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

Browse trials for

• Lung Diseases 3,319
• Pulmonary Disease, Chronic Obstructive 4,252
• Lung Diseases, Obstructive 2,584

Keywords

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

Lung Diseases

3,319 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's planned enrollment of 100 is above the median of 71 across 2,122 interventional studies indexed under Lung Diseases.

Lead sponsor

This is the only study on the registry with Júnea Regina Pires Drews as lead sponsor.

Eligibility criteria

Study arms

• Experimental
  High-Fiber Group

  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 comparator
  Placebo Group

  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 supplementDietary Fiber Supplementation

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

• Dietary supplementPlacebo Control

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

Primary outcomes

1. Change in Plasma Fibrinogen Levels

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

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

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

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

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

3. 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)

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

4. 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

   Time frame: Baseline and Month 6

Secondary outcomes

1. 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.

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

2. 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

   Time frame: Baseline and Month 6

3. Changes in Basal Metabolic Rate (BMR)

   Changes in basal metabolic rate evaluated by bioelectrical impedance analysis or indirect calorimetry measured longitudinally across visits.

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

4. Change in Fat-Free Mass

   Description: Assessed by bioelectrical impedance analysis (BIA). Unit of Measure: weight in kilograms, height in meters

   Time frame: Baseline and Month 6

Other outcomes

1. 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.

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

2. 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.

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

Publications

• • 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 data

Plan to share: 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.