[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659789":3},{"organization":4,"outcomesModule":7,"designInfo":44,"detailedDescription":58,"studyPopulation":49,"armGroups":59,"interventions":72,"overallOfficials":82,"centralContacts":90,"locations":96,"responsibleParty":120,"collaborators":124,"id":131,"slug":132,"hasResults":133,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":49,"eligibilityCriteria":137,"healthyVolunteers":133,"sex":138,"minAge":139,"maxAge":140,"enrollmentInfo":141,"targetDuration":49,"studyType":144,"phases":145,"briefSummary":147,"conditions":148,"keywords":152,"overallStatus":159,"whyStopped":49,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":169},{"fullName":5,"class":6},"Instituto René Rachou (IRR)","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":24,"otherOutcomes":37},[9,13,16,20],{"measure":10,"description":11,"timeFrame":12},"Change in Plasma Fibrinogen Levels","Change in plasma fibrinogen concentrations compared to baseline values at admission.","Baseline (outpatient entry\u002Fvisit 1), week 1 (visit 2), week 3 (visit 3), and week 9 (visit 5 \u002F 8 weeks of intervention).",{"measure":14,"description":15,"timeFrame":12},"Change in Serum C-Reactive Protein (CRP) Levels","Change in high-sensitivity C-reactive protein (hs-CRP) serum concentrations evaluated longitudinally from baseline.",{"measure":17,"description":18,"timeFrame":19},"Change in BODE Index Score","Change in the multidimensional BODE index score, which integrates Body Mass Index (BMI), Airflow Obstruction via Forced Expiratory Volume in 1 second (FEV1), Dyspnea via modified Medical Research Council (mMRC) scale, and Exercise Capacity via 6-minute walk distance (6MWD). The BODE index ranges from 0 to 10 points, where higher scores indicate greater disease severity and higher mortality risk. Unit of Measure (Unidade de Medida): score on a scale (ou units on a scale)","Baseline (outpatient entry\u002Fvisit 1) and week 9 (visit 5 \u002F 8 weeks of intervention).",{"measure":21,"description":22,"timeFrame":23},"Change in Dyspnea Score","Assessed using the modified Medical Research Council (mMRC) dyspnea scale. The scale ranges from 0 (no breathlessness except with strenuous exercise) to 4 (too breathless to leave the house). Higher scores indicate worse outcome \u002F greater dyspnea severity. Unit of Measure: score on a scale","Baseline and Month 6",[25,28,31,34],{"measure":26,"description":27,"timeFrame":12},"Changes in Overall Nutritional Status","Evaluation of changes in nutritional status parameters and dietary intake (via food records and food frequency questionnaires) evaluated longitudinally from baseline.",{"measure":29,"description":30,"timeFrame":23},"Change in Body Mass Index (BMI)","Assessed by bioelectrical impedance analysis (BIA) and calculated as weight in kilograms divided by height in meters squared.\n\nUnit of Measure: kg\u002Fm\\^2 - weight in kilograms, height in meters",{"measure":32,"description":33,"timeFrame":12},"Changes in Basal Metabolic Rate (BMR)","Changes in basal metabolic rate evaluated by bioelectrical impedance analysis or indirect calorimetry measured longitudinally across visits.",{"measure":35,"description":36,"timeFrame":23},"Change in Fat-Free Mass","Description: Assessed by bioelectrical impedance analysis (BIA). Unit of Measure: weight in kilograms, height in meters",[38,41],{"measure":39,"description":40,"timeFrame":12},"Changes in Short-Chain Fatty Acids (SCFA) Metabolism","Changes in fecal short-chain fatty acid concentrations (acetate, propionate, and butyrate) evaluated longitudinally from stool samples collected across study visits.",{"measure":42,"description":43,"timeFrame":12},"Changes in Gut Microbiota