None listed
Conditions
Brief summary
Chronic obstructive pulmonary disease (COPD) is characterized by chronic inflammation causing progressive airflow obstruction. Previous research has shown that both the microbiome (bacteria, fungi and viruses) and dietary habits have a strong influence on inflammation in other chronic inflammatory diseases such as inflammatory bowel disease and asthma. Furthermore, dietary fiber supplementation has been shown to reduce inflammation in asthma through the metabolism of fiber by the gut microbiome and increasing the production of short chain fatty acids (SCFAs), which are anti-inflammatory. The main objective of this study is to test dietary fiber supplementation as an intervention to reduce inflammation in COPD, through alteration of the gut and lung microbiome and increased SCFA production.
Interventions
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 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.
Sponsors
Annalicia Vaughan
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
Yes
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.
Exclusion criteria
Exclusion criteria will be use of any continuous prophylactic antibiotics or oral steroids in the past 3 months; current smoking; comorbid lung diseases (asthma, lung cancer, interstitial lung disease, bronchiectasis) that interfere with study outcomes; other comorbidities with established altered microbiome (including IBD, irritable bowel syndrome), and extreme dietary habits significantly impact on gut microbiome composition.
Outcome results
None listed