[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658020":3},{"organization":4,"outcomesModule":7,"designInfo":88,"detailedDescription":96,"studyPopulation":87,"armGroups":97,"interventions":110,"overallOfficials":87,"centralContacts":116,"locations":87,"responsibleParty":122,"collaborators":87,"id":126,"slug":127,"hasResults":128,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":128,"sex":134,"minAge":135,"maxAge":136,"enrollmentInfo":137,"targetDuration":87,"studyType":140,"phases":141,"briefSummary":143,"conditions":144,"keywords":146,"overallStatus":152,"whyStopped":87,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":87},{"fullName":5,"class":6},"Universidad Francisco de Vitoria","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":87},[9],{"measure":10,"description":11,"timeFrame":12},"Change in LDL Cholesterol (LDL-C)","Change in LDL cholesterol from baseline to week 8, measured in mg\u002FdL. The effect of the intervention will be assessed by comparing the change in LDL cholesterol between the Mediterranean Diet With Legumes group and the Mediterranean Diet With Grass-Fed Organic Meat group.","Baseline to Week 8",[14,17,20,23,26,29,32,35,38,41,44,47,50,53,56,59,62,65,68,71,74,78,81,84],{"measure":15,"description":16,"timeFrame":12},"Change in HDL Cholesterol (HDL-C)","Change in HDL cholesterol from baseline to week 8, measured in mg\u002FdL. The change will be compared between the Mediterranean Diet With Legumes group and the Mediterranean Diet With Grass-Fed Organic Meat group.",{"measure":18,"description":19,"timeFrame":12},"Change in Triglycerides","Change in blood triglyceride concentration from baseline to week 8, measured in mg\u002FdL. The change will be compared between the Mediterranean Diet With Legumes group and the Mediterranean Diet With Grass-Fed Organic Meat group.",{"measure":21,"description":22,"timeFrame":12},"Change in Fasting Blood Glucose","Change in fasting blood glucose from baseline to week 8, measured in mg\u002FdL. Blood samples will be collected after an overnight fast. The change will be compared between the Mediterranean Diet With Legumes group and the Mediterranean Diet With Grass-Fed Organic Meat group.",{"measure":24,"description":25,"timeFrame":12},"Change in Fasting Insulin","Change in fasting insulin concentration from baseline to week 8, measured in appropriate laboratory units. Blood samples will be collected after an overnight fast. The change will be compared between the Mediterranean Diet With Legumes group and the Mediterranean Diet With Grass-Fed Organic Meat group.",{"measure":27,"description":28,"timeFrame":12},"Change in HOMA-IR","Change in the homeostatic model assessment of insulin resistance (HOMA-IR) from baseline to week 8. HOMA-IR will be calculated from fasting glucose and fasting insulin measurements. The change will be compared between the Mediterranean Diet With Legumes group and the Mediterranean Diet With Grass-Fed Organic Meat group.",{"measure":30,"description":31,"timeFrame":12},"Change in High-Sensitivity C-Reactive Protein","Change in high-sensitivity C-reactive protein (hs-CRP) concentration from baseline to week 8, measured in mg\u002FL. The change will be compared between the Mediterranean Diet With Legumes group and the Mediterranean Diet With Grass-Fed Organic Meat group.",{"measure":33,"description":34,"timeFrame":12},"Change in Neutrophil-to-Lymphocyte Ratio","Change in the neutrophil-to-lymphocyte ratio (NLR) from baseline to week 8. NLR will be calculated from neutrophil and lymphocyte counts obtained from the complete blood count. The change will be compared between the Mediterranean Diet With Legumes group and the Mediterranean Diet With Grass-Fed Organic Meat group.",{"measure":36,"description":37,"timeFrame":12},"Change in Body Mass Index","Change in body mass index (BMI) from baseline to week 8, calculated as body weight in kilograms divided by height in meters squared (kg\u002Fm²). The change will be compared between the Mediterranean Diet With Legumes group and the Mediterranean Diet With Grass-Fed Organic Meat group.",{"measure":39,"description":40,"timeFrame":12},"Change in Waist Circumference","Change in waist circumference from baseline to week 8, measured in centimeters. The change will be compared between the Mediterranean Diet With Legumes group and the Mediterranean Diet With Grass-Fed Organic Meat group.",{"measure":42,"description":43,"timeFrame":12},"Change in Systolic Blood Pressure","Change in systolic blood pressure from baseline to week 8, measured in mmHg. Blood pressure will be assessed using the mean of three measurements. The change