Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000125628
Ethics application status
Approved
Date submitted
9/08/2005
Date registered
11/08/2005
Date last updated
23/10/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Whole Foods versus Supplements to Reduce Oxidative Stress in the Airways
Scientific title
A placebo-controlled, cross-over, supplementation trial establishing the comparative efficacy of lycopene capsules and tomato juice on airway hyperresponsiveness in stable asthma
Secondary ID [1] 111 0
Whole Foods Study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 213 0
Condition category
Condition code
Respiratory 239 239 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects receive three treatments in random order, each for 7 days. The treatments are tomato juice (840mL/day), lycomato extract (3 capsules /day) and placebo (3 capsules /day). The tomato juice and lycomato provide a lycopene dose of 45mg /day. Before and between each treatment subjects undergo a 10 day washout period on a low antioxidant diet.
Intervention code [1] 149 0
Treatment: Other
Comparator / control treatment
Placebo (3 capsules /day).
Control group
Placebo

Outcomes
Primary outcome [1] 285 0
Airways hyperresponsiveness after 7 days treatment.
Timepoint [1] 285 0
After 7 days treatment.
Secondary outcome [1] 629 0
Airway oxidative stress levels (sputum 8-isoprostane).
Timepoint [1] 629 0
After 7 days treatment.

Eligibility
Key inclusion criteria
Current asthmatics.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.) Current smokers2.) Other respiratory diseases3.) Unable to produce sputum sample4.) Currently using vitamin or herbal supplement.

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)
Allocation concealed by blinded list held by investigator independent of participant or research officer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random number sequence
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2004
Actual
27/05/2004
Date of last participant enrolment
Anticipated
Actual
14/09/2005
Date of last data collection
Anticipated
Actual
12/12/2005
Sample size
Target
20
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 298 0
Government body
Name [1] 298 0
NHMRC
Country [1] 298 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Area Health Service
Address
Country
Australia
Secondary sponsor category [1] 231 0
None
Name [1] 231 0
None
Address [1] 231 0
Country [1] 231 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1168 0
John Hunter Hospital (Hunter New England Area Health Service) University of Newcastle
Ethics committee address [1] 1168 0
Ethics committee country [1] 1168 0
Australia
Date submitted for ethics approval [1] 1168 0
31/01/2004
Approval date [1] 1168 0
01/03/2004
Ethics approval number [1] 1168 0

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

Contacts
Principal investigator
Name 35305 0
Address 35305 0
Country 35305 0
Phone 35305 0
Fax 35305 0
Email 35305 0
Contact person for public queries
Name 9338 0
Dr Lisa Wood
Address 9338 0
Respiratory & Sleep Medicine
Hunter Medical Research Institute
John Hunter Hospital
Level 3
New Lambton NSW 2305
Country 9338 0
Australia
Phone 9338 0
+61 2 49855677
Fax 9338 0
+61 2 49855850
Email 9338 0
[email protected]
Contact person for scientific queries
Name 266 0
Dr Lisa Wood
Address 266 0
Respiratory & Sleep Medicine
Hunter Medical Research Institute
John Hunter Hospital
Level 3
New Lambton NSW 2305
Country 266 0
Australia
Phone 266 0
+61 2 49855677
Fax 266 0
+61 2 49855850
Email 266 0
[email protected]

No information has been provided regarding IPD availability


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.