[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658481":3},{"organization":4,"outcomesModule":7,"designInfo":99,"detailedDescription":98,"studyPopulation":98,"armGroups":105,"interventions":116,"overallOfficials":98,"centralContacts":120,"locations":130,"responsibleParty":148,"collaborators":98,"id":150,"slug":151,"hasResults":152,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":152,"sex":158,"minAge":159,"maxAge":160,"enrollmentInfo":161,"targetDuration":98,"studyType":164,"phases":165,"briefSummary":167,"conditions":168,"keywords":172,"overallStatus":133,"whyStopped":98,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":189},{"fullName":5,"class":6},"Institut Investigacio Sanitaria Pere Virgili","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":21,"otherOutcomes":98},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Change from baseline in renal function","Renal function will be estimated using the estimated glomerular filtration rate (eGFR) calculated from serum creatinine (eGFRcr), cystatin-C (eGFRcys), or both (eGFRcr-cys), applying the CKD-Epidemiology Collaboration 2021 equation. Serum creatinine and cystatin C concentrations will be obtained from routine biochemical analyses performed as part of the participants' standard clinical care at the hospital.","Participants will be followed for 6 months, with renal function assessments conducted at baseline, at the 3-month follow up period, and at the end of the 6-month follow-up period.",{"measure":14,"description":15,"timeFrame":16},"Chronic Kidney Disease (CKD) Progression","CKD progression will be assessed using eGFRcr-cys and defined as the first occurrence, during the 6-month intervention period, of any of the following criteria: (i) a decline in eGFRcr-cys of \\>2.5 mL\u002Fmin\u002F1.73 m² from baseline; (ii) a relative decline in eGFRcr-cys of \\>10% from baseline; or (iii) progression to a more advanced stage of kidney function impairment, defined as a transition from G3a to G3b or from G3b to G4 or higher.","CKD progression will be evaluated at the end of the 6-month follow-up period.",{"measure":18,"description":19,"timeFrame":20},"Chronic Kidney Disease (CKD) remission","CKD remission will be assessed using eGFRcr-cys and defined as the first occurrence, during the 6-month intervention period, of any of the following criteria: (i) an increase in eGFRcr-cys of \\>2.5 mL\u002Fmin\u002F1.73 m² from baseline; or (ii) improvement to a less advanced stage of kidney function impairment, defined as a transition from G3b to G3a or from G3a to G2 or lower.","CKD remission will be evaluated at the end of the 6-month follow-up period.",[22,26,30,33,36,39,43,46,49,52,56,59,62,65,68,71,74,77,80,83,86,89,92,95],{"measure":23,"description":24,"timeFrame":25},"Change from baseline in urinary albumin-to-creatinine ratio (UACR)","The urinary albumin-to-creatinine ratio (UACR, mg\u002Fg) will be calculated from urinary albumin and creatinine concentrations measured in first-morning urine samples collected during routine clinical follow-up at the hospital by qualified healthcare personnel, following standard collection and laboratory procedures.","Participants will be followed for 6 months. Measurements will be done at baseline, at the 3-month follow-up period, and at the end of the 6-month follow-up period",{"measure":27,"description":28,"timeFrame":29},"Change from baseline in mineral and bone metabolism markers","Mineral and bone metabolism markers, including potassium, phosphorus, calcium, vitamin D, and parathyroid hormone, will be measured using standardized methods as part of routine fasting blood biochemical analyses.","Participants will be followed for 6 months. Measurements will be done at baseline, at the 3-month follow-up period, and at the end of the 6-month follow-up period.",{"measure":31,"description":32,"timeFrame":29},"Change from baseline in body weight","Body weight will be measured in kilograms (kg) by trained personnel using a calibrated scale, with participants lightly dressed and barefoot.",{"measure":34,"description":35,"timeFrame":29},"Change from baseline in waist circumference","Waist circumference will be measured in centimeters (cm) by trained personnel at the midpoint between the lowest rib and the iliac crest, using a non-stretchable anthropometric tape.",{"measure":37,"description":38,"timeFrame":29},"Change from baseline in Body Mass Index (BMI)","Body weight and height will be used to calculate body mass index (BMI), expressed in kg\u002Fm².",{"measure":40,"description":41,"timeFrame":42},"Change from baseline in body composition","Body composition will be assessed using dual-energy X-ray absorptiometry (DXA), including measures of general