Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000697886
Ethics application status
Approved
Date submitted
14/06/2012
Date registered
29/06/2012
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
Prospectively registered

Titles & IDs
Public title
Dietary fat, airway inflammation and bronchodilator response in asthma - Study 2
Scientific title
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
Secondary ID [1] 280554 0
Nil
Universal Trial Number (UTN)
Trial acronym
FAB Study - Study 2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 286552 0
Condition category
Condition code
Respiratory 286820 286820 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will attend four visits. At each visit, participants will consume a study meal at 0 hours and a study meal or water at 2 hours. The order in which these meals will be consumed will be randomly allocated. There will be a washout period of at least 1 week between visits. The four study groups are as follows:
1. Control Group
0 hours - 200g plain mashed potato (720kJ, 0.2g fat, 40g carbohydrate)
2 hours - 250mL plain water (0kJ)
2. Carbohydrate Group
0 hours - 200g plain mashed potato (720kJ, 0.2g fat, 40g carbohydrate)
2 hours - Participants can choose their preference of either: marshmallows (138g) (1918kJ, 0g fat, 109g carbohydrate) OR white jelly beans (114g) (1858kJ, <1g fat, 109g carbohydrate) OR marshmallows (69g) and white jelly beans (57g) (1888kJ, <1g fat, 109g carbohydrate).
3. Saturated Fat Group:
0 hours - 200g mashed potato (720kJ, 0.2g fat, 40g carbohydrate) mixed with 75g double cream and 14g unsalted butter (1940kJ, 50g fat, 3.4g carbohydrate)
2 hours - 250mL plain water (0kJ)
4. Omega-6 Fat Group:
0 hours - 200g mashed potato (720kJ, 0.2g fat, 40g carbohydrate) mixed with 50g sunflower oil (1850kJ, 50g fat, 0g carbohydrate
2 hours - 250mL plain water (0kJ)
Participants will be asked to consume each meal within a 15 minute timeframe.

On arrival, participants will undergo exhaled nitric oxide (eNO) measurement, blood pressure/pulse wave velocity measurement, and a fasting venous blood sample will be collected. Baseline lung function will be measured. A hypertonic saline challenge/sputum induction will be performed for a standardised 15.5 minutes nebuliser time. All participants will be administered with a short acting B2-agonist (salbutamol 200ug, inhaled via a spacer) either when they exhibit airway hyperresponsiveness during the saline challenge (>=15% drop in FEV1) or after the completion of 15.5 minutes nebuliser time. The participant will then consume the allocated study meal. At 2 hours, a venous blood sample will be collected and lung function measured. Immediately following these measurements, the allocated study meal or water will be consumed. At 3 hours, a venous blood sample and spirometry will be performed. At 4 hours, participants will again undergo exhaled nitric oxide (eNO) measurement, blood pressure/pulse wave velocity measurement, and a venous blood sample will be collected. Lung functionwill be measured. A hypertonic saline sputum induction will be performed for a standardised 15.5 mins nebuliser time. Participants will be administered with a short acting B2-agonist (salbutamol 200ug, inhaled via a spacer) if they exhibit a >=15% drop in FEV1 during the sputum induction, or if at the completion of 15.5 minutes nebuliser time their FEV1 is >=10% below baseline, or at the patients request.
At visit 1 a skin prick allergy test will be completed, and height and weight measured. Standardised questionnaires will be completed at:
* Visit 1 only: Asthma history, medications, GINA pattern, Juniper asthma quality of life questionnaire.
* All visits: Asthma stability, Juniper asthma control quesitonnaire, 24-hour food recall diary.
Intervention code [1] 284938 0
Prevention
Comparator / control treatment
The comparator or control intervention will be 200g plain mashed potato at 0 hours and 250mL plain water at 2 hours.
Control group
Active

Outcomes
Primary outcome [1] 287242 0
Lung function (FEV1, FVC) assessed using spirometry.
Timepoint [1] 287242 0
0, 2, 3 and 4 hours
Secondary outcome [1] 297723 0
%Sputum neutrophils
Timepoint [1] 297723 0
0 and 4 hours

Eligibility
Key inclusion criteria
Non-smokers, stable asthma. Asthma will be defined by clinical history and airway hyperresponsiveness to hypertonic saline (4.5%) greater than 15% from baseline
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current smoker, BMI > 35, pregnant or breastfeeding, high blood pressure or cholesterol, 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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/07/2012
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
33
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 285361 0
Charities/Societies/Foundations
Name [1] 285361 0
Hunter Medical Research Institute
Country [1] 285361 0
Australia
Primary sponsor type
Hospital
Name
John Hunter Hospital
Address
Lookout Road
New Lambton Heights NSW 2305
Country
Australia
Secondary sponsor category [1] 284216 0
University
Name [1] 284216 0
The University of Newcastle
Address [1] 284216 0
University Drive
Callaghan NSW 2308
Country [1] 284216 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287376 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 287376 0
Lookout Road
New Lambton Heights NSW 2305
Ethics committee country [1] 287376 0
Australia
Date submitted for ethics approval [1] 287376 0
Approval date [1] 287376 0
23/06/2011
Ethics approval number [1] 287376 0
11/06/15/4.02

Summary
Brief summary
This study will investigate the mechanisms by which nutrient surplus heightens inflammatory responses and interferes with pharmacological management of asthma. Our previous work demonstrates that in asthma, consumption of a high energy mixed meal activates innate immune responses in the airways, with increased TLR4 expression and airway neutrophilia. The specific nutrient responsible for this effect is uncertain; therefore, we will assess the independent effects of saturated fat, omega-6 fat and carbohydrate. We have also observed that a high energy mixed meal leads to impaired bronchodilator responses; therefore, the effect of each of these nutrients on bronchodilator response will also be investigated. Understanding this process is vital, and highly relevant to asthma management, as effective bronchodilator response is essential for achieving good asthma control and providing bronchodilation during acute exacerbations of asthma.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34223 0
Prof Lisa Wood
Address 34223 0
Hunter Medical Research Institute
Level 2, West Wing
C/- University Drive
Callaghan NSW 2308
Australia
Country 34223 0
Australia
Phone 34223 0
+61240420147
Fax 34223 0
+61 2 4042 0046
Email 34223 0
[email protected]
Contact person for public queries
Name 17470 0
Dr Bronwyn Berthon
Address 17470 0
Hunter Medical Research Institute
Level 2, West Wing
C/- University Drive
Callaghan NSW 2308
Australia
Country 17470 0
Australia
Phone 17470 0
+61 2 4042 0116
Fax 17470 0
+61 2 4042 0046
Email 17470 0
[email protected]
Contact person for scientific queries
Name 8398 0
Prof Lisa Wood
Address 8398 0
Hunter Medical Research Institute
Level 2, West Wing
C/- University Drive
Callaghan NSW 2308
Australia
Country 8398 0
Australia
Phone 8398 0
+61 2 4042 0147
Fax 8398 0
+61 2 4042 0046
Email 8398 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 plan for IPD sharing for this trial


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Wood, LG, Li, Q, Scott, HA, Rutting, S, Berthon, B... [More Details]
Conference abstractNo Wood LG, Li Q, Berthon BS, Gibson PG, Baines KJ. S... [More Details]
Conference abstractNo LG Wood, Q Li, HA Scott, BS Berthon, PG Gibson, KJ... [More Details]

Documents added automatically
No additional documents have been identified.