will be compared between the Mediterranean Diet With Legumes group and the Mediterranean Diet With Grass-Fed Organic Meat group.",{"measure":45,"description":46,"timeFrame":12},"Change in Diastolic Blood Pressure","Change in diastolic blood pressure from baseline to week 8, measured in mmHg. Blood pressure will be assessed using the mean of three measurements. The change will be compared between the Mediterranean Diet With Legumes group and the Mediterranean Diet With Grass-Fed Organic Meat group.",{"measure":48,"description":49,"timeFrame":12},"Change in Total Testosterone","Change in total testosterone concentration from baseline to week 8, measured in appropriate laboratory units. The change will be compared between the Mediterranean Diet With Legumes group and the Mediterranean Diet With Grass-Fed Organic Meat group.",{"measure":51,"description":52,"timeFrame":12},"Change in Serum Cortisol","Change in serum cortisol concentration from baseline to week 8, measured in appropriate laboratory units. The change will be compared between the Mediterranean Diet With Legumes group and the Mediterranean Diet With Grass-Fed Organic Meat group.",{"measure":54,"description":55,"timeFrame":12},"Change in Serum Iron","Change in serum iron concentration from baseline to week 8, measured in appropriate laboratory units. The change will be compared between the Mediterranean Diet With Legumes group and the Mediterranean Diet With Grass-Fed Organic Meat group.",{"measure":57,"description":58,"timeFrame":12},"Change in Serum Ferritin","Change in serum ferritin concentration from baseline to week 8, measured in appropriate laboratory units. The change will be compared between the Mediterranean Diet With Legumes group and the Mediterranean Diet With Grass-Fed Organic Meat group.",{"measure":60,"description":61,"timeFrame":12},"Change in Serum Transferrin","Change in serum transferrin concentration from baseline to week 8, measured in appropriate laboratory units. The change will be compared between the Mediterranean Diet With Legumes group and the Mediterranean Diet With Grass-Fed Organic Meat group.",{"measure":63,"description":64,"timeFrame":12},"Change in Insulin-Like Growth Factor 1","Change in insulin-like growth factor 1 (IGF-1) concentration from baseline to week 8, measured in appropriate laboratory units. The change will be compared between the Mediterranean Diet With Legumes group and the Mediterranean Diet With Grass-Fed Organic Meat group.",{"measure":66,"description":67,"timeFrame":12},"Change in Hemoglobin A1c","Change in hemoglobin A1c (HbA1c) from baseline to week 8, measured as a percentage. The change will be compared between the Mediterranean Diet With Legumes group and the Mediterranean Diet With Grass-Fed Organic Meat group.",{"measure":69,"description":70,"timeFrame":12},"Change in Apolipoprotein B","Change in apolipoprotein B (ApoB) concentration from baseline to week 8, measured in appropriate laboratory units. The change will be compared between the Mediterranean Diet With Legumes group and the Mediterranean Diet With Grass-Fed Organic Meat group.",{"measure":72,"description":73,"timeFrame":12},"Change in Apolipoprotein A-I","Change in apolipoprotein A-I (ApoA-I) concentration from baseline to week 8, measured in appropriate laboratory units. The change will be compared between the Mediterranean Diet With Legumes group and the Mediterranean Diet With Grass-Fed Organic Meat group.",{"measure":75,"description":76,"timeFrame":77},"Lipoprotein(a)","Baseline concentration of lipoprotein(a) \\[Lp(a)\\], measured in appropriate laboratory units before the dietary intervention.","Baseline",{"measure":79,"description":80,"timeFrame":12},"Change in Fat Mass","Change in total fat mass from baseline to week 8, measured in kilograms. Body composition will be assessed at baseline and week 8 using the study's standardized body composition assessment method. The change will be compared between the Mediterranean Diet With Legumes group and the Mediterranean Diet With Grass-Fed Organic Meat group.",{"measure":82,"description":83,"timeFrame":12},"Change in Fat-Free Mass","Change in fat-free mass from baseline to week 8, measured in kilograms. Body composition will be assessed at baseline and week 8 using the study's standardized body composition assessment method. The change will be compared between the Mediterranean Diet With Legumes group and the Mediterranean Diet With Grass-Fed Organic Meat group.",{"measure":85,"description":86,"timeFrame":12},"Change in Body Fat Percentage","Change in body fat percentage from baseline to week 8, expressed as a percentage. Body composition will be assessed at baseline and week 8 using the study's standardized body composition assessment method. The change will be compared between the Mediterranean Diet With Legumes group and the Mediterranean Diet With Grass-Fed Organic Meat group.",null,{"allocation":89,"interventionModel":90,"interventionModelDescription":87,"primaryPurpose":91,"observationalModel":87,"timePerspective":87,"maskingInfo":92},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":93,"maskingDescription":87,"whoMasked":94},"SINGLE",[95],"OUTCOMES_ASSESSOR","The Mediterranean diet is a dietary pattern associated with cardiovascular health and is characterized by a high consumption of plant foods, including vegetables, fruits, whole grains, legumes, nuts, and olive oil. Within this dietary pattern, different combinations of animal- and plant-based protein sources can be used while maintaining the overall characteristics of the diet.\n\nLegumes provide protein, dietary fiber, resistant starch, phytosterols, and phenolic compounds, which may influence lipid and glucose metabolism. Meat provides high-quality protein and highly bioavailable micronutrients, while its nutritional composition may vary according to the production system. In particular, meat from pasture-fed animals may differ in fatty acid composition and other nutritional characteristics from meat produced using conventional intensive systems.\n\nPrevious studies have investigated the effects of replacing meat with legumes on cardiometabolic health. However, much of the available evidence has evaluated conventional meat sources or has compared broader dietary patterns rather than specifically examining the replacement of grass-fed organic meat with legumes while maintaining a Mediterranean dietary pattern. Therefore, the cardiometabolic effects of this specific dietary substitution remain insufficiently characterized.\n\nThe MED-SWAP study is a randomized, controlled, parallel-group clinical trial designed to investigate the effects of replacing grass-fed organic meat with legumes within a Mediterranean diet. Participants will be randomly assigned to one of two dietary interventions for 8 weeks. Both groups will follow a structured Mediterranean dietary pattern, with the main systematic difference being the principal protein source.\n\nThe control group will follow a Mediterranean diet including grass-fed organic meat, consisting of at least four servings per week of a mixture of red and white meat, while limiting legumes as a main dish to a maximum of one serving per week. The intervention group will follow a Mediterranean diet including legumes, with at least four servings per week of legumes such as lentils, chickpeas, beans, or traditional soy, while limiting grass-fed organic meat to a maximum of one serving per week.\n\nThe replacement of meat with legumes will be designed to be isocaloric, with the aim of maintaining comparable total energy intake and the overall macronutrient distribution between groups. The remaining components of the Mediterranean dietary pattern will be structured similarly in both groups. Participants will receive structured menus, standard serving sizes, and food equivalences to facilitate adherence and standardization.\n\nDietary adherence will be monitored throughout the intervention using periodic 3-day dietary records, including one weekend day, 24-hour dietary recalls, and regular contacts with a dietitian-nutritionist. Adherence to the prescribed weekly servings of the main protein source will also be assessed during follow-up visits. Participants who show inadequate adherence will receive individualized dietary reinforcement and will remain in the study whenever possible.\n\nThe study will evaluate whether this specific modification of the protein sources within a Mediterranean dietary pattern is associated with differences in cardiometabolic biomarkers after the 8-week intervention. The primary outcome is the change in LDL cholesterol. Secondary assessments include other lipid parameters, glucose metabolism, inflammatory markers, blood pressure, anthropometric measures, and the neutrophil-to-lymphocyte ratio.\n\nThe study will provide clinical evidence on the effects of modifying the relative contribution of animal and plant protein sources within a Mediterranean dietary pattern, with particular emphasis on the substitution of grass-fed organic meat with legumes. The findings may contribute to a better understanding of how specific food substitutions within an established healthy dietary pattern relate to cardiometabolic health.",[98,104],{"label":99,"type":100,"description":101,"interventionNames":102},"Mediterranean Diet With Grass-Fed Organic Meat","ACTIVE_COMPARATOR","Participants assigned to this arm will follow a structured Mediterranean diet for 8 weeks, including at least four servings per week of grass-fed organic meat, consisting of a mixture of red and white meat. Consumption of legumes as a main dish will be limited to a maximum of one serving per week. The diet will also include the common components of the Mediterranean dietary pattern, including fruits, vegetables, whole grains, nuts, and extra virgin olive oil as the main culinary fat, as well as regular fish consumption. The dietary intervention will be designed to maintain comparable energy intake and overall macronutrient distribution between study groups. Participants will receive structured menus, standard serving sizes, and food equivalences, with dietary adherence monitored throughout the intervention by a dietitian-nutritionist.",[103],"Behavioral: Mediterranean Diet With Grass-Fed Organic Meat",{"label":105,"type":106,"description":107,"interventionNames":108},"Mediterranean Diet With Legumes","EXPERIMENTAL","Participants assigned to this arm will follow a structured Mediterranean diet for 8 weeks, including at least four servings per week of legumes, such as lentils, chickpeas, beans, or traditional soy. Consumption of meat will be limited to a maximum of one serving per week. The diet will also include the common components of the Mediterranean dietary pattern, including fruits, vegetables, whole grains, nuts, and extra virgin olive oil as the main culinary fat, as well as regular fish consumption. The dietary intervention will be designed to maintain comparable energy intake and overall macronutrient distribution between study groups. Participants will receive structured menus, standard serving sizes, and food equivalences, with dietary adherence monitored throughout the intervention by a dietitian-nutritionist.",[109],"Behavioral: Mediterranean Diet With Legumes",[111,114],{"type":112,"name":99,"description":101,"armGroupLabels":113,"otherNames":87},"BEHAVIORAL",[99],{"type":112,"name":105,"description":107,"armGroupLabels":115,"otherNames":87},[105],[117],{"name":118,"role":119,"phone":120,"phoneExt":87,"email":121},"Miguel López Moreno, PhD","CONTACT","+34647892334","miguel.lopez@ufv.es",{"type":123,"investigatorFullName":124,"investigatorTitle":125,"investigatorAffiliation":5,"oldNameTitle":87,"oldOrganization":87},"PRINCIPAL_INVESTIGATOR","Miguel López Moreno","Principal Investigator","100658020","replacing-meat-with-legumes-in-a-mediterranean-diet-100658020",false,"NCT07847996","Replacing Meat With Legumes in a Mediterranean Diet","Effect of Replacing Grass-Fed Organic Meat With Legumes Within a Mediterranean Diet on Cardiometabolic Biomarkers in Healthy Adults: A Randomized Controlled Trial","MED-SWAP","Inclusion Criteria:\n\n* Age 18-65 years.\n* Body mass index (BMI) 18.5-29.9 kg\u002Fm².\n* No previous diagnosis of cardiovascular disease, diabetes mellitus, kidney disease, or chronic inflammatory disease.\n* Habitual consumption of meat and willingness to follow the assigned dietary intervention.\n* No vegetarian or vegan diet during the previous 6 months.\n* Ability to provide written informed consent.\n\nExclusion Criteria:\n\n* Use of lipid-lowering, antihypertensive, or antidiabetic medication.\n* Pregnancy or breastfeeding.\n* Allergy or intolerance to legumes or meat.\n* Significant gastrointestinal disorders.\n* No tobacco use.","ALL","18 Years","65 Years",{"count":138,"type":139},40,"ESTIMATED","INTERVENTIONAL",[142],"NA","This study will investigate whether replacing grass-fed organic meat with legumes within a Mediterranean diet affects cardiometabolic health in healthy adults. Participants will be randomly assigned to follow a Mediterranean diet that includes either grass-fed organic meat or legumes as the main protein source for 8 weeks. The study will compare changes in blood cholesterol, blood glucose, inflammation, blood pressure, and other health measures between the two groups. The main outcome will be the change in LDL cholesterol, a type of cholesterol associated with cardiovascular health. The study will include healthy adults aged 25 to 65 years living in the Community of Madrid, Spain.",[145],"Healthy Adult Participants",[147,148,149,150,151],"legumes","meat","mediterranean diet","plant-based diet","cardiometabolic health","NOT_YET_RECRUITING","2026-09-22",{"date":155,"type":156},"2026-09-29","ACTUAL",{"date":158,"type":139},"2026-10-13",{"date":160,"type":139},"2026-12-14",{"name":5,"class":6}]