adiposity, such as total fat mass in grams and total body fat percentage, and regional adiposity, including trunk, leg, android, and gynoid fat mass in grams.","Participants will be followed for 6 months. Measurements will be done at baseline, and at the end of the 6-month follow-up period.",{"measure":44,"description":45,"timeFrame":42},"Change from baseline in bone mineral density","Bone mineral density will be assessed using dual-energy X-ray absorptiometry (DXA).",{"measure":47,"description":48,"timeFrame":29},"Change from baseline in diet quality","Diet will be assessed using a validated 143-item semiquantitative food frequency questionnaire and the 14-item Mediterranean Diet Adherence Screener (MEDAS). The Mediterranean Diet Adherence Screener score ranges from 0 to 14, with higher scores indicating greater adherence to the Mediterranean diet.",{"measure":50,"description":51,"timeFrame":42},"Change from baseline in physical activity","Physical activity will be assessed using the validated Registre Gironí del Cor (REGICOR) questionnaire, which estimates energy expenditure in total leisure-time physical activity and according to intensity, including light, moderate, and vigorous activity. Physical activity will be expressed in metabolic equivalents (METs), with higher values indicating greater levels of physical activity.",{"measure":53,"description":54,"timeFrame":55},"Change from baseline in medication use affecting glomerular hemodynamics","Medication use will be assessed by administering a general questionnaire by trained personnel, and from the patient's medical history.","Participants will be followed for 6 months. Measurements will be done at baseline, at the 3-month follow up period, and at the end of the 6-month follow-up period.",{"measure":57,"description":58,"timeFrame":42},"Change from baseline in severity of depressive symptoms","Severity of depressive symptoms will be evaluated using the self-administered Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a validated and widely used tool, composed of nine items scored from 0 to 3 (max. 27), which correspond to the DSM-IV criteria and allow depression to be classified as minimal, mild, moderate, moderately severe and severe. Higher scores indicate greater severity of depressive symptoms.",{"measure":60,"description":61,"timeFrame":42},"Change from baseline in severity of anxiety symptoms","Severity of anxiety symptoms will be evaluated using the self-administered Generalized Anxiety Disorder-7 (GAD-7) questionnaire, a brief seven-item scale in which each item is scored from 0 to 3, with a total score from 0 to 21. Higher scores indicate greater severity of anxiety symptoms.",{"measure":63,"description":64,"timeFrame":42},"Change from baseline in quality of life","Quality of life will be assessed using the Kidney Disease Quality of Life-36 (KDQOL-36) questionnaire, a validated instrument for individuals with mild-to-moderate chronic kidney disease that includes the 12-Item Short Form Health Survey (SF-12) and kidney disease-specific subscales: Symptoms and Problems, Effects of Kidney Disease, and Burden of Kidney Disease. Scores for each domain range from 0 to 100, with higher scores indicating better health-related quality of life and a lower perceived burden of disease.",{"measure":66,"description":67,"timeFrame":55},"Change from baseline in fasting glucose","Fasting blood glucose will be measured in mg\u002FdL using standardized methods as part of routine fasting blood biochemical analyses.",{"measure":69,"description":70,"timeFrame":29},"Change from baseline in glycated hemoglobin","Glycated Hemoglobin (%) will be measured using standardized methods as part of routine fasting blood biochemical analyses.",{"measure":72,"description":73,"timeFrame":29},"Changes from baseline in lipid profile","Total cholesterol, LDL-cholesterol, HDL-cholesterol, non-HDL-C, triglycerides and lipoprotein A will be measured in mg\u002FdL, using standardized methods as part of routine fasting blood biochemical analyses.",{"measure":75,"description":76,"timeFrame":29},"Change from baseline in blood pressure","Systolic and diastolic blood pressure (mmHg) will be determined after 5 minutes of rest by trained personnel, in triplicate using a semi-automatic oscillometric blood pressure monitor. The participant will be seated and will use their non-dominant arm.",{"measure":78,"description":79,"timeFrame":55},"Change from baseline in iron status markers","Iron status markers (serum iron, ferritin, transferrin, and transferrin saturation), will be measured using standardized methods as part of routine fasting blood biochemical analyses.",{"measure":81,"description":82,"timeFrame":55},"Change