Effect of Dietary Fiber Supplementation on Systemic Inflammation and Clinical Parameters in COPD: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

NCT07868211 | Not Yet Recruiting

• 4 other identifiers: 01203726400000444U1111-1347-558101203726.4.0000.04448.729.912
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Disease, Chronic Obstructive (COPD); Pulmonary Diseases; Pulmonary Diseases, Obstructive

Keywords

Dietary Fiber; Systemic Inflammation; Nutritional Status; Gut Microbiota; Randomized Controlled Trial; Fibras alimentares

Outcome Measures

Primary Outcomes (4)

• Change in Plasma Fibrinogen Levels

  Change in plasma fibrinogen concentrations compared to baseline values at admission.

  Baseline (outpatient entry/visit 1), week 1 (visit 2), week 3 (visit 3), and week 9 (visit 5 / 8 weeks of intervention).

• Change in Serum C-Reactive Protein (CRP) Levels

  Change in high-sensitivity C-reactive protein (hs-CRP) serum concentrations evaluated longitudinally from baseline.

  Baseline (outpatient entry/visit 1), week 1 (visit 2), week 3 (visit 3), and week 9 (visit 5 / 8 weeks of intervention).

• 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/visit 1) and week 9 (visit 5 / 8 weeks of intervention).

• 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

  Baseline and Month 6

Secondary Outcomes (4)

• Changes in Overall Nutritional Status

  Baseline (outpatient entry/visit 1), week 1 (visit 2), week 3 (visit 3), and week 9 (visit 5 / 8 weeks of intervention).

• Change in Body Mass Index (BMI)

  Baseline and Month 6

• Changes in Basal Metabolic Rate (BMR)

  Baseline (outpatient entry/visit 1), week 1 (visit 2), week 3 (visit 3), and week 9 (visit 5 / 8 weeks of intervention).

• Change in Fat-Free Mass

  Baseline and Month 6

Other Outcomes (2)

• Changes in Short-Chain Fatty Acids (SCFA) Metabolism

  Baseline (outpatient entry/visit 1), week 1 (visit 2), week 3 (visit 3), and week 9 (visit 5 / 8 weeks of intervention).

• Changes in Gut Microbiota Composition and Diversity

  Baseline (outpatient entry/visit 1), week 1 (visit 2), week 3 (visit 3), and week 9 (visit 5 / 8 weeks of intervention).

Study Arms (2)

High-Fiber Group

EXPERIMENTAL

Participants in this group will receive dietary fiber supplementation in addition to their standard care diet during the intervention period.

Dietary Supplement: Dietary Fiber Supplementation

Placebo Group

PLACEBO COMPARATOR

Participants in this group will receive an isocaloric placebo supplement matching the appearance and taste of the active intervention.

Dietary Supplement: Placebo Control

Interventions

Dietary Fiber Supplementation DIETARY_SUPPLEMENT

Daily oral supplementation of dietary fiber administered for the intervention period alongside standard medical care.

High-Fiber Group

Placebo Control DIETARY_SUPPLEMENT

Daily oral administration of an isocaloric placebo, identical in appearance, taste, and packaging to the active fiber supplement.

Placebo Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Ability to perform the 6-minute walk test (6MWT)
• Willingness to participate in the study and signed Informed Consent Form (ICF)
• Ability to read and write
• Daily dietary fiber intake between 10 and 20 grams

You may not qualify if:

• End-stage COPD (GOLD stage 4)
• Primary diagnosis of asthma
• Interstitial lung disease
• Lung transplant recipients
• Severe comorbidities impacting outcomes (severe pancreatic, hepatic, renal, or cardiac disease; inflammatory bowel disease; active neoplasm with prognostic impact; human immunodeficiency virus/AIDS; active pulmonary tuberculosis; multiple sclerosis)
• Any other condition identified during the screening visit by the investigator or nurse that could interfere with the study or patient safety
• Diagnosed COPD exacerbation (ECOPD) within the 3 months prior to study start
• Recent acute respiratory infection
• Unwillingness or inability to comply with study procedures (e.g., inability to record dietary intake, attend visits, or manage oral supplementation)
• Pregnant, breastfeeding, or planning to become pregnant
• Change in smoking habits within the last 6 months
• Major changes in COPD maintenance therapy within 3 months prior to screening
• Requirement for other nutritional supplements or parenteral nutrition
• Daily dietary fiber intake exceeding 28 grams for women or 34 grams for men
• Use of a short course of oral corticosteroids within 4 weeks prior to Day 1 of the study

Sponsors & Collaborators

• Júnea Regina Pires Drews: lead
• 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

Study Sites (1)

Hospital das Clínicas da UFMG - Ambulatório de Doenças Pulmonares Intersticiais

Belo Horizonte, Minas Gerais, 30130-100, Brazil

Location

Related Publications (1)

• • VESTBO, J. et al. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease: GOLD Executive Summary. Am J Respir Crit Care Med, 2013. • MENDES DE ALMEIDA et al. Gut microbiota alterations during respiratory viral infections. Gut Microbes, 2023. • CELLI, B. R. et al. The Body-Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity Index in Chronic Obstructive Pulmonary Disease. N Engl J Med, 2004. • TROMBONE, A. J. et al. Dietary fiber and the gut-lung axis. Nature Communications, 2014.

  BACKGROUND

MeSH Terms

Conditions

Lung Diseases; Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Cristiana C Garcia, Para a Dra. Cristiana Couto Ga

  Instituto René Rachou - Fiocruz Minas

  PRINCIPAL INVESTIGATOR

• Eliana V Mancuzo, PhD

  Hospital das Clínicas da UFMG - Ambulatório de Doenças Pulmonares Intersticiais

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eliane V Mancuzo, PhD

CONTACT

+55 (31) 3409-9300; elianevmancuzo4@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Placebo and active fiber supplements are identical in appearance, color, and taste to ensure double-blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD Student anda Dietitian and Principal Investigator

Model Details: Randomized, double-blind, placebo-controlled, parallel-group trial.

Study Record Dates

• First Submitted: September 30, 2026
• First Posted: October 9, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)