[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100347711":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":49,"centralContacts":54,"locations":64,"responsibleParty":82,"collaborators":86,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":92,"sex":98,"minAge":99,"maxAge":25,"enrollmentInfo":100,"targetDuration":25,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":67,"whyStopped":25,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Maastricht University Medical Center","OTHER",[8,15,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Group Long-drink","EXPERIMENTAL","83 COPD patients will receive:\n\n* Targeted nutrient supplementation (Long-drink) once daily\n* Counselling once monthly",[13,14],"Dietary Supplement: Targeted nutrient supplementation (Long-drink)","Behavioral: Counselling",{"label":16,"type":17,"description":18,"interventionNames":19},"Group Placebo","PLACEBO_COMPARATOR","83 COPD patients will receive:\n\n* Isocaloric placebo supplement once daily\n* Counselling once monthly",[20,14],"Dietary Supplement: Placebo supplement",{"label":22,"type":23,"description":24,"interventionNames":25},"Healthy control group","NO_INTERVENTION","30 healthy controls will be included for baseline comparison of the microbiome composition. These healthy controls will only perform a subset of baseline measurements and will not be included in the intervention.",null,[27,37,42],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DIETARY_SUPPLEMENT","Targeted nutrient supplementation (Long-drink)","Once daily for at least 12 months",[9],[33,34,35,36],"Nutritional supplementation","Dietary supplement","Nutritional supplement","Food supplement",{"type":28,"name":38,"description":30,"armGroupLabels":39,"otherNames":40},"Placebo supplement",[16],[41],"Non-active supplement",{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"BEHAVIORAL","Counselling","Counselling on healthy lifestyle (in particular physical activity, smoking cessation) and weight management by motivational interviewing",[9,16],[48],"Motivational interviewing",[50],{"name":51,"affiliation":52,"role":53},"Annemie Schols, Prof. dr.","Maastricht UMC+ \u002F NUTRIM, Department of Respiratory Medicine","STUDY_DIRECTOR",[55,60],{"name":56,"role":57,"phone":58,"phoneExt":25,"email":59},"Rosanne Beijers, Dr","CONTACT","+31433882990","r.beijers@maastrichtuniversity.nl",{"name":61,"role":57,"phone":62,"phoneExt":25,"email":63},"Harry Gosker, Dr","+31433884298","h.gosker@maastrichtuniversity.nl",[65],{"facility":66,"status":67,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"Maastricht University Medical Centre+ (MUMC+)","RECRUITING","Maastricht","Limburg","6202 AZ","Netherlands","NL",{"type":74,"coordinates":75},"Point",[76,77],5.68889,50.84833,{"lat":77,"lon":76},[80],{"name":81,"role":57,"phone":25,"phoneExt":25,"email":59},"Rosanne Beijers, PhD",{"type":83,"investigatorFullName":84,"investigatorTitle":85,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Rosanne Beijers","Principal investigator",[87],{"name":88,"class":89},"Nutricia Research","INDUSTRY","100347711","targeted-nutrient-supplement-in-copd-nutrecover-trial-100347711",false,"NCT03807310","Targeted Nutrient Supplement in COPD (NUTRECOVER-trial)","The Effect of Targeted Nutrient Supplementation on Physical Activity and Healthy Related Quality of Life in COPD","NUTRECOVER","Inclusion Criteria COPD Patients:\n\n* COPD patients with moderate to very severe disease stage according to GOLD criteria (i.e. GOLD stage II-IV);\n* Medically stable.\n\nExclusion Criteria COPD Patients:\n\n* Age \\\u003C18 years;\n* Allergy or intolerance to components of the study product;\n* Not willing or not able to quit vitamin D or fatty acid supplement intake;\n* Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements (e.g. leg amputation) or patients suffering from other acute or unstable chronic diseases that will compromise the study outcome (e.g. active cancer requiring treatment);\n* Participation in any other study involving investigational or marketed products concomitantly or within four weeks prior to entry into the study;\n* Patients with terminal illness;\n* Recent hospital admission (\\\u003C4 weeks prior to the start of the study);\n* Temporary oral steroid or antibiotics use due to a COPD exacerbation in the last 4 weeks;\n* Lung malignancy in the previous 5 years;\n* Diagnosis of dementia or neurodegenerative disease (e.g., Alzheimer's disease, Parkinson's disease, Huntington's chorea, frontotemporal dementia) in the medical records;\n* Recent diagnosis of cerebral conditions (\\\u003C1 year e.g. cerebral infarction, hemorrhage, brain tumors, transient ischemic attack) in the medical records;\n* Any medical condition that significantly interferes with digestion and\u002For gastrointestinal function (e.g. short bowel syndrome, inflammatory bowel disease, gastric ulcers, gastritis, (gastro)-enteritis, GI-cancer) as judged by the investigator.\n\nInclusion Criteria Healthy Controls\n\n* Forced expiratory volume in 1 second\u002FForced vital capacity \\> 0.7;\n* Medically stable.\n\nExclusion Criteria Healthy Controls\n\n* Age \\\u003C18 years;\n* Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements (e.g. leg amputation) or patients suffering from other acute or unstable chronic diseases that will compromise the study outcome (e.g. active cancer requiring treatment);\n* Participation in any other study involving investigational or marketed products concomitantly or within four weeks prior to entry into the study;\n* Patients with terminal illness;\n* Recent hospital admission (\\\u003C4 weeks prior to the start of the study);\n* Temporary antibiotics use in the last 4 weeks;\n* Lung malignancy in the previous 5 years;\n* Diagnosis of dementia or neurodegenerative disease (e.g., Alzheimer's disease, Parkinson's disease, Huntington's chorea, frontotemporal dementia) in the medical records;\n* Recent diagnosis of cerebral conditions (\\\u003C1 year e.g. cerebral infarction, hemorrhage, brain tumors, transient ischemic attack) in the medical records;\n* Any medical condition that significantly interferes with digestion and\u002For gastrointestinal function (e.g. short bowel syndrome, inflammatory bowel disease, gastric ulcers, gastritis, (gastro)-enteritis, GI-cancer) as judged by the investigator.\n* Diagnosis of any chronic lung disease.","ALL","18 Years",{"count":101,"type":102},166,"ESTIMATED","INTERVENTIONAL",[105],"NA","The overall objective is to investigate the efficacy of targeted nutrient supplementation on daily physical activity level as well as generic health status in patients with COPD. Additionally the investigators aim to investigate the relative effect of targeted nutrient supplementation on the recovery after hospitalization for a COPD exacerbation. The secondary objective is to investigate the effect of targeted nutrient supplementation on mental health, physical performance, blood markers, patient related outcomes and gut health. Additionally, a secondary objective is to compare the gut microbiome composition of patients with COPD compared to healthy controls.",[108],"Pulmonary Disease, Chronic Obstructive",[110,111,112,113],"COPD","nutrient supplementation","Physical activity","Health related quality of life","2025-01-10",{"date":116,"type":117},"2025-01-14","ACTUAL",{"date":119,"type":117},"2020-02-19",{"date":121,"type":102},"2026-07",{"name":5,"class":6},1]