Composition and Diversity","Evaluation of changes in gut microbial profile, alpha and beta diversity, and relative abundance analyzed via sequencing of fecal samples collected longitudinally across visits.",{"allocation":45,"interventionModel":46,"interventionModelDescription":47,"primaryPurpose":48,"observationalModel":49,"timePerspective":49,"maskingInfo":50},"RANDOMIZED","PARALLEL","Randomized, double-blind, placebo-controlled, parallel-group trial.","TREATMENT",null,{"masking":51,"maskingDescription":52,"whoMasked":53},"QUADRUPLE","Placebo and active fiber supplements are identical in appearance, color, and taste to ensure double-blinding.",[54,55,56,57],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","Patients with COPD will be randomized into two parallel groups: an intervention group receiving dietary fiber supplementation and a control group receiving placebo for a determined intervention period. Primary outcomes will include changes in systemic inflammatory markers (such as plasma cytokines and inflammatory mediators). Secondary outcomes will assess comprehensive nutritional parameters (including dietary intake, body composition, and anthropometric metrics), as well as clinical parameters (lung function, symptom scores, and health-related quality of life). Assessments will be conducted at baseline and at the end of the intervention period to evaluate the therapeutic efficacy and metabolic impact of dietary fiber supplementation.",[60,66],{"label":61,"type":62,"description":63,"interventionNames":64},"High-Fiber Group","EXPERIMENTAL","Participants in this group will receive dietary fiber supplementation in addition to their standard care diet during the intervention period.",[65],"Dietary Supplement: Dietary Fiber Supplementation",{"label":67,"type":68,"description":69,"interventionNames":70},"Placebo Group","PLACEBO_COMPARATOR","Participants in this group will receive an isocaloric placebo supplement matching the appearance and taste of the active intervention.",[71],"Dietary Supplement: Placebo Control",[73,78],{"type":74,"name":75,"description":76,"armGroupLabels":77,"otherNames":49},"DIETARY_SUPPLEMENT","Dietary Fiber Supplementation","Daily oral supplementation of dietary fiber administered for the intervention period alongside standard medical care.",[61],{"type":74,"name":79,"description":80,"armGroupLabels":81,"otherNames":49},"Placebo Control","Daily oral administration of an isocaloric placebo, identical in appearance, taste, and packaging to the active fiber supplement.",[67],[83,87],{"name":84,"affiliation":85,"role":86},"Cristiana C Garcia, Para a Dra. Cristiana Couto Ga","Instituto René Rachou - Fiocruz Minas","PRINCIPAL_INVESTIGATOR",{"name":88,"affiliation":89,"role":86},"Eliana V Mancuzo, PhD","Hospital das Clínicas da UFMG - Ambulatório de Doenças Pulmonares Intersticiais",[91],{"name":92,"role":93,"phone":94,"phoneExt":49,"email":95},"Eliane V Mancuzo, PhD","CONTACT","+55 (31) 3409-9300","elianevmancuzo4@gmail.com",[97],{"facility":89,"status":49,"city":98,"state":99,"zip":100,"country":101,"countryCode":102,"cosmosGeoPoint":103,"geoPoint":108,"contacts":109},"Belo Horizonte","Minas Gerais","30130-100","Brazil","BR",{"type":104,"coordinates":105},"Point",[106,107],-43.93778,-19.92083,{"lat":107,"lon":106},[110,112,115,117,118],{"name":92,"role":93,"phone":111,"phoneExt":49,"email":95},"+55 31 3307-9901",{"name":113,"role":93,"phone":111,"phoneExt":49,"email":114},"Marcelo C Sales, MD","drmarcelochagassales@gmail.com",{"name":116,"role":86,"phone":49,"phoneExt":49,"email":49},"Júnea R Drews, MSc",{"name":92,"role":86,"phone":49,"phoneExt":49,"email":49},{"name":113,"role":119,"phone":49,"phoneExt":49,"email":49},"SUB_INVESTIGATOR",{"type":121,"investigatorFullName":122,"investigatorTitle":123,"investigatorAffiliation":5,"oldNameTitle":49,"oldOrganization":49},"SPONSOR_INVESTIGATOR","Júnea Regina Pires Drews","PhD Student anda Dietitian and Principal Investigator",[125,126,129],{"name":5,"class":6},{"name":127,"class":128},"FAPEMIG - Fundação de Amparo a Pesquisa do Estado de Minas Gerais","UNKNOWN",{"name":130,"class":6},"Conselho Nacional de Desenvolvimento Científico e Tecnológico","100659789","effect-of-dietary-fiber-supplementation-on-systemic-inflammation-and-clinical-parameters-in-copd-a-randomized-double-blind-placebo-controlled-clinical-trial-100659789",false,"NCT07868211","Effect of Dietary Fiber Supplementation on Systemic Inflammation and Clinical Parameters in COPD: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial","Efeito Da Suplementação Dietética De Fibras Sobre Inflamação Sistêmica E Parâmetros Clínicos Na DPOC: Ensaio Clínico Randomizado, Duplo-Cego E Controlado Por Placebo","Inclusion Criteria:\n\n* Inclusion Criteria:\n* Diagnosis of COPD with no exacerbation episodes in the last 3 months\n* Aged 18 to 75 years\n* Patient at the Interstitial Lung Diseases Outpatient Clinic of Hospital das Clínicas da UFMG\n* Ability to perform spirometry\n* Ability to perform the 6-minute walk test (6MWT)\n* Willingness to participate in the study and signed Informed Consent Form (ICF)\n* Ability to read and write\n* Daily dietary fiber intake between 10 and 20 grams\n\nExclusion Criteria:\n\n* End-stage COPD (GOLD stage 4)\n* Primary diagnosis of asthma\n* Interstitial lung disease\n* Lung transplant recipients\n* Severe comorbidities impacting outcomes (severe pancreatic, hepatic, renal, or cardiac disease; inflammatory bowel disease; active neoplasm with prognostic impact; human immunodeficiency virus\u002FAIDS; active pulmonary tuberculosis; multiple sclerosis)\n* Any other condition identified during the screening visit by the investigator or nurse that could interfere with the study or patient safety\n* Diagnosed COPD exacerbation (ECOPD) within the 3 months prior to study start\n* Recent acute respiratory infection\n* Unwillingness or inability to comply with study procedures (e.g., inability to record dietary intake, attend visits, or manage oral supplementation)\n* Pregnant, breastfeeding, or planning to become pregnant\n* Change in smoking habits within the last 6 months\n* Major changes in COPD maintenance therapy within 3 months prior to screening\n* Requirement for other nutritional supplements or parenteral nutrition\n* Daily dietary fiber intake exceeding 28 grams for women or 34 grams for men\n* Use of a short course of oral corticosteroids within 4 weeks prior to Day 1 of the study","ALL","18 Years","75 Years",{"count":142,"type":143},100,"ESTIMATED","INTERVENTIONAL",[146],"NA","Chronic Obstructive Pulmonary Disease (COPD) is characterized by persistent respiratory symptoms and systemic inflammation. Dietary fiber intake has been associated with beneficial effects on gut microbiota composition and systemic inflammatory markers. This study aims to evaluate the effects of dietary fiber supplementation on systemic inflammation and clinical parameters in patients with COPD through a randomized, double-blind, placebo-controlled trial.",[149,150,151],"Pulmonary Disease, Chronic Obstructive (COPD)","Pulmonary Diseases","Pulmonary Diseases, Obstructive",[153,154,155,156,157,158],"Dietary Fiber","Systemic Inflammation","Nutritional Status","Gut Microbiota","Randomized Controlled Trial","Fibras alimentares","NOT_YET_RECRUITING","2026-10-05",{"date":162,"type":163},"2026-10-09","ACTUAL",{"date":165,"type":143},"2026-11",{"date":167,"type":143},"2027-07",{"name":122,"class":6},1]