Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000692932
Ethics application status
Approved
Date submitted
23/06/2011
Date registered
7/07/2011
Date last updated
3/02/2020
Date data sharing statement initially provided
6/03/2019
Date results provided
6/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Dietary fat, airway inflammation and bronchodilator response in asthma - Study 1
Scientific title
A randomised controlled, 3-way crossover trial, to examine the effects of a high fat or carbohydrate meal on bronchodilation in adults with stable asthma.
Secondary ID [1] 262263 0
Nil
Universal Trial Number (UTN)
Trial acronym
FAB Study - Study 1
Linked study record
This study is the parent study of the sub-study: ACTRN12612000697886 - A randomised controlled, 4-way crossover trial, to examine the effects of a high saturated fat, omega-6 fat or carbohydrate meal, on bronchodilator response in adults with stable asthma - Study 2

Health condition
Health condition(s) or problem(s) studied:
Asthma 267961 0
Condition category
Condition code
Respiratory 268098 268098 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
At each visit, participants will consume a study meal. The order in which the study meals will be consumed will be randomly allocated. There will be a washout period of 1 week between visits. The study meals are as follows:
1. Fat: 100mL double cream, providing 45g (96%) fat, 29g saturated fat, 1740kJ.
2. Carbohydrate: 104g high energy drink, providing 100% carbohydrate, 1740kJ.
3. Control: 100mL water
Participants will be asked to consume each meal within a 15 minute timeframe.
On arrival baseline lung function will be performed followed by the administration of a short acting B2-agonist (salbutamol 400ug, inhaled via a spacer). The participant will then consume the study meal.
Participants who complete Study 1 may also participate in Study 2.
Intervention code [1] 266656 0
Prevention
Comparator / control treatment
The comparator or control intervention will be 100mL water.
Control group
Placebo

Outcomes
Primary outcome [1] 266843 0
Lung function (FEV1, FVC) assessed using spirometry.
Timepoint [1] 266843 0
Study 1: Baseline, then repeated hourly for the next 6 hours.
Secondary outcome [1] 276691 0
Respiratory impedance using impulse oscillometry.
Timepoint [1] 276691 0
Study 1: Baseline, then repeated hourly for the next 6 hours.

Eligibility
Key inclusion criteria
Stable asthma, non smokers
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
BMI > 35, history of coronary heart disease, diabetes or currently taking lipid lowering drugs or oral corticosteroids.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After screening for eligibility, participants will be assigned to the next available study number. Allocation will be concealed by blinded list held by an independent statistician.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated sequence, using a randomisation table created by computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
This project consists of 2 studies.
Study 1: Effects of macronutrients on bronchodilation (described here)
Study 2: Effects of macronutrients on bronchoprotection (please see study 2 entry)
Participants may consent to participate in 1 or both studies associated with this project.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/07/2011
Actual
2/11/2012
Date of last participant enrolment
Anticipated
Actual
28/07/2014
Date of last data collection
Anticipated
Actual
24/11/2014
Sample size
Target
21
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 267154 0
Self funded/Unfunded
Name [1] 267154 0
Dr Lisa Wood
Country [1] 267154 0
Australia
Primary sponsor type
Hospital
Name
John Hunter Hospital
Address
Lookout Road
New Lambton Heights NSW 2305
Country
Australia
Secondary sponsor category [1] 266227 0
University
Name [1] 266227 0
University of Newcastle
Address [1] 266227 0
University Drive
Callaghan NSW 2308
Country [1] 266227 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269133 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 269133 0
Ethics committee country [1] 269133 0
Australia
Date submitted for ethics approval [1] 269133 0
31/05/2011
Approval date [1] 269133 0
23/06/2011
Ethics approval number [1] 269133 0
11/06/15/4.02

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

Contacts
Principal investigator
Name 32666 0
Prof Lisa Wood
Address 32666 0
Centre for Asthma and Respiratory Diseases
Level 2, West Wing, HMRI Building
Kookaburra Crt
New Lambton Heights, NSW, 2305
AUSTRALIA
Country 32666 0
Australia
Phone 32666 0
+61240420147
Fax 32666 0
+61 2 4042 0046
Email 32666 0
[email protected]
Contact person for public queries
Name 15913 0
Lisa Wood
Address 15913 0
Centre for Asthma and Respiratory Diseases
Level 2, West Wing, HMRI Building
Kookaburra Crt
New Lambton Heights, NSW, 2305
AUSTRALIA
Country 15913 0
Australia
Phone 15913 0
+61240420147
Fax 15913 0
+61 2 40420046
Email 15913 0
[email protected]
Contact person for scientific queries
Name 6841 0
Lisa Wood
Address 6841 0
Centre for Asthma and Respiratory Diseases
Level 2, West Wing, HMRI Building
Kookaburra Crt
New Lambton Heights, NSW, 2305
AUSTRALIA
Country 6841 0
Australia
Phone 6841 0
+61 2 4042 0147
Fax 6841 0
+61 2 4042 0046
Email 6841 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
There is no IPD sharing plan for this trial


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually

Documents added automatically
No additional documents have been identified.