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Trial registered on ANZCTR


Registration number
ACTRN12618001044213
Ethics application status
Approved
Date submitted
18/06/2018
Date registered
22/06/2018
Date last updated
13/10/2020
Date data sharing statement initially provided
19/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A study investigating dietary fiber supplementation as an effective therapy to reduce inflammation in chronic obstructive pulmonary disease.
Scientific title
Dietary fiber supplementation and short chain fatty acids as immune regulators in COPD: a potential novel therapy to reduce airway inflammation in COPD.
Secondary ID [1] 295234 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease 308398 0
Condition category
Condition code
Respiratory 307388 307388 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 301570 0
Treatment: Other
Comparator / control treatment
The control group will be a cohort of patients who will receive a placebo compound instead of fiber. The placebo compound will be maltodextrin, manufactured to have the same texture and taste as the fiber supplement.
Control group
Placebo

Outcomes
Primary outcome [1] 306358 0
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).
Timepoint [1] 306358 0
After 28 day supplementation with dietary fiber or placebo
Secondary outcome [1] 348256 0
Altered microbiome - whole genome sequencing of extracted DNA from stool and sputum samples before and after the 28 day intervention
Timepoint [1] 348256 0
After 28 day supplementation with dietary fiber or placebo
Secondary outcome [2] 348257 0
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
Timepoint [2] 348257 0
After 28 day supplementation with dietary fiber or placebo

Eligibility
Key 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.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2019
Actual
28/05/2019
Date of last participant enrolment
Anticipated
31/01/2021
Actual
Date of last data collection
Anticipated
28/02/2021
Actual
Sample size
Target
100
Accrual to date
30
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 11177 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 23018 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 299823 0
Charities/Societies/Foundations
Name [1] 299823 0
The Prince Charles Hospital Foundation
Country [1] 299823 0
Australia
Primary sponsor type
Individual
Name
Annalicia Vaughan
Address
UQ Thoracic Research Center,
Room 2, Level 1, Clinical Sciences Building,
The Prince Charles Hospital
627 Rode Road
Chermside QLD 4032
Country
Australia
Secondary sponsor category [1] 299178 0
Individual
Name [1] 299178 0
Dr Ian Yang
Address [1] 299178 0
Department of Thoracic Medicine,
Level 2 Administration Building
The Prince Charles Hospital
627 Rode Road
Chermside QLD 4032
Country [1] 299178 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300703 0
The Prince Charles Hospital Human Research Ethics Committee [EC00168]
Ethics committee address [1] 300703 0
Ethics committee country [1] 300703 0
Australia
Date submitted for ethics approval [1] 300703 0
14/06/2018
Approval date [1] 300703 0
Ethics approval number [1] 300703 0
Ethics committee name [2] 302695 0
The University of Queensland's Human Research Ethics Committee
Ethics committee address [2] 302695 0
Ethics committee country [2] 302695 0
Australia
Date submitted for ethics approval [2] 302695 0
06/02/2019
Approval date [2] 302695 0
08/02/2019
Ethics approval number [2] 302695 0
2018001673

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84534 0
Dr Annalicia Vaughan
Address 84534 0
UQ Thoracic Research Centre,
Level 1, room 2, clinical sciences building
The Prince Charles Hospital
627 Rode Road
Chermside QLD 4032
Country 84534 0
Australia
Phone 84534 0
+61 7 3139 4110
Fax 84534 0
Email 84534 0
a.vaughan@uq.edu.au
Contact person for public queries
Name 84535 0
Annalicia Vaughan
Address 84535 0
UQ Thoracic Research Centre,
Level 1, room 2, clinical sciences building
The Prince Charles Hospital
627 Rode Road
Chermside QLD 4032
Country 84535 0
Australia
Phone 84535 0
+61 7 3139 4110
Fax 84535 0
Email 84535 0
a.vaughan@uq.edu.au
Contact person for scientific queries
Name 84536 0
Annalicia Vaughan
Address 84536 0
UQ Thoracic Research Centre,
Level 1, room 2, clinical sciences building
The Prince Charles Hospital
627 Rode Road
Chermside QLD 4032
Country 84536 0
Australia
Phone 84536 0
+61 7 3139 4110
Fax 84536 0
Email 84536 0
a.vaughan@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The individual participants data from this trial will contain the medical history of the participants. Therefore will not be available for privacy issues.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.