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Trial registered on ANZCTR


Registration number
ACTRN12614001283662
Ethics application status
Not yet submitted
Date submitted
24/11/2014
Date registered
9/12/2014
Date last updated
9/12/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of Arnotts Vita-Weat supplementation on weight loss in overweight and obese participants.
Scientific title
A randomised controlled trial to determine the efficacy of Vita-Weat food supplementation on weight loss in overweight and obese participants.
Secondary ID [1] 285711 0
Protocol no X14-0300
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight 293581 0
Obesity 293640 0
Condition category
Condition code
Diet and Nutrition 293865 293865 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
During the six week intervention period, the intervention group will replace their breakfast and lunch each day with either 2 Arnott's Lunch Slices or up to 6 Vita-Weat crispbreads based on personal preference, with a choice of prescribed toppings consisting of a protein, vegetable and condiment component. An Accredited Practising Dietitian will administer the intervention during a one on one, face to face consultation of approximately 30 minutes duration.

To aid with dietary compliance, participants will be required to complete and return a 3 day diet diary (2 working days and 1 weekend day) at the first (Baseline) and final (Week 6) visits. Participants will receive enough product for the duration of the study.
Intervention code [1] 290661 0
Treatment: Other
Intervention code [2] 290662 0
Lifestyle
Comparator / control treatment
During the six week intervention period, participants in the ‘Control’ group will be given advice on the Australian Guide to Healthy Eating. The study dietitian will provide a guide as to the types of foods that can be bought and consumed. An Accredited Practising Dietitian will administer the intervention during a one on one, face to face consultation of approximately 30 minutes duration.

To aid with dietary compliance, participants will be required to complete and return a 3 day diet diary (2 working days and 1 weekend day) at the first (Baseline) and final (Week 6) visits . Participants will receive a grocery voucher to buy food for their diet ($20 per week).
Control group
Active

Outcomes
Primary outcome [1] 293649 0
To determine the efficacy of Vita-Weat food supplementation on weight loss in an overweight and obese group.

Weight loss will be assessed by comparing pre and post intervention weights obtained using calibrated scales.
Timepoint [1] 293649 0
Six weeks after randomisation.
Secondary outcome [1] 311519 0
To determine the difference in subjective appetite between the two diet groups.

Subjective appetite will be assessed using a 100 mm Visual Analogue Scale scores.
Timepoint [1] 311519 0
Six weeks after randomisation.
Secondary outcome [2] 311560 0
To establish the food acceptability of the two diet groups.

Food acceptability will be assessed using a Food Acceptability Questionnaires.
Timepoint [2] 311560 0
Six weeks after randomisation.
Secondary outcome [3] 311561 0
To examine changes in body composition by waist circumference, fat mass and fat free mass between groups.

Waist circumference measurement is obtained by placing a tape measure at the midline of highest point of the iliac crest and lowest part of the costal margin in the mid-axillary line in expiration.

Fat mass and fat free mass will be assessed using a DEXA scan.
Timepoint [3] 311561 0
Six weeks after randomisation.
Secondary outcome [4] 311562 0
To examine changes in type 2 diabetes and cardiovascular risk factors between groups.

This is a composite secondary outcome.

Changes in type 2 diabetes and cardiovascular risk factors will be assessed using pathological parameters including fasting plasma glucose, insulin, glycated haemoglobin, and full lipid profile. Anthropometric measures such as waist circumference and blood pressure will also contribute to the assessment of this outcome.
Timepoint [4] 311562 0
Six weeks after randomisation.

Eligibility
Key inclusion criteria
*Aged 25-55 years
*Pre-menopausal
*BMI greater than or equal to 25 to less than or equal to 35 kg /m^2
*Regular eating habits; familiar with Vita-Weat
Minimum age
25 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*Type 1 diabetes
*Type 2 diabetes treated with insulin
*Coeliac disease and gluten intolerance
*Previous bariatric surgery
*Untreated thyroid disease
*Greater than 10% change in body weight over the past 3 months
*Alcohol or illicit drug abuse
*Pregnant or breastfeeding women, and women who might be planning pregnancy during the duration of the study
*Use of weight loss medications and other drugs that may affect body weight e.g. anti-psychotics, anti-depressants, or corticosteroids
*A history or presence of malignancy [completely resected basal or squamous cell carcinoma of the skin if treatment completed > 6 months prior to enrolment and participants in remission for > 5 years prior to screening remain eligible]
*Inability to read and write English
*A history of frequently changing smoking habits, in addition to smoking cessation within 6 months prior to screening. Those who wish to take on the advice of a 'Quit' smoking programme at the time of screening will be eligible to start the trial after 6 months
*Participants may also be excluded, if in the opinion of the study investigators, they have some other condition or disorder that may adversely affect the outcome of the study or the safety of the participant

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 is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by a computer generated randomisation programme.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Assuming a mean reduction in percentage weight loss from baseline of 5% and 2% in the intervention and control treatments respectively (to Week 6), with a standard deviation (SD) of 4.5% and an estimated drop-out rate of 5%, a total of 76 participants would be required to achieve 80% power to detect a difference between the two groups (at a 2-sided significance level of 5%).
Based on these calculations, 76 participants (38 in each group) will be recruited and randomised to one of two treatment groups.
Data will be analysed for normality using the Shapiro-Wilk test. For analysis of differences between treatments, an independent sample t test, or the non-parametric equivalent Mann-Whitney U test, will be used. For within group changes, repeated measures ANOVA will be used. As well as an analysis of completers (those that attend the final visit), an intention to treat (ITT) analysis will also be included. For the ITT analysis, dropouts will be treated using a variety of sensitivity analyses.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/01/2015
Actual
Date of last participant enrolment
Anticipated
6/04/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
76
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 3204 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 8985 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 290302 0
Commercial sector/Industry
Name [1] 290302 0
Research donation from Campbell Arnott’s
Country [1] 290302 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
The Boden Institute
Charles Perkins Centre D17
John Hopkins Drive
Royal Prince Alfred Hospital
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 289012 0
None
Name [1] 289012 0
Address [1] 289012 0
Country [1] 289012 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 292007 0
Sydney Local Health District Ethics Review Committee
Ethics committee address [1] 292007 0
Ethics committee country [1] 292007 0
Australia
Date submitted for ethics approval [1] 292007 0
26/11/2014
Approval date [1] 292007 0
Ethics approval number [1] 292007 0
HREC/14/RPAH/394

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

Contacts
Principal investigator
Name 52958 0
Dr Nicholas Fuller
Address 52958 0
The Boden Institute
Charles Perkins Centre D17
Johns Hopkins Drive
Royal Prince Alfred Hospital
Camperdown NSW 2050
Country 52958 0
Australia
Phone 52958 0
+ 61 2 86271932
Fax 52958 0
+ 61 2 86270141
Email 52958 0
nick.fuller@sydney.edu.au
Contact person for public queries
Name 52959 0
Nicholas Fuller
Address 52959 0
The Boden Institute
Charles Perkins Centre D17
Johns Hopkins Drive
Royal Prince Alfred Hospital
Camperdown NSW 2050
Country 52959 0
Australia
Phone 52959 0
+ 61 2 86271932
Fax 52959 0
+ 61 2 86270141
Email 52959 0
nick.fuller@sydney.edu.au
Contact person for scientific queries
Name 52960 0
Nicholas Fuller
Address 52960 0
The Boden Institute
Charles Perkins Centre D17
Johns Hopkins Drive
Royal Prince Alfred Hospital
Camperdown NSW 2050
Country 52960 0
Australia
Phone 52960 0
+ 61 2 86271932
Fax 52960 0
+ 61 2 86270141
Email 52960 0
nick.fuller@sydney.edu.au

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

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Documents added automatically
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