from baseline in hepatic function markers","Hepatic function markers (AST, ALT, and GGT) will be measured using standardized methods as part of routine fasting blood biochemical analyses.",{"measure":84,"description":85,"timeFrame":42},"Change from baseline in lipoprotein profile (particle composition and size)","Lipoprotein profile, including VLDL, LDL, and HDL subfractions composition and size, will be analyzed in fasting blood samples stored at -80 °C in the Biobank using the Advanced Lipoprotein Profile Liposcale® test, based on proton nuclear magnetic resonance (H-NMR) spectroscopy.",{"measure":87,"description":88,"timeFrame":42},"Change from baseline in oxidative markers","Oxidative stress markers, including oxidized low-density lipoprotein (LDL-ox) and malondialdehyde (MDA), will be measured in fasting blood samples stored at -80 °C in the Biobank using commercially available enzyme-linked immunosorbent assays (ELISAs).",{"measure":90,"description":91,"timeFrame":42},"Change from baseline in inflammatory markers","Inflammatory markers, including interleukin-1 beta (IL-1β), interleukin-6 (IL-6), interleukin-8 (IL-8), interleukin-10 (IL-10), tumor necrosis factor-alpha (TNF-α), adiponectin, and leptin, will be measured in fasting blood samples stored at -80 °C in the Biobank using a multiplex immunoassay.",{"measure":93,"description":94,"timeFrame":42},"Change from baseline in endothelial function markers","Endothelial function markers (VCAM-1, ICAM-1, E-selectin, and P-selectin) will be assessed in fasting blood samples stored at -80 °C in the Biobank using a multiplex immunoassay.",{"measure":96,"description":97,"timeFrame":42},"Change from baseline in gut microbiota composition","Gut microbiota composition will be assessed by shotgun metagenomic sequencing following DNA extraction, with subsequent taxonomic characterization of microbial diversity and functional potential using established bioinformatics pipelines. Participants will receive instructions and a collection kit for stool sample collection. Samples will be submitted frozen, processed, aliquoted, and stored at -80 °C in the Biobank until analysis.",null,{"allocation":100,"interventionModel":101,"interventionModelDescription":98,"primaryPurpose":102,"observationalModel":98,"timePerspective":98,"maskingInfo":103},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":104,"maskingDescription":98,"whoMasked":98},"NONE",[106,112],{"label":107,"type":108,"description":109,"interventionNames":110},"Daily Walnut Consumption","EXPERIMENTAL","Participants in the intervention group will consume 30 g\u002Fday of raw walnuts in addition to receiving a Mediterranean diet (MedDiet)-based dietary counseling program. To ensure and facilitate adherence, participants will receive two educational leaflets: one providing practical guidance on following a MedDiet and another containing MedDiet-compatible recipes incorporating walnuts. They will also receive written guidance on optimizing phosphorus and potassium intake within a Mediterranean dietary pattern, including information on food sources, hidden additives, and cooking techniques that may reduce mineral content.\n\nWalnuts will be provided free of charge and distributed at baseline and at each follow-up visit.",[111],"Other: Daily Walnut Consumption",{"label":113,"type":114,"description":115,"interventionNames":98},"Control: MedDiet-based dietary counseling","NO_INTERVENTION","Participants in the control group will receive the same MedDiet-based dietary counseling without walnut supplementation.",[117],{"type":6,"name":107,"description":118,"armGroupLabels":119,"otherNames":98},"Participants in the intervention group will consume 30 g\u002Fday of raw walnuts for 6 months in addition to receiving a Mediterranean diet (MedDiet)-based dietary counseling program.",[107],[121,126],{"name":122,"role":123,"phone":124,"phoneExt":98,"email":125},"Andrés Díaz López, PhD","CONTACT","+34 977759372","andres.diaz@urv.cat",{"name":127,"role":123,"phone":128,"phoneExt":98,"email":129},"Verónica Ruíz García, PhD","+34 677150430","vruiz.hj23.ics@gencat.cat",[131],{"facility":132,"status":133,"city":134,"state":135,"zip":136,"country":137,"countryCode":138,"cosmosGeoPoint":139,"geoPoint":144,"contacts":145},"Unit for Public Health and Nutritional Epidemiology, Faculty of Medicine and Health Sciences, Universitat Rovira i Virgili","RECRUITING","Reus","Tarragona","43201","Spain","ES",{"type":140,"coordinates":141},"Point",[142,143],1.10687,41.15612,{"lat":143,"lon":142},[146,147],{"name":122,"role":123,"phone":124,"phoneExt":98,"email":125},{"name":127,"role":123,"phone":128,"phoneExt":98,"email":129},{"type":149,"investigatorFullName":98,"investigatorTitle":98,"investigatorAffiliation":98,"oldNameTitle":98,"oldOrganization":98},"SPONSOR","100658481","walnuts-for-cardiorenal-protection-in-adults-with-chronic-kidney-disease-100658481",false,"NCT07851454","Walnuts