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.
Diagnosis of COPD with no exacerbation episodes in the last 3 months
Aged 18 to 75 years
Patient at the Interstitial Lung Diseases Outpatient Clinic of Hospital das Clínicas da UFMG
Ability to perform spirometry
End-stage COPD (GOLD stage 4)
Primary diagnosis of asthma
Interstitial lung disease
Lung transplant recipients
Parallel
Dietary Fiber Supplementation
Dietary supplementDaily oral supplementation of dietary fiber administered for the intervention period alongside standard medical care.
Placebo Control
Dietary supplementDaily oral administration of an isocaloric placebo, identical in appearance, taste, and packaging to the active fiber supplement.
Change in Plasma Fibrinogen Levels
Change in plasma fibrinogen concentrations compared to baseline values at admission.
Change in Serum C-Reactive Protein (CRP) Levels
Change in high-sensitivity C-reactive protein (hs-CRP) serum concentrations evaluated longitudinally from baseline.
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)
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 / greater dyspnea severity. Unit of Measure: score on a scale
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.
Change in Body Mass Index (BMI)
Assessed by bioelectrical impedance analysis (BIA) and calculated as weight in kilograms divided by height in meters squared. Unit of Measure: kg/m\^2 - weight in kilograms, height in meters
Changes in Basal Metabolic Rate (BMR)
Changes in basal metabolic rate evaluated by bioelectrical impedance analysis or indirect calorimetry measured longitudinally across visits.
Change in Fat-Free Mass
Description: Assessed by bioelectrical impedance analysis (BIA). Unit of Measure: weight in kilograms, height in meters
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.
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.
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Júnea Regina Pires Drews
Lead sponsor
Instituto René Rachou (IRR)
Sponsor institution
Instituto René Rachou (IRR)
Collaborator
FAPEMIG - Fundação de Amparo a Pesquisa do Estado de Minas Gerais
Collaborator
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Collaborator
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