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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
Scientific title
The effect of oral exposure to a milk-based fatty acid solution on self-reported satiety ratings in healthy Australian adults
Secondary ID [1] 298102 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 312623 0
Satiety 312624 0
Condition category
Condition code
Diet and Nutrition 311123 311123 0 0
Obesity

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 314330 0
Treatment: Other
Comparator / control treatment
A 30 second oral rinse of skim milk (with no oleic acid)
Control group
Placebo

Outcomes
Primary outcome [1] 319896 0
Self-reported satiety ratings measured on 100 mm digital visual analogue scales using the computer software Compusense Cloud.
Timepoint [1] 319896 0
Every 30 minutes for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes)
Secondary outcome [1] 369816 0
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.
Timepoint [1] 369816 0
Every hour for 3 hours (0, 60, 120, 180 minutes)

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
Minimum age
18 Years
Maximum age
50 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
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)

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 numbered medicine cups containing either the treatment solution or placebo
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.
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)
Efficacy
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 26355 0
3125 - Burwood

Funding & Sponsors
Funding source category [1] 302636 0
University
Name [1] 302636 0
Centre for Advanced Sensory Science
Address [1] 302636 0
Deakin University
Centre for Advanced Sensory Science
School of Exercise and Nutrition Sciences
221 Burwood Hwy, Burwood, 3125, VIC
Country [1] 302636 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, 3125, VIC
Country
Australia
Secondary sponsor category [1] 302548 0
None
Name [1] 302548 0
Address [1] 302548 0
Country [1] 302548 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303262 0
Deakin University Faculty of Health Human Ethics Advisory Group
Ethics committee address [1] 303262 0
Deakin University
Faculty of Health
221 Burwood Hwy, Burwood, 3125, VIC
Ethics committee country [1] 303262 0
Australia
Date submitted for ethics approval [1] 303262 0
30/10/2018
Approval date [1] 303262 0
29/11/2018
Ethics approval number [1] 303262 0
HEAG-H 182_2018

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93054 0
Dr Andrew Costanzo
Address 93054 0
Deakin University
Centre for Advanced Sensory Science
School of Exercise and Nutrition Sciences
221 Burwood Hwy, Burwood, 3125, VIC
Country 93054 0
Australia
Phone 93054 0
+61 3 9246 8207
Fax 93054 0
Email 93054 0
andrew.costanzo@deakin.edu.au
Contact person for public queries
Name 93055 0
Prof Russell Keast
Address 93055 0
Deakin University
Centre for Advanced Sensory Science
School of Exercise and Nutrition Sciences
221 Burwood Hwy, Burwood, 3125, VIC
Country 93055 0
Australia
Phone 93055 0
+61 3 9244 6944
Fax 93055 0
Email 93055 0
russell.keast@deakin.edu.au
Contact person for scientific queries
Name 93056 0
Prof Russell Keast
Address 93056 0
Deakin University
Centre for Advanced Sensory Science
School of Exercise and Nutrition Sciences
221 Burwood Hwy, Burwood, 3125, VIC
Country 93056 0
Australia
Phone 93056 0
+61 3 9244 6944
Fax 93056 0
Email 93056 0
russell.keast@deakin.edu.au

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?
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 1959 0
Informed consent form
Citation [1] 1959 0
Link [1] 1959 0
Email [1] 1959 0
Other [1] 1959 0
Type [2] 1960 0
Ethical approval
Citation [2] 1960 0
Link [2] 1960 0
Email [2] 1960 0
Other [2] 1960 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary