 and month 6 between the nutritional interventions","Physical activity and sedentary behavior will be assessed by Baecke Physical Activity Questionnaire at baseline, month 3 and month 6",{"measure":150,"description":151,"timeFrame":21},"Sleep duration and quality at baseline, month 3 and month 6 between the nutritional interventions","Sleep duration and quality will be assessed by Pittsburgh Sleep Quality Index (PSQI) at baseline, month 3 and month 6",{"measure":153,"description":154,"timeFrame":155},"Acceptability of the nutritional intervention by the application","Aceptability of the nutritional intervention by the application will be asses with the Client Satisfaction Questionnaire (CSQ-8), at the end of the intervention (month 3)","After 3 month of nutritional intervention",{"measure":157,"description":158,"timeFrame":159},"Integration of the meal plan into daily life","Integration of the meal plan into daily life will be assessed with custom Likert-scale items daily during the intervention","Between 1) baseline and month 3 (after the nutritional intervention)",{"measure":161,"description":162,"timeFrame":163},"Usuability to the nutritional intervention by the application","Usuability and user-friendliness of the mobile application will be assessed using the mHealth App Usability Questionnaire (MAUQ)","At the end of nutritional intervention (month 3)",null,{"allocation":166,"interventionModel":167,"interventionModelDescription":168,"primaryPurpose":169,"observationalModel":164,"timePerspective":164,"maskingInfo":170},"RANDOMIZED","PARALLEL","This is a controlled, randomized, open-label, parallel-group (3-arm), multicenter clinical study","PREVENTION",{"masking":171,"maskingDescription":164,"whoMasked":164},"NONE","Beyond its metabolic consequences, obesity is associated with an increased risk of severe infectious diseases. Indeed, Obesity would be associated with immune remodeling, reduced microbial diversity, gut barrier dysfunction, and increased pro-inflammatory microbial species. These alterations can promote systemic inflammation and metabolic endotoxemia. Moreover, immune checkpoints, including the PD-1\u002FPD-L1 pathway, are important regulators of immune responses and may also contribute to immune dysregulation in obesity.\n\nDiet represents an important modulator of inflammation and immunity. The microbiome and the glycome may further mediate the effects of diet on immune function. Changes in microbial composition and host glycosylation can influence immune signaling and the activity of immune checkpoints.\n\nOverall, the diet-microbiome-glycome axis may represent a key determinant of immune homeostasis in obesity. However, the effects of specific diets and nutrients on immune checkpoints remain insufficiently understood and require further clinical investigation.\n\nIn this clinical study, the investigator teams hypothesize that a nutritional intervention based on personalized dietary recommendations will improve the responses of markers associated with immunity (reduction in CD4+ cells and in the expression of immune checkpoint proteins on T cells, particularly PD-1) in individuals with obesity. The effects on immunity are thought to be mediated by changes in the gut microbiota and potentially by the immunoglycome, which should simultaneously lead to improvements in cardiometabolic health markers. These markers will also be monitored during this study.\n\nThe Nutrimmune clinical study is a controlled, randomized, open-label, parallel-group (3-arm), multicenter.\n\nThe investigators will recruit 168 volunteers (men or women) with moderate obesity (BMI between 30 and 40 kg\u002Fm²), aged 40 to 70 and at immune and metabolic inflammatory risk (hsCRP above 3 mg\u002FL and dietary inflammatory index (E-DII)\\>0).\n\nThe intervention will consist of providing personalized nutritional advice through an app (called TOUVA developed by a private collaborator), which will offer participants appropriate meal plans each week. The nutritional advice will depend on the study arm to which the participant has been randomized.\n\nThree nutritional interventions will be tested in parallel in this study:\n\n* The Balanced-Immunity diet with calorie restriction (BI-CR),\n* The Balanced-Immunity diet without calorie restriction (BI),\n* The standard diet with calorie restriction (STD-CR)\n\nDuring the study, participants will be seen for the first time during a screening visit, followed by three metabolic assessment visits: before starting the intervention, at 3 months into the nutritional intervention, and 3 months after the end of the intervention.\n\nThe primary endpoint will be the change in the percentage of CD4⁺ T cells expressing the immune checkpoint protein (ICP) PD-1 in PBMCs, measured from baseline to 3 months (end of the nutritional intervention).\n\nThe secondary endpoints included : immune and inflammatory phenotypes, microbiome and molecular mechanisms, cardiometabolic and physiological parameters, lifestyle and eating behaviour chang and acceptability, adherence and usability to the nutritional intervention.\n\nThis study would help advance scientific understanding of how dietary and personalized interventions can help improve markers associated with immunity in people with obesity and impaired immunity. In the public health goal to improve the care of people with obesity and impaired immunity.",[174,183,188],{"label":175,"type":176,"description":177,"interventionNames":178},"Balanced-Immunity without caloric restriction","EXPERIMENTAL","The intervention will consist of providing personalized nutritional advice through an app called TOUVA, which will offer participants appropriate meal plans (according to their needs, food preferences and usual food consumption) each week during 3 months. The generated menu is based on food group distribution of the EAT- Lancet diet, except for oily fish, which will be set at two servings per week to ensure adequate omega-3 intake.",[179,180,181,182],"Other: Mixed test meal","Biological: Biological sampling","Behavioral: Questionnaires","Other: Balanced-immunity diet",{"label":184,"type":176,"description":185,"interventionNames":186},"Balanced-Immunity with caloric restriction","Description: The intervention will consist of providing personalized nutritional advice through an app called TOUVA, which will offer participants appropriate meal plans (according to their needs, food preferences and usual food consumption) with a caloric restriction of 500 kcal\u002Fdays (based on the evaluation of total energy requirements), each week during 3 months. The generated menu is based on food group distribution of the EAT- Lancet diet, except for oily fish, which will be set at two servings per week to ensure adequate omega-3 intake.",[179,180,181,187,182],"Other: Caloric restriction",{"label":189,"type":176,"description":190,"interventionNames":191},"Standard diet with caloric restriction","The intervention will consist of providing personalized nutritional advice through an app called TOUVA, which will offer participants appropriate meal plans, according to their needs, food preferences and usual food habits, each week during 3 months. The generated menu has a reduction of 500 kcal\u002Fday (based on the evaluation of total energy requirements). The calories reduction will be proportional across all food groups, except for fruits and vegetables, for which intake should remain unchanged.",[179,180,181,187],[193,198,203,208,212],{"type":194,"name":195,"description":196,"armGroupLabels":197,"otherNames":164},"OTHER","Mixed test meal","A mixed test meal, rich in glucose and lipids will be served to the participant during baseline, 3 months and 6 months visits. The participant will have 10 minutes to eat it, and then blood will be sampled during the 4 hours following ingestion of the meal-test. The test meal must be consumed within 10 minutes in order to ensure standardized ingestion conditions between individuals and to limit biases linked to different ingestion times, which could subsequently alter the kinetics of biomarkers measured following meal ingestion. This will allow us to describe the postprandial excursions in glucose, triglycerides and insulin with indicators of the curve as amplitude, pick or time to return to baseline. These indicators are early markers of cardio-metabolic risk alterations. A biobanking of samples is also performed.",[184,175,189],{"type":199,"name":200,"description":201,"armGroupLabels":202,"otherNames":164},"BIOLOGICAL","Biological sampling","Changes in biological parameters will be assessed based on samples collected before the baseline, 3-month and 6-month visits (maximum 2 days before each visit) for feces, and during visits for blood and adipose tissue.",[184,175,189],{"type":204,"name":205,"description":206,"armGroupLabels":207,"otherNames":164},"BEHAVIORAL","Questionnaires","In order to assess some of the secondary outcomes, participants will be asked to fill in the following questionnaires : 3 24h-recall and validated Food Frequency questionnaire (FFQ), TEFQ, Baecke, Bristol, GSRS, SF12, IWQOL, PSS, PHQ-9, GSES, PSQI, MAUQ and CSQ-8.",[184,175,189],{"type":194,"name":209,"description":210,"armGroupLabels":211,"otherNames":164},"Caloric restriction","Participants will be placed on a calorie-restricted diet with a reduction of 500 kcal\u002Fday (calculated based on total energy requirement) during 3 months. The calories reduction will be proportional across all food groups, except for fruits and vegetables, for which intake will remain unchanged.",[184,189],{"type":194,"name":213,"description":214,"armGroupLabels":215,"otherNames":164},"Balanced-immunity diet","The intervention consists of delivering the diet previously defined as the \"Balanced-Immunity\" diet in the form of meal plan and menus, accessible via TOUVA, a dedicated application during 3 months.",[184,175],[217,222],{"name":218,"role":219,"phone":220,"phoneExt":164,"email":221},"Karine CLEMENT","CONTACT","+33 142177928","karine.clement@inserm.fr",{"name":223,"role":219,"phone":224,"phoneExt":164,"email":225},"Julie-Anne NAZARE","+ 33478863994","julie-anne.nazare@univ-lyon1.fr",[227,248,267,286],{"facility":228,"status":164,"city":229,"state":164,"zip":230,"country":231,"countryCode":232,"cosmosGeoPoint":233,"geoPoint":238,"contacts":239},"Hospices Civils de Lyon et Centre de Recherche en Nutrition Humaine Rhône-Alpes","Lyon","69002","France","FR",{"type":234,"coordinates":235},"Point",[236,237],4.84789,45.74906,{"lat":237,"lon":236},[240,241,245],{"name":223,"role":219,"phone":224,"phoneExt":164,"email":225},{"name":242,"role":219,"phone":243,"phoneExt":164,"email":244},"Louise SECONDA","+33478863994","louise.seconda@univ-lyon1.fr",{"name":246,"role":247,"phone":164,"phoneExt":164,"email":164},"Anne-Laure Castell","PRINCIPAL_INVESTIGATOR",{"facility":249,"status":164,"city":250,"state":164,"zip":251,"country":231,"countryCode":232,"cosmosGeoPoint":252,"geoPoint":256,"contacts":257},"Clinical Investigation Center Pitié-Paris Est and Nutrition dpt. Hôpital Pitié-Salpêtrière, Sorbonne Université, Paris","Paris","75013",{"type":234,"coordinates":253},[254,255],2.3488,48.85341,{"lat":255,"lon":254},[258,262,265],{"name":259,"role":219,"phone":260,"phoneExt":164,"email":261},"Fabienne DELESTRE, PhD","33142177031","fabienne.delestre@aphp.fr",{"name":263,"role":219,"phone":164,"phoneExt":164,"email":264},"Pierre Bel Lassen, MD,PhD","pierre.bellassen@aphp.fr",{"name":266,"role":247,"phone":164,"phoneExt":164,"email":164},"Karine Clément, MD,PhD",{"facility":268,"status":164,"city":269,"state":164,"zip":270,"country":271,"countryCode":272,"cosmosGeoPoint":273,"geoPoint":277,"contacts":278},"University of Hohenheim","Stuttgart","70599","Germany","DE",{"type":234,"coordinates":274},[275,276],9.17702,48.78232,{"lat":276,"lon":275},[279,283,285],{"name":280,"role":219,"phone":281,"phoneExt":164,"email":282},"Benjamin Seethaler","+49 711 459 24102","b.seethaler@uni-hohenheim.de",{"name":284,"role":247,"phone":164,"phoneExt":164,"email":164},"Stephan Bischoff",{"name":280,"role":247,"phone":164,"phoneExt":164,"email":164},{"facility":287,"status":164,"city":288,"state":164,"zip":289,"country":290,"countryCode":291,"cosmosGeoPoint":292,"geoPoint":296,"contacts":297},"Amsterdam UMC","Amsterdam","1105 AZ","Netherlands","NL",{"type":234,"coordinates":293},[294,295],4.88969,52.37403,{"lat":295,"lon":294},[298,302],{"name":299,"role":219,"phone":300,"phoneExt":164,"email":301},"Midas Van den Tweel","+3120 5667050","m.vandentweel@amsterdamumc.nl",{"name":303,"role":247,"phone":164,"phoneExt":164,"email":164},"Max Nieuwdorp",{"type":305,"investigatorFullName":164,"investigatorTitle":164,"investigatorAffiliation":164,"oldNameTitle":164,"oldOrganization":164},"SPONSOR",[307,309,310,312,314,317],{"name":308,"class":194},"Amsterdam UMC, location VUmc",{"name":268,"class":194},{"name":311,"class":194},"University of Bern",{"name":313,"class":194},"Leibniz Institute for Natural Product Research and Infection Biology Hans Knöll Institute",{"name":315,"class":316},"Integrative Phenomics","INDUSTRY",{"name":318,"class":194},"Sorbonne University","100658183","nutrimmune-precision-nutrition-to-improve-immunity-in-individuals-with-obesity-100658183",false,"NCT07850206","NutrImmune: Precision Nutrition to Improve Immunity in Individuals With Obesity","NutrImmune: Precision Nutrition to Improve Immunity in Individuals With Obesity - a Randomized Controlled Study","NutrImmune","Inclusion Criteria:\n\n* 30≤BMI\\\u003C40 kg\u002Fm2\n* Waist circumference ≥80 cm for women and ≥94 cm for men\n* Low-grade inflammatory status, defined as:\n\n  * High-sensitive CRP (hsCRP) ≥ 3 mg\u002FL\n  * Low diet quality: E-DII \\> 0, indicating a pro-inflammatory dietary potential\n* Affiliation with a social security scheme or beneficiary of such a scheme;\n* Effective contraception for women with ability to have children\n* Stable weight for at least 3 months (+\u002F- 5% of total body weight)\n* In the opinion of the investigator, the subject has adequate support to comply with the entire study requirements as described in the protocol (i.e. ability to move to and from trial site, to understand and fill in the questionnaires, use the app; attend the scheduled visits, full understanding of the protocol)\n* Do not follow an exclusive diet (i.e. vegan, vegetarian, or diet without gluten or lactose)\n* Living at maximum 1 hour from clinical trial site\n* Willingness to not change physical activity level for the whole duration of the study.\n* Willingness not to perform any other weight-loss approaches.\n* Agreement to adhere to Lifestyle Considerations throughout study duration\n* For women of childbearing potential, a negative urinary pregnancy test is required\n\nGeneral non-inclusion criteria:\n\n* Persons subject to a safeguard of justice measure\n* Persons without valid health certificate(s) in case of governmental measures in exceptional epidemic situations\n* Persons under legal protection (guardianship, curatorship)\n* Persons unable to use the study applications after a brief introduction or no access to a mobile phone or tablet with Bluetooth and internet access;\n* Persons with devices with previous iOS or Android operating systems that cannot run the applications, given that use of the IPICS-app (TOUVA) is necessary for the study;\n* Persons without a freezer and\u002For reluctant to store biological samples inside;\n* Tobacco (or vaping equivalent) consumption \\> 5 cigarettes per day.\n* Pregnancy or breastfeeding in women of childbearing potential\n* Alcohol consumption exceeding 30g alcohol\u002Fday\n* Claustrophobia for indirect calorimetry.\n* Needle or blood phobia\n\nMedical non-inclusion criteria:\n\n* Usage in past 3 months : Antibiotics, Probiotics, Prebiotics, Systemic corticosteroids, Immunosuppressives\n* Laxative usage in past 2 months\n* PPI (Proton pomp inhibitor) usage in past 2 days\n* Conditions that alter both inflammatory and immune profile and induce biases in results interpretation\n\n  * Uncontrolled thyroid disease, history of musculoskeletal, autoimmune, or neurological disease, as well as abnormal kidney and liver function tests (\\>2 times upper reference range limit)\n  * Presence of active chronic inflammatory disease, autoimmune disease requiring immunomodulatory treatment, known immunodeficiency, active malignancy, active chronic infection, or ongoing immunosuppressive treatment likely to significantly alter the immune parameters under investigation.