Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000236493
Ethics application status
Approved
Date submitted
26/04/2007
Date registered
3/05/2007
Date last updated
6/03/2019
Date data sharing statement initially provided
6/03/2019
Date results information initially provided
6/03/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
High energy diets and airway inflammation
Scientific title
Using high energy diets to induce inflammation in asthma
Secondary ID [1] 287954 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
FAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 1773 0
Healthy Controls 296832 0
Condition category
Condition code
Respiratory 1859 1859 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The second phase of the study intervention is a 4hour dietary challenge model instead of the 24hr dietary challenge model previously identified.The study will be a randomised ,controlled, single blinded, parallel trial with 3 groups, each using a 4 hour dietary challenge of an equicaloric meal of varying macro nutrient composition.In each group the participants will receive one meal consisting of 800 calories
Intervention code [1] 1725 0
Other interventions
Comparator / control treatment
Control = Low energy diet (75% Recommended Daily Energy Intake).
Control group
Dose comparison

Outcomes
Primary outcome [1] 2638 0
Plasma IL-6, assessed by Enzyme Immuno Assay
Timepoint [1] 2638 0
At 0, 4 and 24 hours
Secondary outcome [1] 4480 0
Sputum neutrophils
Timepoint [1] 4480 0
Assessed by differential cell count at 0,4 and 24 hours

Eligibility
Key inclusion criteria
Adults with asthma and healthy controls
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Abnormal blood pressure- Abnormal heart rhythms- Abnormal blood cholesterol levels- Obesity (Body Mass Index (BMI) >30)- History of coronary heart disease, diabetes or familial lipid disorders- Use of blood pressure or 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, subjects will be assigned to the next available study number which has previously been randomly allocated to the Intervention or Control group. Allocation will be concealed until the clinical research officer contacts the holder of the allocation schedule at a central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated sequence
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/05/2007
Actual
8/02/2007
Date of last participant enrolment
Anticipated
Actual
2/02/2010
Date of last data collection
Anticipated
Actual
18/03/2010
Sample size
Target
34
Accrual to date
Final
129
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 4698 0
John Hunter Hospital Royal Newcastle Centre - New Lambton
Recruitment postcode(s) [1] 12270 0
2305 - New Lambton Heights

Funding & Sponsors
Funding source category [1] 2008 0
Charities/Societies/Foundations
Name [1] 2008 0
John Hunter Hospital Charitable Trust Fund
Country [1] 2008 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Health Service
Address
Lookout Rd, New Lambton Heights, 2305, NSW, Australia
Country
Australia
Secondary sponsor category [1] 1819 0
None
Name [1] 1819 0
none
Address [1] 1819 0
Country [1] 1819 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3731 0
John Hunter Hospital-University of Newcastle
Ethics committee address [1] 3731 0
Ethics committee country [1] 3731 0
Australia
Date submitted for ethics approval [1] 3731 0
Approval date [1] 3731 0
13/12/2007
Ethics approval number [1] 3731 0
06/10/25/5.03

Summary
Brief summary
This study examines the effect of a high energy intake on inflammation in asthma. We hypothesise that a high energy diet will cause an increase in both systemic and airway inflammation. Subjects are randomly assigned to a high energy or low energy diet for 24 hours. Systemic and airway inflammation will be assessed at 0, 4 and 24 hours.
Trial website
Trial related presentations / publications
1. Wood LG, Garg ML, Gibson PG. A high-fat challenge increases airway inflammation and impairs bronchodilator recovery in asthma. J Allergy Clin Immunol 2011; 127(5): 1133-40.
2. Wood LG, Garg ML, Wood A, Smart J, Gibson PG. A High Fat, High Energy Food Challenge Induces an Exaggerated Inflammatory Response in Asthma. Am J Respir Crit Care Med 2009; 179.
3. Haghi M, Chrzanowski W, Traini D, Wood LG, Oliver B, Young PM A ‘soft spot’ for drug transport: modulation of cell stiffness using fatty acids and its impact on drug transport in a lung model. Journal of Materials Chemistry B 3: 258/3-89 (2015).
4. De Pedro M, Wood L, Oliver B. THE EFFECT OF FATTY ACIDS ON B2-AGONIST RESPONSE IN HUMAN AIRWAY SMOOTH MUSCLE CELLS. Respirology 2014; 19: 64
5. Haghi M, Chrzanowski W, Traini D, Wood L, Oliver B, Young P. THE ROLE OF DIETARY FATTY ACIDS IN TRANSPORT OF SALBUTAMOL ACROSS CALU-3 EPITHELIA. Respirology 2014; 19: 38
Public notes

Contacts
Principal investigator
Name 27828 0
Prof Lisa Wood
Address 27828 0
Centre for Asthma and Respiratory Diseases
Level 2, West Wing, HMRI Building
Kookaburra Crt
New Lambton Heights, NSW, 2305
Country 27828 0
Australia
Phone 27828 0
+61 2 40420147
Fax 27828 0
+61 2 40420046
Email 27828 0
[email protected]
Contact person for public queries
Name 10914 0
Dr Bronwyn Berthon
Address 10914 0
Centre for Asthma and Respiratory Diseases
Level 2, West Wing, HMRI Building
Kookaburra Crt
New Lambton Heights, NSW, 2305
Country 10914 0
Australia
Phone 10914 0
+61 2 40420116
Fax 10914 0
+61 2 40420046
Email 10914 0
[email protected]
Contact person for scientific queries
Name 1842 0
Prof Dr Lisa Wood
Address 1842 0
Centre for Asthma and Respiratory Diseases
Level 2, West Wing, HMRI Building
Kookaburra Crt
New Lambton Heights, NSW, 2305
Country 1842 0
Australia
Phone 1842 0
+61 2 40420147
Fax 1842 0
+61 2 40420046
Email 1842 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 in place 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
SourceTitleYear of PublicationDOI
EmbaseSoluble fibre meal challenge reduces airway inflammation and expression of GPR43 and GPR41 in asthma.2017https://dx.doi.org/10.3390/nu9010057
N.B. These documents automatically identified may not have been verified by the study sponsor.