ANZCTR - Registration

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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 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]

Nil Known

Universal Trial Number (UTN)

Trial acronym

FAT

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Asthma

Healthy Controls

Condition category

Condition code

Respiratory

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]

Other interventions

Comparator / control treatment

Control = Low energy diet (75% Recommended Daily Energy Intake).

Control group

Dose comparison

Outcomes

Primary outcome [1]

Plasma IL-6, assessed by Enzyme Immuno Assay

Timepoint [1]

At 0, 4 and 24 hours

Secondary outcome [1]

Sputum neutrophils

Timepoint [1]

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?

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

Accrual to date

Final

129

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

John Hunter Hospital Royal Newcastle Centre - New Lambton

Recruitment postcode(s) [1]

2305 - New Lambton Heights

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

John Hunter Hospital Charitable Trust Fund

Address [1]

Lookout Rd, New Lambton Heights, 2305, NSW, Australia

Country [1]

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]

None

Name [1]

none

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

John Hunter Hospital-University of Newcastle

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

13/12/2007

Ethics approval number [1]

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

Prof Lisa Wood

Address

Centre for Asthma and Respiratory Diseases
Level 2, West Wing, HMRI Building
Kookaburra Crt
New Lambton Heights, NSW, 2305

Country

Australia

Phone

+61 2 40420147

Fax

+61 2 40420046

[email protected]

Contact person for public queries

Name

Bronwyn Berthon

Address

Centre for Asthma and Respiratory Diseases
Level 2, West Wing, HMRI Building
Kookaburra Crt
New Lambton Heights, NSW, 2305

Country

Australia

Phone

+61 2 40420116

Fax

+61 2 40420046

[email protected]

Contact person for scientific queries

Name

Dr Lisa Wood

Address

Centre for Asthma and Respiratory Diseases
Level 2, West Wing, HMRI Building
Kookaburra Crt
New Lambton Heights, NSW, 2305

Country

Australia

Phone

+61 2 40420147

Fax

+61 2 40420046

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Soluble fibre meal challenge reduces airway inflammation and expression of GPR43 and GPR41 in asthma.	2017	https://dx.doi.org/10.3390/nu9010057

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically