Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001091594
Ethics application status
Approved
Date submitted
7/10/2015
Date registered
19/10/2015
Date last updated
19/10/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of oral sensory exposure on pork sensory specific satiety: a functional magnetic resonance imaging study
Scientific title
Effect of oral sensory exposure on pork sensory specific satiety: a functional magnetic resonance imaging study study in healthy human subjects
Secondary ID [1] 287628 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
neural activation in healthy adults 296443 0
subjective appetite in healthy subjects 296444 0
Condition category
Condition code
Neurological 296708 296708 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will employ a randomized, two way cross-over design. All participants act as their own control. Participants will be tested on two separate days (one week washout time in between) with one of two interventions:
(1) A placebo chewing gum + standardized breakfast
(2) A pork flavored chewing gum + standardized breakfast

The flavour added to the pork flavored chewing gum related to a mixture of 2 pork ham flavours (5% Acorde JAMON1, 10% Acorde JAMON 2; Lucta SA, Montornes del Valles, Spain) , 5% monosodium glutamate (MSG) (Ajinomoto Inc., Japan), 0.05% inosine monophosphate (IMP, 4666803) and 0.05% guanosine monophosphate (GMP, 2421617) (Givaudan Australian Pty Ltd). This mimic real pork flavor (aroma and taste).

The breakfast consisted of 100g pork (cooked ham), 125g boiled rice, 50g fresh apple and 200ml of pure water. The calculated nutritional content of the meal was 1309KJ, 21.8g of crude protein, 7.5g of total fat and 40.3g of carbohydrate. Pork was the predominant protein source.

On the testing days, participants will arrive at the lab after an overnight fast, Participants will receive a chewing gum (either placebo or pork-flavored) and will be asked to chew for 7 min (chew rate between 25-30 times per min using a metronome) before they eat the breakfast. Participants will complete two brain scanning sessions: one baseline at arrival (pre-intervention) and the other one at 60 minutes after breakfast (post-intervention) with four categories of food cues (cake, meat, fruit and salad) shown as images alone or as combined image and congruent odors. Subjective ratings of food cues were measured during scanning as a measure of sensory specific satiety. Subjective specific appetite for sweet, savoury, fatty and salty foods were evaluated outside the scanner to test the transference of pork sensory specific satiety.
Intervention code [1] 293030 0
Treatment: Other
Comparator / control treatment
This is a within subjects design, participants are their own controls (receiving placebo chewing gum and pork-flavored chewing gum)

the placebo chewing gum is a 3-gram commercial gum base;
the pork-flavored gum is a 3-gram chewing gum made based on the placebo gum, with addition of the flavor compounds listed above.
Control group
Active

Outcomes
Primary outcome [1] 296320 0
fMRI data will be collected to investigate whether the brain reward regions activations to food cues before and after the chewing gum + breakfast treatments.
Timepoint [1] 296320 0
At arrival (before the treatment) and at 60 minutes after the treatment
Primary outcome [2] 296321 0
Ratings on a 13-points scales for the pleasantness of each category of food cues during scanning as a measurment of subjective sensory specific satiety
Timepoint [2] 296321 0
At arrival (before treatment) and at 60 min after the treatment
Secondary outcome [1] 318146 0
A composite measurement for sensory specific appetite for four foods with four different flavor (sweet, savory, fatty and salty flavor foods) using visual analogue scale.
Timepoint [1] 318146 0
Arrival; after the pre-treatment fMRI scan; 0 min after the treatment; 30 min after the treatment; 60 min after the treatment; and after the post-treatment fMRI scan

Eligibility
Key inclusion criteria
BMI (18.5-25.9), Right-handed, non-smokers, medication free, non-pregnant, no food allergies; non-vegetarianism; Safety for MRI scanning; Not cognitive dietary restraint (factor 1 score < 13 measured by the three factor eating questionnaire)
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Psychiatric or neurological illness; gustatory, gastrointestinal, olfactory or eating dysfunction; a body mass index (BMI) over 25.9 or below 18.5; drug or medication use; smoking; pregnancy; food allergies; vegetarianism; non breakfast eaters or a change in weight > 5kg in the past 2 months. Not safety for MRI scanning; cognitive dietary restraint

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
30/08/2013
Date of last participant enrolment
Anticipated
Actual
5/04/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
16
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 292191 0
Commercial sector/Industry
Name [1] 292191 0
Australian Pork CRC
Country [1] 292191 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
The University of Queensland, St Lucia,4072, Brisbane, QLD
Country
Australia
Secondary sponsor category [1] 290869 0
University
Name [1] 290869 0
Center for Nutrition and Food Sciences
Address [1] 290869 0
Hartley Teakle Building (#83), the University of Queensland, St Lucia,4072, Brisbane, QLD
Country [1] 290869 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293664 0
The University of Queensland Medical Research Ethics Committee
Ethics committee address [1] 293664 0
Ethics committee country [1] 293664 0
Australia
Date submitted for ethics approval [1] 293664 0
Approval date [1] 293664 0
12/04/2013
Ethics approval number [1] 293664 0
2013000254

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

Contacts
Principal investigator
Name 60874 0
Mr PENGFEI HAN
Address 60874 0
C504 Hartley Teakle Building (83#), Center for Nutrition and Food Sciences, the University of Queensland, St Lucia, 4072, QLD
Country 60874 0
Australia
Phone 60874 0
+61 426 882 330
Fax 60874 0
Email 60874 0
[email protected]
Contact person for public queries
Name 60875 0
Eugeni Roura
Address 60875 0
S435 Hartley Teakle Building (83#), Center for Nutrition and Food Sciences, the University of Queensland, St Lucia, 4072, QLD
Country 60875 0
Australia
Phone 60875 0
+61 (0)7 3365 2526
Fax 60875 0
Email 60875 0
[email protected]
Contact person for scientific queries
Name 60876 0
PENGFEI HAN
Address 60876 0
C504 Hartley Teakle Building (83#), Center for Nutrition and Food Sciences, the University of Queensland, St Lucia, 4072, QLD
Country 60876 0
Australia
Phone 60876 0
+61 426 882 330
Fax 60876 0
Email 60876 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.