[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Dr. Schär AG \u002F SPA\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":76},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100631791","study-of-the-effects-of-food-formulations-containing-antioxidants-prebiotic-fibers-and-oat-beta-glucans-in-individuals-at-risk-of-metabolic-syndrome-100631791",false,"NCT07505277","Study of the Effects of Food Formulations Containing Antioxidants, Prebiotic Fibers, and Oat Beta-glucans in Individuals at Risk of Metabolic Syndrome","Single-arm, Pre-Post Clinical Trial on the Effect of Food Formulations Containing Antioxidants, Prebiotic Fibers, and Oat Beta-glucans in Individuals at Risk of Metabolic Syndrome.","Inclusion Criteria:\n\n* Age between 18 and 60 years\n* Individuals who do not have metabolic syndrome\n* Presence of abdominal circumference \\>94 cm for men or \\>80 cm for women, or a body mass index (BMI) between 25 and 34.9 kg\u002Fm², and at least two of the following parameters:\n* Impaired glucose tolerance (IGT) (≥100 mg\u002FdL), or borderline hypertension (systolic 120-139 mmHg, diastolic 80-90 mmHg), or mild hypercholesterolemia (200-239 mg\u002FdL)\n* Absence of any long-term pharmacological treatment for diabetes, hypertension, dyslipidemia, hyperuricemia, or other chronic conditions\n\nExclusion Criteria:\n\n* Individuals with metabolic syndrome\n* Continuous pharmacological treatments for dysmetabolic conditions\n* BMI \\\u003C18.5 kg\u002Fm² or \\>35 kg\u002Fm²\n* Glycated hemoglobin (HbA1c) \\> 6%\n* Pregnancy","ALL","18 Years","60 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to evaluate whether introducing specific functional foods into the diet of individuals at risk of developing metabolic syndrome leads to improvements in key metabolic and oxidative health parameters.\n\nThe main questions it aims to answer are:\n\nDoes the consumption of these functional foods reduce post-prandial glycemia? Does daily intake of these formulations improve other health indicators such as body weight, body composition, lipid profile, and oxidative metabolomic markers?\n\nThe functional food formulations used in this study include:\n\nA blend of multifunctional ingredients derived from apple and grape by-products Added prebiotic fibers (inulin) Oat β-glucans Omega-3 fatty acids\n\nParticipants will:\n\nConsume the assigned functional food formulations daily Attend regular clinic visits for physiological measurements and blood tests Undergo assessments of body composition, serum lipids, and serum metabolomics\n\nPrimary Study Objective:\n\nVariation in post-prandial glycemia\n\nSecondary Objectives:\n\nReduction in BMI Changes in body composition Changes in serum lipid profile Changes in serum oxidative-related metabolomics",[27],"Metabolic Syndrome",[27,29,30],"Functional foods","Nutritional intervantion","RECRUITING","2026-03-26",{"date":34,"type":35},"2026-04-01","ACTUAL",{"date":37,"type":35},"2026-02-01",{"date":39,"type":21},"2027-06",{"name":41,"class":42},"Dr. Schär AG \u002F SPA","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":60,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"100476836","low-protein-diet-with-low-protein-foods-versus-a-lpd-without-lp-foods-in-patients-with-chronic-kidney-disease-ckd-100476836","NCT05489120","Low-Protein Diet With Low-Protein Foods Versus a LPD Without LP Foods in Patients With Chronic Kidney Disease (CKD)","Randomized Controlled Trial of a Low-Protein Diet (LPD) With Low-Protein (LP) Foods Versus a LPD Without LP Foods in Patients With Chronic Kidney Disease (CKD): Efficacy and Feasibility Study","Inclusion Criteria:\n\n* CKD patient stage 3a-5 (\\\u003C60 ml\u002Fmin\u002F1.73 m² estimated by CKD-EPI formula) and not on dialysis,\n* With a good nutritional status (i.e., absence of malnutrition according to albumin, pre-albumine, BMI and no clinical and paraclinical criteria of malnutrition),\n* Above 1g protein\u002F kg bw (ideal body weight),\n* LPD-naïve patient,\n* Motivated to LPD introduction (ensure during screening phase patient willingness to modify diet habits with counselling accurate follow-up),\n* Available to attend the visits planned by the protocol and able to complete the data collection documents (diet record and self-administered questionnaires),\n* Subject affiliated to a health insurance system or is a beneficiary (art. L.1121-11, Code of Public Health, France),\n* Having given their informed written consent regarding its participation to the protocol.\n\nExclusion Criteria:\n\n* Patient for whom dialysis or transplantation is planned\u002Fexpected within the next 12 months\n* Known allergic reactions to the ingredients present in FLAVIS products (milk, eggs, soy, nut),\n* Uncontrolled Diabetes (HbA1C \\>8.5%),\n* Active cancer (including a 5 years remission period),\n* Psychiatric disorders or inability to follow the protocol,\n* Evidence of any active infectious or uncontrolled inflammatory diseases,\n* Inability to provide blood samples (poor venous capital),\n* Inability to perform correct 24-hours urine collection,\n* Any change of the chronic medication within 1 month before screening,\n* Presence of any significant medical finding or significant history such as uncontrolled systemic diseases that may impact the safety, the interpretation of the results and\u002For the participation of the subject in the study according to the opinion of the investigator,\n* Patient with an active implanted medical device\n* Simultaneous participation in another clinical trial or subject still within the exclusion period of a previous clinical trial.\n* Vulnerable subjects (art. L. 1121-5 à 8 et L. 1122-1-2, Code of Public Health, France) are also excluded from the clinical trial.",{"count":52,"type":21},244,[24],"The KDOQI 2020 - Clinical practice guideline for nutrition in chronic kidney disease (CKD) -recommends protein restriction to reduce the risk of end-stage renal disease\u002Fdeath and improve quality of life, a low protein diet providing 0.55-0.60g dietary protein\u002F kg body weight\u002Fday is recommended. FLAVIS® is a product line of hypoprotein foods specially developed for the treatment of CKD.The use of low-protein foods may facilitate the achievement of nutritional goals in terms of protein intake and help patients to follow a low-protein diet.",[56,57,58,59],"Chronic Kidney Disease Stage 3B","Chronic Kidney Disease stage4","Chronic Kidney Disease Stage 5","Chronic Kidney Disease Stage 3A",[61,62,63,64,65,66],"low-protein diet","low-protein foods","FLAVIS","compliance","effectiveness","safety","2025-01-27",{"date":69,"type":35},"2025-01-29",{"date":71,"type":35},"2022-11-06",{"date":73,"type":21},"2026-03",{"name":41,"class":42},21,""]