Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000599875
Ethics application status
Approved
Date submitted
25/07/2011
Date registered
4/06/2012
Date last updated
26/11/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of fructose and high fat feeding on the regulation of hunger and satiety.
Scientific title
The effect of fructose and high fat feeding on the regulation of hunger and satiety in healthy, lean individuals.
Secondary ID [1] 280603 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 268393 0
Condition category
Condition code
Diet and Nutrition 268534 268534 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1) Soda Water Group 2) Soda Water + artificial sweetener Group (Splenda) 3) Soda Water + 15% fructose Group 4) Soda Water + 15% glucose (all groups containing lemon flavouring). All groups will be asked to consume a Big Mac Meal. The volume of the drink that will be administered is 375mls. The meal and drink will only be administered once simutaneously over a period over 15mins (from t=0 to t= 15). The participants will be offered some light refreshments at the end of each visit. Each participant is required to complete all 4 test groups (one group per visit). The order of the groups are randomised.
Intervention code [1] 267040 0
Behaviour
Comparator / control treatment
The placebo group in this study is Group 1) Soda water
Control group
Placebo

Outcomes
Primary outcome [1] 269285 0
The primary outcome of this study is to understand the effects of a high fat meal with or without fructose on hormones/peptides which can affect hunger and satiety including CCK, PYY, Leptin, Ghrelin, Adiponectin, GLP-1, GIP, PP, Glucose, Insulin and Amylin using an ELISA Assay Kit.
Timepoint [1] 269285 0
0, 15, 30, 60, 120 minutes
Secondary outcome [1] 279297 0
In addition, a Visual Analogue Scale test will also be performed at the end of each point after consuming the meal to determine the satiety effects using a visual scale (0-10cm).
Timepoint [1] 279297 0
0, 15, 30, 60, 120 minutes

Eligibility
Key inclusion criteria
Individual with stable weight (i.e. no more than 3kg gain/loss in the last 3 months) and no major health problems.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
People whose primary language is other than English (LOTE),
Women who are pregnant and the human foetus, Children and/or young people (ie.<18 years), People highly dependent on medical care and people with a cognitive impairment, an intellectual disability or a mental illness.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2012
Actual
25/07/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267514 0
Government body
Name [1] 267514 0
National Health and Medical Research Council
Country [1] 267514 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
145 Studley Road
Heidelberg Heights
VIC 3084
Country
Australia
Secondary sponsor category [1] 266557 0
None
Name [1] 266557 0
Address [1] 266557 0
Country [1] 266557 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269481 0
Austin Human Research Ethics Committee
Ethics committee address [1] 269481 0
Research Ethics
Office for Research
Level 8 HSB Austin Health
145 Studley Road
Heidelberg
Victoria
Australia, 3084
Ethics committee country [1] 269481 0
Australia
Date submitted for ethics approval [1] 269481 0
Approval date [1] 269481 0
03/08/2010
Ethics approval number [1] 269481 0
03947

Summary
Brief summary
The aim of this project is to determine the effects of fructose feeding on fat-induced weight gain in humans. The hypothesis is that the satiety effect will be greater in those consuming a high fat meal with fructose as oppose to water or non-sugary drink.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 32916 0
Prof Joseph Proietto
Address 32916 0
Heidelberg Repatriation Hospital, Boronia Building I, 300 Waterdale Rd, Heidelberg Heights, Vic, 3081.
Country 32916 0
Australia
Phone 32916 0
+61 3 9496 2250
Fax 32916 0
Email 32916 0
j.proietto@unimelb.edu.au
Contact person for public queries
Name 16163 0
Dr Nicole Wong
Address 16163 0
Austin Hospital (LTB 7)
145 Studley Road
Heidelberg
VIC 3084
Country 16163 0
Australia
Phone 16163 0
+61 3 9496 3592
Fax 16163 0
+61 3 9457 5485
Email 16163 0
wongn@unimelb.edu.au
Contact person for scientific queries
Name 7091 0
Dr Nicole Wong
Address 7091 0
Austin Hospital (LTB 7)
145 Studley Road
Heidelberg
VIC 3084
Country 7091 0
Australia
Phone 7091 0
+61 3 9496 3592
Fax 7091 0
+61 3 9457 5485
Email 7091 0
wongn@unimelb.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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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