Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000890538
Ethics application status
Approved
Date submitted
14/08/2015
Date registered
26/08/2015
Date last updated
26/08/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Gender differences in fat preference and perception in healthy volunteers.
Scientific title
Gender differences in fat taste preferences and perception in healthy volunteers.
Secondary ID [1] 287277 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 295910 0
Condition category
Condition code
Diet and Nutrition 296160 296160 0 0
Obesity
Oral and Gastrointestinal 296161 296161 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be exposed to four different taste sessions. The first two session will involve fat taste sensitivity tests (on paper and in milk in randomised order) and the last two involve preference for salt/fat combinations and preference for sugar/fat concentrations (in randomised order).
The oral fat taste sensitivity tests will be assessed by using a three ascending forced choice tests. Participants will be asked to identify the "odd" tasting sample from three samples (two controls and one fat containing sample), in ascending concentration of fat, in which the lowest detectable fatty acid concentration will be identified. The detection threshold was defined as the concentration that was correctly identified as the odd sample three consecutive times. The total number of tests carried out will depend on the ability to taste fat. This will be done by using milk as base (one session) or filter paper (one session). In the filter paper session, the fatty acid concentrations or control (mineral oil) is loaded onto filter paper placed on participants tongue. The following concentrations of oleic acid (C18:1) are used in the fat taste sensitivity test: 0.02, 0.06., 1, 1.4, 2, 2.8, 3.8, 5, 6.4, 8, 9.8, 12, 20 mM.
Participants will taste food samples with different salt and fat concentrations (tomato soup) and different sugar and fat concentrations (custard). Food samples will be 15 ml.
There will be 16 salt/fat combinations and 16 sugar/fat combinations. Salt concentrations are 0, 0.35, 0.7 and 1.5% salt. Sugar concentrations are 0, 5, 10 and 20%. Fat concentrations are 0. 5, 10 and 20%. The duration of the sessions will be between 30 - 90 minutes, with at least two days in between the sessions.
Intervention code [1] 292587 0
Behaviour
Intervention code [2] 292643 0
Prevention
Comparator / control treatment
This is a within subjects design, participants are their own controls (ratings at 0% fat, salt, sugar against higher concentrations)
Control group
Active

Outcomes
Primary outcome [1] 295839 0
Gender differences in subjective ratings of pleasantness by using a 100mm visual analogue scale
Timepoint [1] 295839 0
Directly after tasting the food sample (1 min)
Secondary outcome [1] 316677 0
fat taste sensitivity
Timepoint [1] 316677 0
assessed by an ascending forced choice test, total duration depends on sensitivity (between 30 - 90 min).
Responses to each test are given immediately after tasting (1-2 minutes)

Eligibility
Key inclusion criteria
Healthy adult participants
BMI (18.5-25 kg/m2)
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
smoking
being pregnant or give breastfeeding
difficulties with eating or swallowing

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)
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
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/08/2015
Actual
10/08/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 291837 0
University
Name [1] 291837 0
Deakin University
Country [1] 291837 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood highway, Burwood, vic 3125
Country
Australia
Secondary sponsor category [1] 290505 0
None
Name [1] 290505 0
Address [1] 290505 0
Country [1] 290505 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293355 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 293355 0
Ethics committee country [1] 293355 0
Australia
Date submitted for ethics approval [1] 293355 0
Approval date [1] 293355 0
06/08/2015
Ethics approval number [1] 293355 0
2014-122

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

Contacts
Principal investigator
Name 59534 0
Dr Dieuwerke Bolhuis
Address 59534 0
221 Burwood highway, Burwood, VIC 3125
Country 59534 0
Australia
Phone 59534 0
+61 3 92468215
Fax 59534 0
Email 59534 0
[email protected]
Contact person for public queries
Name 59535 0
Dieuwerke Bolhuis
Address 59535 0
221 Burwood highway, Burwood, VIC 3125
Country 59535 0
Australia
Phone 59535 0
+61 3 92468215
Fax 59535 0
Email 59535 0
[email protected]
Contact person for scientific queries
Name 59536 0
Russell Keast
Address 59536 0
221 Burwood highway, Burwood, VIC 3125
Country 59536 0
Australia
Phone 59536 0
+61 3 92446944
Fax 59536 0
Email 59536 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
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