[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100532435":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":26,"locations":25,"responsibleParty":35,"collaborators":25,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":43,"eligibilityCriteria":44,"healthyVolunteers":39,"sex":45,"minAge":46,"maxAge":25,"enrollmentInfo":47,"targetDuration":25,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":59,"whyStopped":25,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":25},{"fullName":5,"class":6},"University Hospital, Grenoble","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Citrulline","EXPERIMENTAL","The experimental product is 100% L-citrulline. Each pod will contain 10 grams of L-citrulline. Ten grams of L-citrulline provide 2.4 g of nitrogen.",[13],"Drug: L-citrulline",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard care","ACTIVE_COMPARATOR","The active comparator is a mixture of the six non-essential amino acids. In order for the active comparator to be iso-nitrogenated compared with the experimental product, it will provide 2.4 g of nitrogen per pod. The active comparator will combine 13.2 % alanine, 19.8 % aspartate, 11.2 % glycine, 17.1 % proline, 15.6 % serine and 23.1 % histidine, for a total of 13 g of amino acids per pod.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","L-citrulline","to take 1 pod a day for 45 days",[9,15],null,[27,32],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":31},"Bruno Degano, MD, PhD","CONTACT","0033476766400","bdegano@chu-grenoble.fr",{"name":33,"role":29,"phone":25,"phoneExt":25,"email":34},"Samarmar Chacaroun, PhD","schacaroun@chu-grenoble.fr",{"type":36,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100532435","phase-3-oral-citrulline-supplementation-in-copd-patients-with-malnutrition-100532435",false,"NCT06212765","Oral Citrulline Supplementation in COPD Patients With Malnutrition","Effects of Oral Citrulline Supplementation on Fat-free Mass in COPD Patients With Malnutrition","CITRUS","Inclusion Criteria:\n\n* Men and women aged 50 and over\n* COPD stage 3 or 4 according to GOLD criteria\n* BMI \\\u003C 20 kg\u002Fm2 if \\\u003C 70 years old or \\\u003C 22 kg\u002Fm2 if ≥ 70 years old\n* Suspicion of sarcopenia marked by a score of 4 or more on the SARC-F questionnaire\n* Absence of severe COPD exacerbation for at least 3 months\n\nExclusion Criteria:\n\n* Main respiratory disease other than COPD\n* Daily long-term use of systemic corticosteroids (\\>6 months per year, whatever the dose)\n* Severe and end-stage renal insufficiency (creatinine clearance \\\u003C30ml\u002Fmin)\n* Patient with severe hypotension, uncontrolled hypertension (at investigator's discretion)\n* Contraindication to L-citrulline intake: VKA and\u002For cancer chemotherapy\n* Osmotic diarrhoea\n* Severe and\u002For uncontrolled progressive pathology likely to be life-threatening\n* Psychiatric pathology (schizophrenia, dementia, severe bipolar\u002Fpsychotic disorders, severe depressive syndrome)\n* Pacemaker or other implanted electronic device","ALL","50 Years",{"count":48,"type":49},60,"ESTIMATED","INTERVENTIONAL",[52],"PHASE3","Chronic obstructive pulmonary disease (COPD) is complicated by malnutrition in 20-70% of cases. In COPD, low fat-free mass is associated with a higher risk of morbidity and mortality. L-citrulline is a non-protein amino acid that has a direct effect on muscle protein synthesis. Oral supplementation with L-citrulline (10 g\u002Fday) in malnourished patients has shown to increase fat-free mass. The effects of L-citrulline supplementation in malnourished COPD patients are unknown.\n\nThe main objective of this prospective, single-centre, randomised, double-blind, placebo-controlled study will be to determine the impact of 45 days of nutritional supplementation with L-citrulline (10 g\u002Fday) on lean body mass (fat-free mass index (in kg.m-2) measured by bioelectrical impedance analysis) in malnourished patients (BMI \\\u003C 20 kg\u002Fm2 if \\\u003C 70 years old or \\\u003C 22 kg\u002Fm2 if ≥ 70 years old) with COPD at stages 3-4 of the GOLD classification.",[55,56],"Chronic Obstructive Pulmonary Disease Severe","Malnutrition",[58,22,56],"COPD","NOT_YET_RECRUITING","2024-01-08",{"date":62,"type":63},"2024-01-19","ACTUAL",{"date":65,"type":49},"2024-01-25",{"date":67,"type":49},"2026-09-25",{"name":5,"class":6}]