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Trial registered on ANZCTR
Registration number
ACTRN12619000668101
Ethics application status
Approved
Date submitted
30/04/2019
Date registered
3/05/2019
Date last updated
3/05/2019
Date data sharing statement initially provided
3/05/2019
Date results information initially provided
3/05/2019
Type of registration
Retrospectively registered
Titles & IDs
Public title
The effect of a milk-based oral rinse on satiety
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Scientific title
The effect of oral exposure to a milk-based fatty acid solution on self-reported satiety ratings in healthy Australian adults
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Secondary ID [1]
298102
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Obesity
312623
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Satiety
312624
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Condition category
Condition code
Diet and Nutrition
311123
311123
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0
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Obesity
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment is a 30 second oral rinse of a 20 mM oleic acid solution in skim milk. Treatment is provided on two separate days and placebo on another two separate days, in a random order. The washout period between treatments and/or placebos is at least 24 hours.
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Intervention code [1]
314330
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Treatment: Other
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Comparator / control treatment
A 30 second oral rinse of skim milk (with no oleic acid)
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Self-reported satiety ratings measured on 100 mm digital visual analogue scales using the computer software Compusense Cloud.
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Assessment method [1]
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Timepoint [1]
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Every 30 minutes for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes)
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Secondary outcome [1]
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Oleic acid taste sensitivity assessed using a 3-alternate forced choice triangle test, where three sample sets of milk are served to the participant. For each set, two samples are control samples and one sample contains oleic acid.
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Assessment method [1]
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Timepoint [1]
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Every hour for 3 hours (0, 60, 120, 180 minutes)
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Eligibility
Key inclusion criteria
Aged between 18-50 years; able to attend four laboratory testing sessions in the CASS lab at Deakin University; willing to fast overnight prior to each testing session; willing to consume milk and wheat products
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Minimum age
18
Years
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Maximum age
50
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Allergic or intolerant to wheat or dairy; smoker; non-fluent in English; pregnant or lactating; on a diet that restricted energy consumption; had an illness or condition that precluded them from fasting overnight (e.g. diabetes mellitus)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was concealed using numbered medicine cups containing either the treatment solution or placebo
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software prior to recruitment of participants. Participants were were allocated to the randomisation table in order of recruitment date.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
The effect of oleic acid oral exposure on satiety ratings will be assessed using linear mixed models including time (-30 minutes to 180 minutes), treatment (treatment or placebo), time-treatment interaction and day of testing as fixed effects; and participant as the subject with repeated measures. The same analysis will be conducted to assess the effect of oleic acid oral exposure on oleic acid taste sensitivity. Post-hoc Sidak’s P-values and confidence intervals will be reported.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
3/12/2018
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Date of last participant enrolment
Anticipated
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Actual
7/03/2019
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Date of last data collection
Anticipated
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Actual
17/04/2019
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Sample size
Target
30
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Accrual to date
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Final
31
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment postcode(s) [1]
26355
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3125 - Burwood
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Centre for Advanced Sensory Science
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Address [1]
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Deakin University
Centre for Advanced Sensory Science
School of Exercise and Nutrition Sciences
221 Burwood Hwy, Burwood, 3125, VIC
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Country [1]
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Australia
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Primary sponsor type
Individual
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Name
Professor Russell Keast
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Address
Deakin University
Centre for Advanced Sensory Science
School of Exercise and Nutrition Sciences
221 Burwood Hwy, 3125, VIC
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
302548
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Country [1]
302548
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Deakin University Faculty of Health Human Ethics Advisory Group
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Ethics committee address [1]
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Deakin University
Faculty of Health
221 Burwood Hwy, Burwood, 3125, VIC
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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30/10/2018
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Approval date [1]
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29/11/2018
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Ethics approval number [1]
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HEAG-H 182_2018
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Summary
Brief summary
Acute exposure to fatty acid in the oral cavity leads to a satiety response (both hormonal and behavioural) in rodent models. However, this has never been shown in human studies. In addition, there is a large variation in taste sensitivity to fatty acid among humans. Therefore, it is possible that variation in fatty acid taste sensitivity might influence the efficacy of a fatty acid-mediated satiety response.
The primary aim of this study was to assess whether oral exposure to a high concentration fatty acid solution would affect satiety in healthy Australian adults. The secondary aim was to assess whether fatty acid taste sensitivity would modify the aforementioned effect.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Andrew Costanzo
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Address
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Deakin University
Centre for Advanced Sensory Science
School of Exercise and Nutrition Sciences
221 Burwood Hwy, Burwood, 3125, VIC
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Country
93054
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Australia
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Phone
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+61 3 9246 8207
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Prof Russell Keast
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Address
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Deakin University
Centre for Advanced Sensory Science
School of Exercise and Nutrition Sciences
221 Burwood Hwy, Burwood, 3125, VIC
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Country
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Australia
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Phone
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+61 3 9244 6944
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Fax
93055
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Email
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[email protected]
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Contact person for scientific queries
Name
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Prof Russell Keast
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Address
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Deakin University
Centre for Advanced Sensory Science
School of Exercise and Nutrition Sciences
221 Burwood Hwy, Burwood, 3125, VIC
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Country
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Australia
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Phone
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+61 3 9244 6944
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Fax
93056
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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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.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
1959
Informed consent form
377499-(Uploaded-30-04-2019-12-34-41)-Study-related document.docx
1960
Ethical approval
377499-(Uploaded-30-04-2019-12-34-57)-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
Source
Title
Year of Publication
DOI
Embase
A fatty acid mouth rinse decreases self-reported hunger and increases self-reported fullness in healthy Australian adults: A randomized cross-over trial.
2020
https://dx.doi.org/10.3390/nu12030678
N.B. These documents automatically identified may not have been verified by the study sponsor.
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