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Trial registered on ANZCTR


Registration number
ACTRN12620000125921p
Ethics application status
Submitted, not yet approved
Date submitted
17/01/2020
Date registered
11/02/2020
Date last updated
11/02/2020
Date data sharing statement initially provided
11/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Using a mouth rinse to suppress acute appetite and ad libitum food intake
Scientific title
Using a fatty-acid based mouth wash to suppress acute appetite and ad libitum food intake in healthy Australian adults
Secondary ID [1] 300294 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Appetite suppression 315884 0
Condition category
Condition code
Diet and Nutrition 314161 314161 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The treatment is a 30 second mouth rinse of a solution containing 20 mM of oleic acid. The treatment will be provided as a single dose 90 minutes prior to the outcome measures.
Washout period between treatments/control treatments will be 7 days.
The treatment will be timed and observed by researchers to ensure that participants adhere to the entire mouth rinse protocol.
Intervention code [1] 316569 0
Prevention
Comparator / control treatment
Two control groups:
Positive control: Same solution as above with isocaloric amount of vegetable oil instead of oleic acid
Negative control: Same solution but without added fat/fatty acid
Control group
Placebo

Outcomes
Primary outcome [1] 322545 0
An ad libitum food intake of an all-you-can-eat lunch will be used to assess acute dietary intake. Plates containing food will be weighed using scales before and after being served to participants to calculated the quantity of food consumed. Total energy intake (kJ) and macronutrient intake (grams and % of energy) will be assessed using FoodWorks software.
Timepoint [1] 322545 0
Lunch will commence 90 minutes following treatment, with a maximum duration of 45 minutes. Therefore, the timepoint will be 90-135 minutes.
Secondary outcome [1] 378895 0
A self-reported satiety questionnaire will be completed on a digital 100 mm visual analogue scale using Compusense Cloud software. This is to validate that the participants eat until they are comfortably full.
Timepoint [1] 378895 0
Questionnaire will be completed prior to lunch (90 following treatment) and after lunch (135 minutes following treatment).

Eligibility
Key inclusion criteria
Ages 18-55 years, speaks fluent English, healthy
Minimum age
18 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Smoker, pregnant or lactating, allergic to foods that are served, restricted eater (as determined by the Three Factor Eating Questionnaire), adhering to a restrictive diet, dietary requirements or illnesses that prevents or interferes with eating (eg, Crohn's disease, diabetes).

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)
Containers that are numbered with blinding codes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by Microsoft Excel
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering 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
Sample size was determined to be n=40 calculation based on pilot data. Linear mixed models will be employed to compare the efficacy of the treatment compared to the controls.

Recruitment
Recruitment status
Not yet recruiting
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] 29030 0
3125 - Burwood

Funding & Sponsors
Funding source category [1] 304718 0
University
Name [1] 304718 0
Deakin University - School of Exercise and Nutrition Sciences
Address [1] 304718 0
Deakin University
221 Burwood Hwy, Burwood, VIC, 3125
Country [1] 304718 0
Australia
Primary sponsor type
Individual
Name
Dr Andrew Costanzo
Address
School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Hwy, Burwood, VIC, 3125
Country
Australia
Secondary sponsor category [1] 305033 0
University
Name [1] 305033 0
Deakin University - CASS Food Research Centre
Address [1] 305033 0
Deakin University
School of Exercise and Nutrition Sciences
221 Burwood Hwy, Burwood, VIC, 3125
Country [1] 305033 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305143 0
Deakin University Human Ethics Advisory Group
Ethics committee address [1] 305143 0
Deakin University
School of Exercise and Nutrition Sciences
221 Burwood Hwy
Burwood, VIC, 3125
Ethics committee country [1] 305143 0
Australia
Date submitted for ethics approval [1] 305143 0
17/01/2020
Approval date [1] 305143 0
Ethics approval number [1] 305143 0

Summary
Brief summary
Forty healthy adult subjects will be recruited to attend three data collection sessions at the CASS labs at Deakin University Burwood Campus. During any session, participants will be provided with any one mouth rinse in a random order: containing fatty acid (oleic acid 20mM), containing triglyceride (vegetable oil isocaloric to the fatty acid wash; positive control), or containing neither (negative control). They will then return to the lab after 90 minutes for an ad libitum buffet lunch, where they will be able to consume as much or as little food as they like. Food intake will be measured to assess the effect of the mouth rinse on intake. Participants will return to the CASS lab on separate days to complete the same methods, but with the other two remaining mouth rinses (cross-over design).

Data will be collected via the researcher weighing food and plates to calculate the exact quantity of food intake. This will be performed in a separate room to the buffet to ensure there is no influence on the participants.

Additional measures:
• Participants will keep a food record of their intake on the morning of each session. This will be completed using an online tool – ASA24 Australia
• Participants will complete satiety questionnaires before and after lunch to ensure they are comfortably full following buffet. These will be completed using an online survey software – Compusense Cloud

The aim is to assess the effects of a fatty acid-based mouth rinse on acute appetite and ad libitum food intake. We hypothesise that the fatty acid-based mouth rinse will reduce food intake compared to a control rinse.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99386 0
Dr Andrew Costanzo
Address 99386 0
Deakin University
School of Exercise and Nutrition Sciences
221 Burwood Hwy, Burwood, VIC, 3125
Country 99386 0
Australia
Phone 99386 0
+61 03 9246 8207
Fax 99386 0
Email 99386 0
andrew.costanzo@deakin.edu.au
Contact person for public queries
Name 99387 0
Dr Andrew Costanzo
Address 99387 0
Deakin University
School of Exercise and Nutrition Sciences
221 Burwood Hwy, Burwood, VIC, 3125
Country 99387 0
Australia
Phone 99387 0
+61 03 9246 8207
Fax 99387 0
Email 99387 0
andrew.costanzo@deakin.edu.au
Contact person for scientific queries
Name 99388 0
Dr Andrew Costanzo
Address 99388 0
Deakin University
School of Exercise and Nutrition Sciences
221 Burwood Hwy, Burwood, VIC, 3125
Country 99388 0
Australia
Phone 99388 0
+61 03 9246 8207
Fax 99388 0
Email 99388 0
andrew.costanzo@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
What supporting documents are/will be available?
No other documents available
Summary results
No Results