[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625938":3},{"organization":4,"outcomesModule":7,"designInfo":149,"detailedDescription":154,"studyPopulation":154,"armGroups":157,"interventions":168,"overallOfficials":174,"centralContacts":178,"locations":188,"responsibleParty":201,"collaborators":154,"id":203,"slug":154,"hasResults":204,"nctId":205,"briefTitle":206,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":204,"sex":209,"minAge":210,"maxAge":154,"enrollmentInfo":211,"targetDuration":154,"studyType":214,"phases":215,"briefSummary":217,"conditions":218,"keywords":220,"overallStatus":191,"whyStopped":154,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":231},{"fullName":5,"class":6},"Amsterdam University of Applied Sciences","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Feasibility of high plant-based protein intake while simultaneously striving for weight loss and increased protein intake","Three-day food record (plant protein intake as part of total protein intake; g\u002Fday)","At baseline (week 0), in week 13 (halfway), in week 26 (end), and optional follow-up (week 52)",[14,17,20,23],{"measure":15,"description":16,"timeFrame":12},"Feasibility of a weight loss diet during a more plant-based, higher protein intake","Three-day food record on energy (kcal\u002Fday)",{"measure":18,"description":19,"timeFrame":12},"Feasibility of an increased protein intake during a more plant-based protein, weight loss diet","Three-day food record on protein intake (g\u002Fday)",{"measure":21,"description":22,"timeFrame":12},"Effect of 2EAT dietary treatment on weight loss","Body weight in kg (calibrated weighing scales)",{"measure":24,"description":25,"timeFrame":12},"Effect of 2EAT dietary treatment on skeletal muscle mass","Skeletal muscle mass (appendicular lean soft tissue (ALST) in kg) via a DXA-scan",[27,30,33,36,39,43,46,49,52,55,58,61,64,67,70,73,76,79,82,85,88,91,94,97,100,103,106,109,112,115,118,121,124,127,130,133,136,139,142,146],{"measure":28,"description":29,"timeFrame":12},"Effect of 2EAT dietary treatment on physical performance","Short Physical Performance Battery (SPPB). Minimum value: 0; Maximum value 12. Score 0-3: severe limitations; score 4-9: intermediate limitations; score 9-12: normal function.",{"measure":31,"description":32,"timeFrame":12},"Effect of 2EAT dietary treatment on walking distance","400 meter walk test (MWT) in seconds (s)",{"measure":34,"description":35,"timeFrame":12},"Effect of 2EAT dietary treatment on muscle strength","Hand Grip Strength (kg)",{"measure":37,"description":38,"timeFrame":12},"Effect of 2EAT dietary treatment on fat free mass","Fat free mass (in kg) via BODPOD air displacement plethysmograph",{"measure":40,"description":41,"timeFrame":42},"Effect of 2EAT dietary treatment on LDL-cholesterol","Serum LDL-cholesterol (mmol\u002FL)","At baseline (week 0), in week 12 (halfway), in week 26 (end)",{"measure":44,"description":45,"timeFrame":42},"Effect of 2EAT dietary treatment on HDL-cholesterol","Serum HDL-cholesterol (mmol\u002FL)",{"measure":47,"description":48,"timeFrame":42},"Effect of 2EAT dietary treatment on total cholesterol","Serum total cholesterol mmol\u002FL)",{"measure":50,"description":51,"timeFrame":42},"Effect of 2EAT dietary treatment on triglycerides","Serum triglycerides (mmol\u002FL)",{"measure":53,"description":54,"timeFrame":42},"Effect of 2EAT dietary treatment on long-term blood glucose concentration","HbA1c (mmol\u002Fmol)",{"measure":56,"description":57,"timeFrame":42},"Effect of 2EAT dietary treatment on insulin resistance","Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) (values \\>2 indicate insulin resistance)",{"measure":59,"description":60,"timeFrame":42},"Effect of 2EAT dietary treatment on inflammation","High sensitivity CRP (mg\u002FL)",{"measure":62,"description":63,"timeFrame":42},"Effect of 2EAT dietary treatment on vitamin B12 levels","Serum vitamin B12 (pg\u002FmL)",{"measure":65,"description":66,"timeFrame":42},"Effect of 2EAT dietary treatment on body iron stores","Serum ferritin (mcg\u002FL)",{"measure":68,"description":69,"timeFrame":42},"Effect of 2EAT dietary treatment on blood haemoglobin concentration","Blood haemoglobin (mmol\u002FL)",{"measure":71,"description":72,"timeFrame":12},"Effect of 2EAT dietary treatment on vitality","De Nederlandse vitaliteitsmeter (VITA-16 questionnaire). Minimum value: 0; Maximum value 7. Higher scores indicate more vitality.",{"measure":74,"description":75,"timeFrame":12},"Effect of 2EAT dietary treatment on quality of life","Short-Form-36 questionnaire (SF-36) Minimum value: 0; Maximum value 100. Higher scores indicate better health-related quality of life. A score of 0 indicates very poor health-related quality of life, whereas a score of 100 indicates a very good health-related quality of life.",{"measure":77,"description":78,"timeFrame":12},"Effect of 2EAT dietary treatment on carbohydrate intake","Three-day food record on carbohydrate (g\u002Fday)",{"measure":80,"description":81,"timeFrame":12},"Effect of 2EAT dietary treatment on fat intake","Three-day food record on fat (g\u002Fday)",{"measure":83,"description":84,"timeFrame":12},"Effect of 2EAT dietary treatment on saturated fat intake","Three-day food record on saturated fat (g\u002Fday)",{"measure":86,"description":87,"timeFrame":12},"Effect of 2EAT dietary treatment on fiber intake","Three-day food record on fiber (g\u002Fday)",{"measure":89,"description":90,"timeFrame":12},"Effect of 2EAT dietary treatment on calcium intake","Three-day food record on calcium (mg\u002Fday)",{"measure":92,"description":93,"timeFrame":12},"Effect of 2EAT dietary treatment on iron intake","Three-day food record on iron (mg\u002Fday)",{"measure":95,"description":96,"timeFrame":12},"Effect of 2EAT dietary treatment on zinc intake","Three-day food record on zinc (mg\u002Fday)",{"measure":98,"description":99,"timeFrame":12},"Effect of 2EAT dietary treatment on magnesium intake","Three-day food record on magnesium (mg\u002Fday)",{"measure":101,"description":102,"timeFrame":12},"Effect of 2EAT dietary treatment on selenium intake","Three-day food record on selenium (mcg\u002Fday)",{"measure":104,"description":105,"timeFrame":12},"Effect of 2EAT dietary treatment on vitamin B1 intake","Three-day food record on vitamin B1 (mg\u002Fday)",{"measure":107,"description":108,"timeFrame":12},"Effect of 2EAT dietary treatment on vitamin B2 intake","Three-day food record on vitamin B2 (mg\u002Fday)",{"measure":110,"description":111,"timeFrame":12},"Effect of 2EAT dietary treatment on vitamin B6 intake","Three-day food record on vitamin B6 (mcg\u002Fday)",{"measure":113,"description":114,"timeFrame":12},"Effect of 2EAT dietary treatment on folic acid intake","Three-day food record on folic acid (mcg\u002Fday)",{"measure":116,"description":117,"timeFrame":12},"Effect of 2EAT dietary treatment on vitamin B12 intake","Three-day food record on vitamin B12 (mcg\u002Fday)",{"measure":119,"description":120,"timeFrame":12},"Effect of 2EAT dietary treatment on vitamin C intake","Three-day food record on vitamin C (mg\u002Fday)",{"measure":122,"description":123,"timeFrame":12},"Effect of 2EAT dietary treatment on vitamin D intake","Three-day food record on vitamin D (mcg\u002Fday)",{"measure":125,"description":126,"timeFrame":12},"Effect of 2EAT dietary treatment on vitamin E intake","Three-day food record on vitamin E (mg\u002Fday)",{"measure":128,"description":129,"timeFrame":12},"Effect of 2EAT dietary treatment on behavior, dimension \"diffuse emotions\"","Nederlandse Vragenlijst Eetgedrag (NVE) questionnaire on dimension \"diffuse emotions\".