\n  * Presence of type 2 diabetes or uncontrolled cardiovascular disease (Stable obesity-related comorbidities, including hypertension, dyslipidemia, and stable cardiovascular disease, are not considered exclusion criteria).\n  * Major mental disorders\n  * Severe eating disorders based on detailed medical history, clinical examination and expertise of the investigating physician, trained in nutrition.\n  * The use of medication or physical conditions interfering with the study outcomes, at the discretion of the investigating physician\n  * Infectious episode in the month prior to inclusion\n  * Allergy or intolerance to any of the components of the study devices and products\n  * No contraindications to taking oral nutritional supplements, such as severe swallowing disorders or impaired consciousness, and non-functional digestive tract\n\nExclusion Criteria:\n\n* Health conditions or treatments interfering with the protocol outcomes or procedure, depending on the situation, postponement of visits may be considered at the discretion of the physicians investigators;\n* Withdrawal of consent\n* Appearance of a non-inclusion criterion; depending on the situation, postponement of visits may be considered at the discretion of the investigating physicians;\n* Lost to follow-up","ALL","40 Years","70 Years",{"count":331,"type":332},168,"ESTIMATED","INTERVENTIONAL",[335],"NA","Obesity is a complex health condition defined by the World Health Organization (WHO) as an excess of body weight that may be harmful to health. It leads to other diseases such as type 2 diabetes or cardiovascular diseases, commonly referred to as \"co-morbidities.\" Among these, it is known that obesity increases the risk of developing infectious diseases and of these diseases progressing to severe stages.\n\nDuring the COVID-19 pandemic and the 2009 H1N1 influenza epidemic, a rise in severe infection cases was observed in people with obesity. A part of people with obesity exhibits certain markers on the surface of their immune cells, which are known to cause immunosuppression when present in high numbers, thus increasing the risk of developing infectious diseases.\n\nInvestigator teams found that after bariatric surgery and a calorie-restricted diet for weight loss, patients with obesity can improve the levels of these immunity-related markers. Moreover, the choice of foods consumed contributes to strengthening the immune system and immune functions of individuals, both directly by influencing inflammation and indirectly through the microbiota. However, to date, there are no dietary recommendations specifically designed to help people with obesity improve their immune response.\n\nTherefore, this study aims to compare different dietary recommendations intended to improve immune status, with or without calorie restriction, during 3 months, in individuals with obesity (BMI ≥ 30 kg\u002Fm²) and impaired immunity. Over 6 months (3 months of nutritional intervention and 3 months of follow-up), investigators will collect extensive information through biological samples, measurements and questionnaires to compare the different dietary interventions studied and to understand the mechanisms behind the results obtained.",[338,339,340],"Obesity (BMI>30)","Immune Abnormalities","Low-grade Inflammation",[342,343,344,345,346,347,348],"Obesity","Immune checkpoint expression","balanced diet","caloric restriction","low-grade inflammation","Microbiome","Glyco-immunomic","NOT_YET_RECRUITING","2026-09-29",{"date":352,"type":353},"2026-09-30","ACTUAL",{"date":355,"type":332},"2026-10-01",{"date":357,"type":332},"2029-04",{"name":5,"class":6},4]