Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000280808
Ethics application status
Approved
Date submitted
11/01/2021
Date registered
12/03/2021
Date last updated
4/10/2024
Date data sharing statement initially provided
12/03/2021
Date results provided
4/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect on the satiation properties of dietary fat during co-ingestion with low energy dense carbohydrate
Scientific title
The effect on satiation of a fat preload during co-ingestion of low energy dense carbohydrate: a randomised controlled trial of healthy adult male subjects
Secondary ID [1] 303063 0
None
Universal Trial Number (UTN)
U1111-1263-0248
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
overweight 320125 0
obesity 320126 0
Condition category
Condition code
Diet and Nutrition 318071 318071 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be asked to present at 4 x test sessions of approximately one hour duration, facilitated by the Chief Investigator of this research project. Participants will be served a breakfast to be taken ad libitum. The degree of satiation will be assessed via the measurement of the energy intake of food consumed prior to the voluntary cessation of eating and by the recording of patient appetite sensations using Visual Analogue Scales (VAS). There will be two intervention arms. Arm 1: a preload containing 20g of fat followed by a low energy dense carbohydrate meal; and Arm 2: a preload containing 60g of fat followed by a low energy dense carbohydrate meal. Consumption of the preload will be verified and recorded by the researcher. After a period of fifteen minutes the subject will be asked to consume the test meal. Subjects will be asked to eat at a consistent rate by means of a metronome but only until a point of pleasant fullness has been reached. Meals will be matched for palatability prior to the commencement of the study.
Intervention code [1] 319347 0
Prevention
Intervention code [2] 319348 0
Lifestyle
Intervention code [3] 319674 0
Behaviour
Comparator / control treatment
The control will consist of two arms. Control Arm 1: a preload containing 20g of fat followed by a higher energy dense carbohydrate meal; and Control Arm 2: a preload containing 60g of fat followed by a higher energy dense carbohydrate meal.
Control group
Active

Outcomes
Primary outcome [1] 326080 0
Before the commencement of the meal, the dish containing the meal will be weighed. At the completion of the meal the dish will again be weighed, the difference in the weight of the dish between the commencement and completion of the meal being the weight of food consumed. Energy intake of food will be calculated by measuring net quantity of food consumed by participants and assessing the number of kilojoules ingested by means of the nutrition app FoodWorks.
Timepoint [1] 326080 0
Point of participant satiation (meal termination).
Secondary outcome [1] 390059 0
Minutes to meal termination as assessed with a timer to be activated at the point where participant has been instructed to consume the test meal
Timepoint [1] 390059 0
Point of participant satiation (meal termination).

Eligibility
Key inclusion criteria
Adult males with a BMI of between 18.5 and 24.9 kg/m² (inclusive).
Minimum age
18 Years
Maximum age
40 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any potential participants having a metabolic or gastrointestinal condition, food allergy, thyroid issues, insulin resistance, cardiovascular disease or being a smoker will be excluded from the study.

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 involved contacting the holder of the allocation schedule who was "off-site" or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e.
https://www.random.org/lists/)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Difference in energy intake and time to satiation between the low energy density carbohydrate and higher energy density carbohydrate groups will be analysed by a t-test. Difference in VAS scores between the two groups will be analysed by a Wilcoxon signed rank test.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
31/03/2021
Actual
6/05/2021
Date of last participant enrolment
Anticipated
31/03/2023
Actual
31/03/2023
Date of last data collection
Anticipated
30/04/2023
Actual
30/04/2023
Sample size
Target
29
Accrual to date
Final
6
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment postcode(s) [1] 32334 0
2617 - Bruce

Funding & Sponsors
Funding source category [1] 307471 0
University
Name [1] 307471 0
University of Canberra
Country [1] 307471 0
Australia
Primary sponsor type
University
Name
University of Canberra
Address
11 Kirinari St, Bruce ACT 2617
Country
Australia
Secondary sponsor category [1] 308142 0
None
Name [1] 308142 0
Address [1] 308142 0
Country [1] 308142 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307547 0
University of Canberra Human Research Ethics Committee
Ethics committee address [1] 307547 0
Ethics committee country [1] 307547 0
Australia
Date submitted for ethics approval [1] 307547 0
14/11/2019
Approval date [1] 307547 0
15/01/2020
Ethics approval number [1] 307547 0
20202301

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

Contacts
Principal investigator
Name 107626 0
Mr Andrew Warrilow
Address 107626 0
University of Canberra
11 Kirinari St, Bruce ACT 2617
Country 107626 0
Australia
Phone 107626 0
+61 434250436
Fax 107626 0
Email 107626 0
[email protected]
Contact person for public queries
Name 107627 0
Nenad Naumovski
Address 107627 0
University of Canberra
11 Kirinari St, Bruce ACT 2617
Country 107627 0
Australia
Phone 107627 0
+61262015111
Fax 107627 0
Email 107627 0
[email protected]
Contact person for scientific queries
Name 107628 0
Nenad Naumovski
Address 107628 0
University of Canberra
11 Kirinari St, Bruce ACT 2617
Country 107628 0
Australia
Phone 107628 0
+61262015111
Fax 107628 0
Email 107628 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.