\n\nSum questions 3, 8, 10, 28 and divide by 4. Minimal score: 0; maximal score: 5. A score of 5 means the individual has a lot of diffuse emotions, a score of 0 means no diffuse emotions.",{"measure":131,"description":132,"timeFrame":12},"Effect of 2EAT dietary treatment on behavior, dimension \"clearly described emotions\"","Nederlandse Vragenlijst Eetgedrag (NVE) questionnaire on dimension \"clearly described emotions\".\n\nSum questions 1, 5, 13, 16, 20, 23, 25, 30, 32 and divide by 9. Minimal score: 0; maximal score: 5. A score of 5 means the individual has clearly described emotions, a score of 0 means no clearly described emotions.",{"measure":134,"description":135,"timeFrame":12},"Effect of 2EAT dietary treatment on behavior, dimension \"emotional eating\"","Nederlandse Vragenlijst Eetgedrag (NVE) questionnaire dimension \"emotional eating\".\n\nSum questions 1, 3, 5, 8, 10, 13, 16, 20, 23, 25, 28, 30, 32 and divide by 13. Minimal score: 0; maximal score: 5. A score of 5 means the individual is a very emotional eater, a score of 0 means no emotional eating.",{"measure":137,"description":138,"timeFrame":12},"Effect of 2EAT dietary treatment on behavior, dimension \"external eating\"","Nederlandse Vragenlijst Eetgedrag (NVE) questionnaire dimension \"external eating\".\n\nSum questions 2, 6, 9, 12, 15, 18, 21, 24, 27, 33 and divide by 10. Minimal score: 0; maximal score: 5. A score of 5 means the individual is a very external eater, a score of 0 means no external eating.",{"measure":140,"description":141,"timeFrame":12},"Effect of 2EAT dietary treatment on behavior, dimension \"diet-oriented eating\"","Nederlandse Vragenlijst Eetgedrag (NVE) questionnaire dimension \"diet-oriented eating\".\n\nSum questions 4, 7, 11, 14, 17, 19, 22, 26, 29, 31 and divide by 10. Minimal score: 0; maximal score: 5. A score of 5 means the individual is a very diet-oriented eater, a score of 0 means no diet-oriented eating.",{"measure":143,"description":144,"timeFrame":145},"Process evaluation of the 2EAT dietary treatment","Paper-based questionnaire with open questions","At week 26 (end)",{"measure":147,"description":144,"timeFrame":148},"End evaluation of the 2EAT dietary treatment","Optional follow-up (week 52)",{"allocation":150,"interventionModel":151,"interventionModelDescription":152,"primaryPurpose":153,"observationalModel":154,"timePerspective":154,"maskingInfo":155},"RANDOMIZED","PARALLEL","Participants are either assigned to the 1) more plant-based diet group, or the 2) more animal-based diet group.","TREATMENT",null,{"masking":156,"maskingDescription":154,"whoMasked":154},"NONE",[158,164],{"label":159,"type":160,"description":161,"interventionNames":162},"More plant-based diet","EXPERIMENTAL","Participants receive dietary counseling for six months focusing on 1) more plant-based protein (≥60%), 2) higher protein intake (aim 1.2 g\u002Fkg\u002Fd, minimum 0.8 g\u002Fkg\u002Fd) and 3) energy restriction (-500 kcal).",[163],"Behavioral: More plant-based protein intake during weight loss",{"label":165,"type":160,"description":166,"interventionNames":167},"More animal-based diet","Participants receive dietary counseling for six months focusing on 1) more animal-based protein (≥60%), 2) higher protein intake (aim 1.2 g\u002Fkg\u002Fd, minimum 0.8 g\u002Fkg\u002Fd) and 3) energy restriction (-500 kcal).",[163],[169],{"type":170,"name":171,"description":172,"armGroupLabels":173,"otherNames":154},"BEHAVIORAL","More plant-based protein intake during weight loss","Participants receive dietary counseling for six months focusing on 1) energy restriction (-500 kcal), 2) higher protein intake (aim 1.2 g\u002Fkg\u002Fd, minimum 0.8 g\u002Fkg\u002Fd) and according to their assigned diet, either 3) more plant-based protein (≥60%) or more animal-based protein (≥60%).",[165,159],[175],{"name":176,"affiliation":5,"role":177},"Peter Weijs","PRINCIPAL_INVESTIGATOR",[179,184],{"name":180,"role":181,"phone":182,"phoneExt":154,"email":183},"Susanne Wildemast","CONTACT","+31623492734","s.wildemast@hva.nl",{"name":185,"role":181,"phone":186,"phoneExt":154,"email":187},"Sjors