Effect of Dietary Fiber Supplementation on Systemic Inflammation and Clinical Parameters in COPD

Study at a glance

From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

Efeito Da Suplementação Dietética De Fibras Sobre Inflamação Sistêmica E Parâmetros Clínicos Na DPOC: Ensaio Clínico Randomizado, Duplo-Cego E Controlado Por Placebo

ClinicalTrials.gov ID

NCT07868211

Acronym / sponsor ID

01203726400000444

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

Study type

Interventional

Recruitment status

Not yet recruiting

Enrolment

100 participants (estimated)

Lead sponsor

Júnea Regina Pires DrewsOther government

Collaborators

Instituto René Rachou (IRR), FAPEMIG - Fundação de Amparo a Pesquisa do Estado de Minas Gerais, Conselho Nacional de Desenvolvimento Científico e Tecnológico

Study start

Nov 2026 (estimated)

Primary completion

Apr 2027 (estimated)

Study completion

Jul 2027 (estimated)

First posted

9 Oct 2026 (actual)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Randomised

Intervention model

Parallel groups

Masking

Quadruple blind (participant, care provider, investigator, outcomes assessor)

Number of arms

2

Model description

Randomized, double-blind, placebo-controlled, parallel-group trial.

Who may qualify

Ages

18 to 75 years

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Change in Plasma Fibrinogen Levels

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

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

2. Change in Serum C-Reactive Protein (CRP) Levels

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

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

3. Change in BODE Index Score

   Time frame: Baseline (outpatient entry/visit 1) and week 9 (visit 5 / 8 weeks of intervention).

   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)

4. Change in Dyspnea Score

   Time frame: Baseline and Month 6

   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

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
• Background• 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.
• Individual participant dataSharing planned: Yes. The plan for sharing individual participant data has not yet been determined and will depend on future decisions by the ethics committee and institutional policies of the participating centers.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

1 site in 1 country: see every site and its status.