[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609382":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":32,"locations":37,"responsibleParty":56,"collaborators":18,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":67,"maxAge":18,"enrollmentInfo":68,"targetDuration":18,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":40,"whyStopped":18,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Hospital de Clinicas de Porto Alegre","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Nutritional Intervention Group","EXPERIMENTAL","Participants will receive a tailored diet plan made by a registered dietitian, with follow-ups for 3 months. The plan is based on Dietary Reference Intakes and adapted to Parkinson's disease and constipation management guidelines.",[13],"Behavioral: Dietitian-Guided Nutritional Intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","NO_INTERVENTION","Participants will not receive individualized nutritional support during the study period. They will receive the dietary guidance only after the end of the study (3 months).",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Dietitian-Guided Nutritional Intervention","Participants receive a diet plan and nutritional counseling provided by a registered dietitian, based on a standardized protocol aligned with the Dietary Reference Intakes (DRIs) and adapted for the management of Parkinson's disease and constipation. The intervention includes follow-ups with the dietitian over a 3-month period.",[9],[26],"Diet plan",[28],{"name":29,"affiliation":30,"role":31},"Maira Rozenfeld Olchik, PhD","Federal University of Rio Grande do Sul","PRINCIPAL_INVESTIGATOR",[33],{"name":29,"role":34,"phone":35,"phoneExt":18,"email":36},"CONTACT","+55 (51) 33083020","molchik@hcpa.edu.br",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":18,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Hospital de Clínicas de Porto Alegre (HCPA)","RECRUITING","Porto Alegre","Rio Grande do Sul","Brazil","BR",{"type":46,"coordinates":47},"Point",[48,49],-51.23019,-30.03283,{"lat":49,"lon":48},[52,53],{"name":29,"role":34,"phone":35,"phoneExt":18,"email":36},{"name":54,"role":55,"phone":18,"phoneExt":18,"email":18},"Juliana Heitich Brendler, Msc","SUB_INVESTIGATOR",{"type":57,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100609382","nutritional-intervention-for-constipation-symptoms-in-patients-with-parkinsons-disease-100609382",false,"NCT07213856","Nutritional Intervention for Constipation Symptoms in Patients With Parkinson's Disease","Nutritional Intervention for Constipation Symptoms in Patients With Parkinson's Disease: A Randomized Clinical Trial","NUTRI-GUT-PD","Inclusion Criteria:\n\n* Adults with a previous diagnosis of Parkinson's disease\n* On a stable dose of levodopa for at least 3 months\n* Diagnosis of Functional Constipation by the Rome IV protocol\n\nExclusion Criteria:\n\n* Diagnosis of atypical or secondary parkinsonism\n* Hoehn and Yahr stage greater than 2\n* Presence of severe neurological or psychiatric disorders that impair the ability to participate in study procedures\n* Previous diagnosis of dementia\n* Presence of comorbidities such as active cancer, chronic obstructive pulmonary disease (COPD), heart failure, and\u002For chronic kidney disease\n* History of gastrointestinal cancers, inflammatory bowel diseases, or surgeries involving the gastrointestinal tract\n* Constipation secondary to clinical conditions such as hypothyroidism or diabetes mellitus\n* Use of opioids\n* Use of probiotics or antibiotics in the past 8 weeks\n* Continuous use of laxatives in the past 8 weeks\n* Presence of severe dysphagia according to the Functional Oral Intake Scale (FOIS)\n* Individuals receiving enteral or parenteral nutrition\n* Individuals under nutritional follow-up in the past 3 months","ALL","18 Years",{"count":69,"type":70},54,"ESTIMATED","INTERVENTIONAL",[73],"NA","The goal of this clinical trial is to evaluate whether a dietitian-guided nutritional intervention can improve constipation symptoms in people with Parkinson's disease (PD). The main questions it aims to answer are:\n\n* Can a dietitian-guided nutritional intervention increase the number of weekly bowel movements in individuals with PD and functional constipation?\n* Can this intervention positively influence gut microbiota composition, dietary intake, and nutritional status?\n\nResearchers will compare the intervention group to a control group that will receive general dietary guidance only after the study period, to see if the intervention leads to improvements in bowel function and related health outcomes.\n\nParticipants will:\n\n* Follow a diet plan developed by a dietitian, based on dietary reference intakes and tailored to the needs of individuals with PD and constipation\n* Participate in follow-up sessions with the dietitian for 3 months\n* Complete assessments at baseline, midpoint, and end of the intervention to evaluate bowel function, constipation symptoms, gut microbiota, nutritional status, and diet quality",[76,77],"Parkinsons Disease (PD)","Constipation - Functional",[79,80,81,82,83,84,85,86,87],"Microbiota","Diet","Diet, Protein-Restricted","Diet Therapy","Diet, Healthy","Nutrition Therapy","Constipation","Non-Motor Symptoms","Nutritionists","2026-06-15",{"date":90,"type":91},"2026-06-16","ACTUAL",{"date":93,"type":91},"2026-04-02",{"date":95,"type":70},"2029-08",{"name":5,"class":6},1]