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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618002040246
Ethics application status
Approved
Date submitted
27/11/2018
Date registered
20/12/2018
Date last updated
20/12/2018
Date data sharing statement initially provided
20/12/2018
Date results information initially provided
20/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does a vegetable-enriched Nothing Else (AUT trademark) bread have benefits to health?
Scientific title
Vegetable-enriched Nothing Else (AUT trademark) bread: Effects of consumption for two weeks on plasma beta carotene and lipids
Secondary ID [1] 296695 0
None
Universal Trial Number (UTN)
U1111-1224-4711
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diet and nutrition 310541 0
Condition category
Condition code
Diet and Nutrition 309253 309253 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The bread contains wheat flour, wheat bran, sweetcorn, canola oil, sprouted wheat flour, pumpkin flour, iodised salt, yeast, flaxseed and wholemeal wheat flour.
Four standard slices (50gx 4=200g) everyday to be consumed according to participants usual way of bread eating.
Pre-post study design
The study involves sampling participants blood at two baselines with one week apart for beta carotene and lipid profile concentration measurement. Participants are then required to consume the bread daily for two weeks. At the end of the two weeks of bread consumption, participant blood will again be sampled for beta carotene and lipid profile measurements.

Participants were given diary to help with the monitoring of the bread consumption.
Intervention code [1] 313008 0
Treatment: Other
Comparator / control treatment
Each person acts as their own control
Control group
Active

Outcomes
Primary outcome [1] 308227 0
Plasma beta carotene concentration analysis
Timepoint [1] 308227 0
Minus week 1, week 0 and 2 weeks blood lipids and serum beta carotene will be measured
Primary outcome [2] 308307 0
Serum lipid profile concentration (Triglycerides, HDL, LDL, Total cholesterol) analyses
Timepoint [2] 308307 0
Minus week 1, week 0 and 2 weeks blood lipids and serum beta carotene will be measured
Secondary outcome [1] 354305 0
The questionnaire was designed specifically for this study and is a 14 day record by the participant of whether the bread was eaten or not.

Timepoint [1] 354305 0
Assessed immediately following 2 weeks of consumption

Eligibility
Key inclusion criteria
Regular bread eaters
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Consumption of vitamin A supplement, liver conditions and allergy to gluten

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
None
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
None
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Two measures prior to consumption of bread
Phase
Not Applicable
Type of endpoint(s)
Bio-availability
Statistical methods / analysis
Analysis of Covariance

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21064 0
New Zealand
State/province [1] 21064 0
Auckland

Funding & Sponsors
Funding source category [1] 301274 0
University
Name [1] 301274 0
Auckland University of Technology
Address [1] 301274 0
640 Great South Road, Manukau 2025
Country [1] 301274 0
New Zealand
Funding source category [2] 301275 0
Government body
Name [2] 301275 0
Riddet Institute Centre of Research Excellence
Address [2] 301275 0
Massey University, Private Bag 11222, Palmerston North 4442, New Zealand
Country [2] 301275 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology
Address
Auckland University of Technology
640 Great South Road, Manukau 2025
Country
New Zealand
Secondary sponsor category [1] 300919 0
None
Name [1] 300919 0
NA
Address [1] 300919 0
NA
Country [1] 300919 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302016 0
Auckland University of Technology Ethics Committee
Ethics committee address [1] 302016 0
Auckland University of Technology
Private Bag 92006
Auckland 1142
Ethics committee country [1] 302016 0
New Zealand
Date submitted for ethics approval [1] 302016 0
05/07/2018
Approval date [1] 302016 0
14/11/2018
Ethics approval number [1] 302016 0
18/146

Summary
Brief summary
Participants will attend the Nutrition and Metabolism Laboratory at AUT South Campus. They will be required to report to the Nutrition and Metabolism Laboratory at the AUT South Campus on 3 mornings. At the first two baseline visits ( one week apart), blood will be drawn by a phlebotomist and measured for ß-Carotenes and lipid profile concentration. Participants will be provided with fifty-six standard slices (50g of each slice) of a vegetable-enriched Nothing Else (AUT trademark) test bread during their second visit and will be asked to consume four slices daily for a period of two weeks. Participants will again visit the laboratory for a further sample. The plasma blood sample prepared for ß-Carotenes will be frozen until ready to be transported to Christchurch for ß-Carotene analyses. It is hypothesized that the plasma ß-Carotenes and lipid profile concentration will be improved after two weeks of daily consumption of the vegetable-enriched Nothing Else (AUT trademark) bread.
Trial website
None
Trial related presentations / publications
None to date
Public notes

Contacts
Principal investigator
Name 88858 0
Prof Elaine Rush
Address 88858 0
Professor of Nutrition
Auckland University of Technology
Private Bag 92006
Auckland 1142
Country 88858 0
New Zealand
Phone 88858 0
+64 99219999
Fax 88858 0
Email 88858 0
elaine.rush@aut.ac.nz
Contact person for public queries
Name 88859 0
Prof Elaine Rush
Address 88859 0
Professor of Nutrition
Auckland University of Technology
Private Bag 92006
Auckland 1142
Country 88859 0
New Zealand
Phone 88859 0
+64 99219999
Fax 88859 0
Email 88859 0
elaine.rush@aut.ac.nz
Contact person for scientific queries
Name 88860 0
Prof Elaine Rush
Address 88860 0
Professor of Nutrition
Auckland University of Technology
Private Bag 92006
Auckland 1142
Country 88860 0
New Zealand
Phone 88860 0
+64 99219999
Fax 88860 0
Email 88860 0
elaine.rush@aut.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethical approval for this not obtained
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary