Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000747123
Ethics application status
Approved
Date submitted
8/05/2019
Date registered
20/05/2019
Date last updated
20/05/2019
Date data sharing statement initially provided
20/05/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
How consuming different types of rice flour affects how hungry you feel in healthy Australian adults.
Scientific title
The effect of consuming rice flour beverages and carbohydrate taste sensitivity on subsequent food consumption and satiety in healthy Australian adults..
Secondary ID [1] 298143 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 312683 0
Condition category
Condition code
Diet and Nutrition 311181 311181 0 0
Obesity
Metabolic and Endocrine 311367 311367 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Consumption of 1 x 200 g drink (treatment) made from either jasmine rice flour or riceberry rice flour in water (6.31% w/v). Treatments (including the control) are provided on separate days, in a random order and are to be drunk within five minutes. Adherence is measured via direct supervision. Washout period between drinks is at least 24 hours.
3 hours after treatment, participants are presented with an ad libitum buffet-style lunch and asked to eat until comfortably full.
Intervention code [1] 314361 0
Treatment: Other
Intervention code [2] 314507 0
Prevention
Comparator / control treatment
Consumption of a 200 mL drink made from oligofrustose in water (6.31% w/v).
Control group
Active

Outcomes
Primary outcome [1] 319944 0
Self-reported satiety ratings using a 100 mm visual analogue scale
Timepoint [1] 319944 0
Immediately prior to treatment (baseline), 3 hours post treatment and following ad libitum buffet.
Primary outcome [2] 319945 0
Food intake based on an ad libitum buffet. Food intake measured via weight using balanced scales (g food supplied - g food returned at the end of buffet)..
Timepoint [2] 319945 0
3 hours post treatment..
Secondary outcome [1] 369957 0
Carbohydrate taste sensitivity measured using an ascending concentration 3-alternate forced choice test. Three samples of solution are served to the participant, where, two samples are control samples (filtered deionised water) and one sample contains oligofructose solution.
Timepoint [1] 369957 0
Immediately prior to treatment (baseline), 3 hours post treatment.

Eligibility
Key inclusion criteria
- 18-55 years of age
- A non-smoker
- Have no known allergies
- Currently not pregnant or planning a pregnancy within the 6 month duration of the study
- Capable of fasting overnight
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria included individuals who were: smokers, pregnant or lactating, taking any prescription medication that may interfere with their ability to taste, and were not able to consume a normal diet due to health problems at the time of testing.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was concealed using unmarked drinking cups. All participants received the same styled drinking cup for each treatment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software. Participants were allocated a randomised sequence in order of date recruited.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/05/2018
Date of last participant enrolment
Anticipated
Actual
27/08/2018
Date of last data collection
Anticipated
Actual
21/09/2018
Sample size
Target
40
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 26415 0
3125 - Burwood

Funding & Sponsors
Funding source category [1] 302668 0
University
Name [1] 302668 0
Deakin University, Centre for Advanced Sensory Science
Country [1] 302668 0
Australia
Primary sponsor type
Individual
Name
Professor Russell Keast
Address
Deakin University
Centre for Advanced Sensory Science
School of Exercise and Nutrition Sciences
221 Burwood Hwy, Burwood, 3125,
VIC
Country
Australia
Secondary sponsor category [1] 302648 0
None
Name [1] 302648 0
Address [1] 302648 0
Country [1] 302648 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303291 0
Deakin University Human Ethics Advisory Group Health (HEAG-H)
Ethics committee address [1] 303291 0
Ethics committee country [1] 303291 0
Australia
Date submitted for ethics approval [1] 303291 0
26/03/2018
Approval date [1] 303291 0
10/05/2018
Ethics approval number [1] 303291 0
HEAG-H 44_2018:

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

Contacts
Principal investigator
Name 93154 0
Prof Russell Keast
Address 93154 0
Deakin University
221 Burwood Hwy
Burwood 3125
Vic
Country 93154 0
Australia
Phone 93154 0
+61 03 92446944
Fax 93154 0
Email 93154 0
[email protected]
Contact person for public queries
Name 93155 0
Russell Keast
Address 93155 0
Deakin University
221 Burwood Hwy
Burwood 3125
Vic
Country 93155 0
Australia
Phone 93155 0
+61 03 92446944
Fax 93155 0
Email 93155 0
[email protected]
Contact person for scientific queries
Name 93156 0
Russell Keast
Address 93156 0
Deakin University
221 Burwood Hwy
Burwood 3125
Vic
Country 93156 0
Australia
Phone 93156 0
+61 03 92446944
Fax 93156 0
Email 93156 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
IPD will not be shared as it is not necessary for the analysis/interpretation of the results. However, we will share IPD with the editor/reviewers of the manuscript if requested.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2024Ethical approval    377524-(Uploaded-07-05-2019-18-09-52)-Study-related document.pdf
2025Informed consent form    377524-(Uploaded-07-05-2019-18-12-13)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AICarbohydrate Taste Is Associated with Food Intake and Body Mass in Healthy Australian Adults2021https://doi.org/10.3390/nu13113844
N.B. These documents automatically identified may not have been verified by the study sponsor.