A study investigating dietary fiber supplementation as an effective therapy to reduce inflammation in chronic obstructive pulmonary disease.

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2018
INTERVENTION: The intervention tested will be a daily dietary fiber supplementation. The patients will receive dietary fiber at 10g/day for 28 days. The patients will be randomly split into two groups where they will receive either the fiber or a placebo compounds within a sachet to be dissolved and consumed daily. The sachet can be dissolved ino any medium, this is at the discretion of the user. The sachet can be consumed at any time in the day, over a single or several sittings, this is at the discretion of the user. The intervention will not be personalized to the individual. Adherence will be checked via a phone call every 7 days. All the patients will continue their prescribed COPD management plan. Healthy participants will be included in this study, however they will not undergo the intervention phase. These participants will participate in a baseline case‐control study in the initiation of this randomized control trial. The baseline study will allow us to effectively compare the gut microbiome and SCFA production of COPD patients against a healthy control group, which is vital for the interpretation of our data in the context of disease and the healthy‐state. CONDITION: Chronic obstructive pulmonary disease PRIMARY OUTCOME: Change in airway inflammation ‐ measuring proinflammatory cytokine levels in sputum samples before and after the 28 day intervention (Interleukin‐8, tumor necrosis factor‐aloha and myeloperoxidase). SECONDARY OUTCOME: Altered microbiome ‐ whole genome sequencing of extracted DNA from stool and sputum samples before and after the 28 day intervention Change in systemic inflammation ‐ measuring full blood cell count, fibrinogen level. C‐reactive protein levels, and inflammatory cytokine levels (tumor necrosis factor‐alpha) in blood samples before and after the 28 day intervention INCLUSION CRITERIA: Patients will have COPD as defined by the GOLD guidelines (chronic airflow limitation that is not fully reversible, with post‐bronchodilator FEV1/FVC <70% and FEV1 <80% predicted). COPD patients will be former smokers of >10 pack‐years, who are recruited during stability (>6 weeks since an exacerbation). Healthy participants will have self‐reported good health, be free of any major medical conditions, and will be never smokers.
Epistemonikos ID: 6cf6f8b291bbb7602908616850ce2d69865f0a12
First added on: Aug 25, 2024