for Cardiorenal Protection in Adults With Chronic Kidney Disease","Impact of Walnut Consumption on Renal Function and Classical and Emerging Biomarkers of Cardiovascular Risk in Adults With Chronic Kidney Disease: The NutReCard Study","NutReCard","Inclusion Criteria:\n\n* Men and women with stable mild to moderate chronic kidney disease \\[CKD\\] (stage G3a-b (estimated glomerular filtration rate \\[eGFR\\] 30-\\\u003C60mL\u002Fmin\u002F1.73 m²) and albuminuria stages A1-3 (UACR from \\\u003C 30mg\u002Fg to ≥ 300 mg\u002Fg))\n* 45-75 years old at screening\n* Overweight\u002Fobesity (Body Mass Index \\[BMI\\] ≥25 and ≤40 kg\u002Fm²)\n* Meet at least one of the following conditions:\n\n  (i) Systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, or use of antihypertensive agents (ii) Triglycerides ≥150 mg\u002FdL, LDL cholesterol ≥160 mg\u002FdL, HDL cholesterol ≤40 mg\u002FdL in men or ≤50 mg\u002FdL in women, or use of lipid-modifying medication (iii) Prediabetes or type 2 diabetes according to the American Diabetes Association (ADA) Standards, or use of glucose-lowering medication.\n\nExclusion Criteria:\n\n* Inability to give written informed consent\n* CKD caused by polycystic kidney disease, chronic pyelonephritis, and renal dysplasia\n* CKD on renal replacement therapy (hemodialysis, peritoneal dialysis, and kidney transplant recipients)\n* Acute exacerbation of CKD, whether due to extrarenal causes (decompensated heart failure, infectious disease or sepsis, surgical intervention) or due to an outbreak of underlying glomerular or systemic renal pathology, with changes in treatment in the last 2 months.\n* Nut allergy\n* Alcoholism (\\>50 g\u002Fday) or drug abuse\n* Treatment with immunosuppressant drugs or cytotoxic agents\n* Any other medical condition that interferes with the completion of the protocol (pregnancy\u002Fbreastfeeding, history of inflammatory bowel disease, liver failure, cancer or active neoplasms, psychiatric problems)\n* Institutionalization of the participant.","ALL","45 Years","75 Years",{"count":162,"type":163},150,"ESTIMATED","INTERVENTIONAL",[166],"NA","To date, no rigorous randomized controlled trials have demonstrated a protective effect of daily moderate walnut consumption on kidney function or chronic kidney disease (CKD) progression in individuals with CKD.\n\nObjective: To determine the effect of walnut supplementation (30 g\u002Fday of raw walnuts) within a Mediterranean diet (MedDiet) based dietary counseling program, compared with the same MedDiet counseling program without walnut supplementation, on kidney function, CKD progression and regression, and classical and emerging cardiovascular risk markers in individuals with CKD. Secondary objectives focus on assessing whether regular walnut consumption as a healthy snack has a positive impact on inflammation, oxidative stress, endothelial dysfunction, and intestinal dysbiosis, conditions intrinsically linked to CKD that play a pathophysiological role in promoting\u002Fexacerbating its progression and the development of comorbidities in this vulnerable group of subjects.\n\nMethodology: A 6-month randomized controlled trial will be conducted in 150 men and women aged 45 to 75 years with stable mild to moderate CKD (stage G3a-b), overweight or obesity, and high cardiometabolic risk. The study will compare the effect of two interventions assessed at 3 and 6 months on the following outcomes:\n\n1. Primary outcomes: a) changes in kidney function assessed by the Estimated Glomerular Filtration Rate based on creatinine and cystatin C (eGFRcr-cys); b) CKD progression; and c) CKD remission\n2. Secondary outcomes: a) urinary albumin-to-creatinine ratio (UACR); b) mineral and bone metabolism parameters, c) anthropometry and body composition (Dual-Energy X-ray Absorptiometry, DXA); d) bone mineral density (DXA); e) diet quality; f) physical activity; g) medication use; h) psychological well-being; i) quality of life; j) classic cardiovascular risk markers; k) iron status and hepatic function; l) inflammation, endothelial function, and oxidation markers; m) gut microbiota",[169,170,171],"CKD - Chronic Kidney Disease","Renal Function","Cardiovascular Biomarkers",[173,174,175,176,177,178,179],"Nuts","Walnut","Mediterranean diet","Kidney function","Chronic kidney disease","Inflammation","Intestinal dysbiosis","2026-09-24",{"date":182,"type":183},"2026-10-01","ACTUAL",{"date":185,"type":183},"2026-08-04",{"date":187,"type":163},"2028-06",{"name":5,"class":6},1]