[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100484516":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":41,"centralContacts":45,"locations":55,"responsibleParty":72,"collaborators":74,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":31,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":31,"enrollmentInfo":86,"targetDuration":31,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":57,"whyStopped":31,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Universite de Moncton","OTHER",[8,16,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Dietary intervention and nutritional supplements (group A)","EXPERIMENTAL","Patients in group A will receive four consultations with a dietitian over eight weeks, in addition to conventional physiotherapy treatments. These patients will receive nutritional counselling and omega-3 (2500mg\u002Fday), vitamin D (2000 IU\u002Fday) and creatine monohydrate (10mg\u002Fday) supplements prescribed by their doctor.",[13,14,15],"Behavioral: Experimental: Dietetic counseling","Dietary Supplement: Active Comparator: Omega-3, vitamin D3 and creatine monohydrate","Behavioral: Other : Physiotherapy treatment",{"label":17,"type":18,"description":19,"interventionNames":20},"Nutritional supplements (group B)","ACTIVE_COMPARATOR","Patients in group B will be prescribed omega-3 (2500mg\u002Fday), vitamin D (2000 IU\u002Fday) and creatine monohydrate (10mg\u002Fday) supplements and receive physiotherapy treatments over eight weeks.",[14,15],{"label":22,"type":6,"description":23,"interventionNames":24},"Physiotherapy treatment (control group)","Patients in the control group will receive physiotherapy treatments over eight weeks.",[15],[26,32,37],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"BEHAVIORAL","Experimental: Dietetic counseling","Patients will receive dietary counselling to increase caloric and nutrient intake, stabilize glycemia, and optimize hydration.",[9],null,{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":31},"DIETARY_SUPPLEMENT","Active Comparator: Omega-3, vitamin D3 and creatine monohydrate","Patients will be prescribed dietary supplements which will be taken daily for 8 weeks, as per the supplement protocol.",[9,17],{"type":27,"name":38,"description":39,"armGroupLabels":40,"otherNames":31},"Other : Physiotherapy treatment","Patients will receive weekly physiotherapy treatment.",[9,17,22],[42],{"name":43,"affiliation":5,"role":44},"Stephanie Ward Chiasson, PhD, RD","PRINCIPAL_INVESTIGATOR",[46,51],{"name":43,"role":47,"phone":48,"phoneExt":49,"email":50},"CONTACT","506-858-4000","4090","stephanie.ward@umoncton.ca",{"name":52,"role":47,"phone":48,"phoneExt":53,"email":54},"Horia-Daniel Iancu, PhD","4999","horia-daniel.iancu@umoncton.ca",[56],{"facility":5,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"RECRUITING","Moncton","New Brunswick","E1A 3E9","Canada","CA",{"type":64,"coordinates":65},"Point",[66,67],-64.7965,46.09454,{"lat":67,"lon":66},[70,71],{"name":43,"role":47,"phone":48,"phoneExt":49,"email":50},{"name":52,"role":47,"phone":48,"phoneExt":53,"email":54},{"type":73,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[75],{"name":76,"class":6},"New Brunswick Health Research Foundation","100484516","evaluation-of-the-impact-of-a-dietary-and-nutritional-intervention-on-persistent-post-concussive-symptoms-100484516",false,"NCT05589064","Evaluation of the Impact of a Dietary and Nutritional Intervention on Persistent Post-concussive Symptoms","Evaluation of the Impact of a Dietary and Nutritional Intervention on the Physical, Cognitive, Behavioural and Emotional Symptoms of Patients With Persistent Post-concussive Symptoms","Inclusion Criteria:\n\n* 16 years or older\n* Must be able to understand English or French\n* Have persistent post-concussive symptoms lasting at least 2 weeks but no longer than 6 months\n\nExclusion Criteria:\n\n* \\\u003C16 years old\n* People who are breastfeeding, pregnant or plan to become pregnant in the next 2 months\n* People with neurological disorders (other than concussion) or a history of moderate or severe brain injury\n* People in an acute phase of an inflammatory bowel disease\n* Any physical condition prohibiting a patient from receiving physiotherapy treatments","ALL","16 Years",{"count":87,"type":88},120,"ESTIMATED","INTERVENTIONAL",[91],"NA","Concussions affect thousands of Canadians every year. Although the effects are usually temporary, 10-15% of adults experience persistent symptoms likely to last several weeks or even months. It is suggested that nutritional interventions should be considered in concussion management because nutrition can act on several mechanisms of brain injury. However, to date, no study has assessed the impact of dietary interventions on the recovery of people with persistent post-concussive symptoms.\n\nThis randomized controlled trial aims to determine the impact of a dietary and nutritional intervention on the physical, cognitive, behavioural and emotional symptoms of patients with persistent post-concussive symptoms in New Brunswick, Canada. Patients will be randomized to one of three groups: 1) dietary treatments and nutritional supplements (experimental group A), 2) nutritional supplements (experimental group B), and 3) physiotherapy treatments (control group). Patients in group A will receive four consultations with a dietitian over eight weeks, in addition to conventional physiotherapy treatments. These patients will receive nutritional counselling and omega-3, vitamin D and creatine supplements. Patients in group B will be prescribed the same supplements as those in group A by their doctor and receive physiotherapy treatments. Finally, patients in the control group will only receive physiotherapy treatments. Patient symptoms will be measured using a questionnaire constructed from tools commonly used in practice. This questionnaire will be completed at the first physiotherapy session and 2, 4 and 8 weeks after the start of the intervention.",[94],"Brain Injury Traumatic Mild",[96,97,98,99,100],"Dietary intervention","Supplements","Omega-3","Vitamin D","Creatine monohydrate","2024-12-09",{"date":103,"type":104},"2024-12-13","ACTUAL",{"date":106,"type":104},"2022-10-01",{"date":108,"type":88},"2025-06",{"name":5,"class":6},1]