Verlaan","+31657442955","s.verlaan@hva.nl",[189],{"facility":190,"status":191,"city":192,"state":193,"zip":194,"country":195,"countryCode":196,"cosmosGeoPoint":154,"geoPoint":154,"contacts":197},"Hogeschool van Amsterdam","RECRUITING","Amsterdam","South Holland","1067SM","Netherlands","NL",[198],{"name":199,"role":181,"phone":200,"phoneExt":154,"email":183},"Wildemast","0641679606",{"type":202,"investigatorFullName":154,"investigatorTitle":154,"investigatorAffiliation":154,"oldNameTitle":154,"oldOrganization":154},"SPONSOR","100625938",false,"NCT07429136","Plant-based Protein-rich Weight Loss Intervention in 55+ Adults With Obesity","2EAT","Inclusion Criteria:\n\n* Aged 55 or older\n* Are obese: have a BMI of \\>30 kg\u002Fm2 or BMI \\>27 kg\u002Fm2 and waist circumference \\>88 cm (women) or \\>102 cm (men)\n* Living independently (not in a health facility)\n* The willingness that the general practitioner will be notified of study participation\n* Written informed consent\n* Willingness to comply with the protocol\n* Consent of the study physician\n\nExclusion Criteria:\n\n* Inability to understand the Dutch language\n* Cognitive impairment (MMSE \\\u003C15)\n* Use of total or partial parenteral nutrition (TPN)\n* Alcohol or drug abuse in the opinion of the investigator\n* Current enrolment in a fixed rehabilitation program or other intervention studies\n* Palliative treatment or a life expectancy of ≤ 3 months\n* Following a vegetarian or vegan (100% plant-based) diet\n* Bariatric surgery\n* Active medical treatment interfering with this intervention (e.g. weight loss medication as Ozempic, cancer patients receiving systemic and immune therapy)\n* Physical disabled: unable to meet the general daily exercise guideline for adults\n* Planned a holiday during the intervention period and is unable to attend group- or individual sessions for \\> 3 weeks\n\nThe health conditions below will be assessed by the study physician. When a condition interferes the dietary treatment or if the diet worsens the participants health it counts as exclusion criteria:\n\n* Diagnosed with unstable coronary heart disease (CHD), decompensated heart failure, uncontrolled hypertension or uncontrolled arrhythmias (e.g. heart failure NYHA \\>3)\n* Diagnosed degenerative neurocognitive disorders\n* Diagnosed with renal failure\n* COPD GOLD \\>3","ALL","55 Years",{"count":212,"type":213},200,"ESTIMATED","INTERVENTIONAL",[216],"NA","The objective of the 2EAT RCT is to investigate whether a shift towards more plant-based (≥60% with a minimum of 50%) protein intake can be achieved in an energy restricted diet for three and six months in older adults (55+) with obesity.\n\nThe 2EAT researchers developed a new dietary counseling plan for six months. This includes four individual consultations, five group meetings and three 24h-recalls. In these six months, participants receive dietary counseling focused on energy restriction (-500 kcal), higher protein intake (aim towards 1.2 g\u002Fkg\u002Fd, minimum of 0.8 g\u002Fkg\u002Fd). Participants are randomly allocated either to the more plant-based diet (≥60%) or the more animal-based diet (≥60%). At the start of the intervention, participants are provided with a workbook and recipe book.\n\nSecondary objectives are to assess the effect after three and six months 2EAT dietary treatment on 1) weight loss and 2) skeletal muscle mass. Exploratory objectives are to assess the effect after three and six months 2EAT dietary treatment on 1) physical health outcomes (muscle mass and physical performance), 2) body composition, 3) metabolic blood parameters, 4) vitality and quality of life, 5) nutritional intake, 6) behavioral changes, 7) evaluate the process of the dietary treatment.",[219],"Obesity",[219,221],"Ageing","2026-02-17",{"date":224,"type":225},"2026-02-24","ACTUAL",{"date":227,"type":225},"2024-08-13",{"date":229,"type":213},"2027-04-01",{"name":5,"class":6},1]