Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001019796
Ethics application status
Approved
Date submitted
3/09/2013
Date registered
12/09/2013
Date last updated
30/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
How healthy adults determine food portion sizes
Scientific title
The effects of food cue manipulations on pre-meal planning and actual food intake in healthy adults
Secondary ID [1] 283130 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Portion size selection and food consumption 289981 0
Condition category
Condition code
Diet and Nutrition 290361 290361 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study design: Randomized, controlled, crossover design

Test foods:
1. Visual manipulations
a. Visible fat – energy-matched butter on toasted French bread
b. Visible sugar – energy-matched jam on toasted French bread
c. Visible protein – energy-matched ham on toasted French bread
d. Visible protein – energy-matched cream cheese on toasted French bread
2. Olfactory manipulations
a. Natural odour – plain mashed potato with Italian herbs
b. “Fat” odour – herbs + butter or bacon essence added to mashed potato
3. Food form manipulations
a. Solid – apple
b. Liquid – apple juice

Participants will be screened at baseline to confirm eligibility and baseline measurements will be obtained. If qualified, participants will attend eight 45-minute sessions to undergo all study conditions in a random order. Participants will be asked to avoid vigorous activity and drinking alcohol on the previous day, and fast for 10 – 12 hours prior to each session. Participants will arrive at the laboratory between 8am and 9am, and overnight fasting will be verbally confirmed by the researcher. Upon arrival, participants will be asked to drink 200ml of plain water (as a control for thirst and baseline hunger), and baseline appetite ratings will be assessed using validated visual analog scales (VAS) (Flint 2000) 5 minutes after water consumption. Test foods will be presented in large portion sizes (to avoid portion bias and to prevent plate-cleaning), and participants will be asked to take a portion of the test food that is expected to help them achieve a fullness level of 8 out of 10. Participants will also be asked to rate the appearance and intensity of smell of foods. Following that, the portioned food will be removed, and an identical plate of food will be presented to participants again. They will be given 30 minutes to consume the same food until a fullness level of 8 is achieved. After 30 minutes, participants will be asked to rate the palatability of the test foods, how often they will consume the same food again, and VAS again before leaving the lab. Participants will return until all conditions are completed.

The washout period between study visits will be at least 24 hours.
Intervention code [1] 287851 0
Other interventions
Comparator / control treatment
There is no control in this experiment, comparison will be done relative to other conditions.
Control group
Active

Outcomes
Primary outcome [1] 290390 0
Expected satiation (as amount of food selected) in grams
Timepoint [1] 290390 0
At each feeding session
Primary outcome [2] 290471 0
Actual satiation (as amount of food consumed) in grams
Timepoint [2] 290471 0
At each feeding session
Secondary outcome [1] 304393 0
Food palatability ratings using visual analog scales
Timepoint [1] 304393 0
At each feeding session
Secondary outcome [2] 304568 0
Appetite ratings using visual analog scales
Timepoint [2] 304568 0
Before and after test meal consumption at each session

Eligibility
Key inclusion criteria
* Males and females
* Age 18-60 years
* BMI 18.5 – 35 kgm-2
* Not taking medications that affect metabolism or appetite
* Non-smokers
* Are familiar with test foods
* Willing to comply to study protocol
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Presence of disease(s)
* Food allergies or intolerance

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Order of foods received by each participant will be randomized using a computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on our previous study with similar study design where food form was manipulated (beverage vs. solid) (Houchins 2012), consumption of challenge meals were 186 +/- 163 kcal for solid and 326 +/- 169 kcal for beverage preloads. Based on these, to detect an effect of similar magnitude in this proposed study at 80% power will require 12 participants (a=0.05) to complete the study. However, we anticipate the difference to be smaller between other test conditions (visual and olfactory manipulations). Food consumption data from other studies is not available, but a difference of 75 kcal between test meals within each manipulation is considered appropriate since it represent a difference of approximately one serving size of the test foods (bread and mashed potato). Using this expected difference, 40 participants are required to achieve statistical power of 80% at a=0.05.

Statistical analyses:
* One-way ANOVA
* Correlation
* Paired t-test

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2013
Actual
31/10/2013
Date of last participant enrolment
Anticipated
Actual
11/08/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 7303 0
5001 - Adelaide

Funding & Sponsors
Funding source category [1] 287881 0
University
Name [1] 287881 0
University of South Australia
Country [1] 287881 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
School pf Pharmacy and Medical Sciences
City East Campus, North Terrace, GPO Box 2471
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 286608 0
None
Name [1] 286608 0
Address [1] 286608 0
Country [1] 286608 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289822 0
Human Research Ethics Committee
Ethics committee address [1] 289822 0
Ethics committee country [1] 289822 0
Australia
Date submitted for ethics approval [1] 289822 0
09/09/2013
Approval date [1] 289822 0
11/10/2013
Ethics approval number [1] 289822 0
0000031902

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

Contacts
Principal investigator
Name 42602 0
Dr Sze Yen Tan
Address 42602 0
School of Pharmacy and Medical Sciences
City East Campus, North Terrace, GPO Box 2471
Adelaide SA 5001
Country 42602 0
Australia
Phone 42602 0
+61 8 8302 1399
Fax 42602 0
Email 42602 0
[email protected]
Contact person for public queries
Name 42603 0
Sze Yen Tan
Address 42603 0
School of Pharmacy and Medical Sciences
City East Campus, North Terrace, GPO Box 2471
Adelaide SA 5001
Country 42603 0
Australia
Phone 42603 0
+61 8 8302 1399
Fax 42603 0
Email 42603 0
[email protected]
Contact person for scientific queries
Name 42604 0
Sze Yen Tan
Address 42604 0
School of Pharmacy and Medical Sciences
City East Campus, North Terrace, GPO Box 2471
Adelaide SA 5001
Country 42604 0
Australia
Phone 42604 0
+61 8 8302 1399
Fax 42604 0
Email 42604 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.