Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000560291
Ethics application status
Approved
Date submitted
3/04/2018
Date registered
13/04/2018
Date last updated
13/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of a carbohydrate oral rinse on energy expenditure in a fed state in individuals with high and low sensitivity to carbohydrate taste
Scientific title
The effect of carbohydrate taste stimulation on energy utilisation in a fed state in individuals hypersensitive and hyposensitive to carbohydrate taste
Secondary ID [1] 294488 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relationship between taste and energy use 307256 0
Condition category
Condition code
Oral and Gastrointestinal 306376 306376 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Twenty participants will complete a randomised crossover study that investigates participants’ energy expenditure and substrate (carbohydrate and fat) oxidation after drinking a beverage containing 50g of maltodextrin followed by sensory stimulation with a maltodextrin, glucose or water (control) solution. There will be 3 x 3 hour test sessions in total for each participant, with a washout period of at least 3 days. Test sessions will take place in Deakin University's clinical laboratories. Measurements will be taken at approximately the same time for all 3 test sessions. Participants will be asked to adhere to the following guidelines the day before test sessions: eat a dinner that is the type and amount they would usually eat, keep their usual physical activity level, avoid high intensity exercise, and fast overnight (8-12 hours).

On the day of test sessions, participants will arrive after their overnight fast, voided urine. They will first undertake anthropometry measurements. Body weight and composition will be measured using a body composition analyser (Tanita BC-418). Height will be measured using a portable stadiometer. They will then rest for 30 minutes before having their REE measured using an indirect calorimeter (Quark RMR). The measurement involves the placement of a transparent hood over the upper body of participants, which is connected to gas analysers that measure oxygen consumption and carbon dioxide production. Following this, participants will drink a carbohydrate drink containing 50 g of maltodextrin within 3 minutes. This will be immediately followed by oral stimulation with a maltodextrin solution (carbohydrate taste), glucose solution (sweet taste) or de-ionised water (control) using the “sip and spit” method for 45 seconds. Gaseous exchanges will be measured for the next 90 minutes to determine energy expenditure and substrate oxidation using the hooded indirect calorimeter. Participants are allowed to watch the television during the measurement. A researcher will be present at all times during the test session in order to monitor adherence to the intervention. The indirect calorimeter will be calibrated prior to each test session to ensure accuracy of readings. Respiratory quotient (RQ) will be calculated as a ratio of carbon dioxide production to oxygen consumption. Oxygen consumption and carbon dioxide production will be used to calculate energy expenditure using Weir equation and substrate oxidation (carbohydrate and fat) rates using Frayn equations.
Intervention code [1] 300785 0
Treatment: Other
Comparator / control treatment
As this is a crossover study, participants will act as their own control. De-ionised water will be the control oral rinse.
Control group
Active

Outcomes
Primary outcome [1] 305387 0
Postprandial energy expenditure (EE) assessed by the measurement of carbon dioxide produced and oxygen consumed using an indirect calorimeter in order to calculate EE in kcal/day.
Timepoint [1] 305387 0
Assessed at a single timepoint at completion of all 3 test sessions.
Primary outcome [2] 305436 0
Substrate utilisation assessed by the measurement of carbon dioxide produced and oxygen consumed using an indirect calorimeter in order to calculate respiratory quotient.
Timepoint [2] 305436 0
Assessed at a single timepoint at completion of all 3 test sessions.
Secondary outcome [1] 345037 0
Carbohydrate taste sensitivity as determined by suprathreshold measurements.
Timepoint [1] 345037 0
Baseline.

Eligibility
Key inclusion criteria
18 years or over
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Impaired smell or taste function, claustrophobia, pregnancy, metabolic diseases (e.g. cardiovascular disease, diabetes), smoker, weight gain or loss >5 kg in past 3 months.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/04/2018
Actual
Date of last participant enrolment
Anticipated
15/06/2018
Actual
Date of last data collection
Anticipated
29/06/2018
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 299113 0
University
Name [1] 299113 0
Centre for Advanced Sensory Science, School of Exercise and Nutrition Sciences, Deakin University
Country [1] 299113 0
Australia
Primary sponsor type
University
Name
Centre for Advanced Sensory Science, School of Exercise and Nutrition Sciences, Deakin University
Address
221 Burwood Highway
Burwood
VIC 3125
Country
Australia
Secondary sponsor category [1] 298371 0
None
Name [1] 298371 0
Address [1] 298371 0
Country [1] 298371 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300046 0
Deakin University Human Ethics Advisory Group Health (HEAG-H)
Ethics committee address [1] 300046 0
Ethics committee country [1] 300046 0
Australia
Date submitted for ethics approval [1] 300046 0
23/01/2018
Approval date [1] 300046 0
20/02/2018
Ethics approval number [1] 300046 0
HEAG-H 09_2018

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

Contacts
Principal investigator
Name 82378 0
Prof Russell Keast
Address 82378 0
Centre for Advanced Sensory Science
School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Highway
Burwood, VIC 3125
Country 82378 0
Australia
Phone 82378 0
+61 3 92446944
Fax 82378 0
Email 82378 0
[email protected]
Contact person for public queries
Name 82379 0
Zoe Liaw
Address 82379 0
Centre for Advanced Sensory Science
School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Highway
Burwood, VIC 3125
Country 82379 0
Australia
Phone 82379 0
+61 3 92446944
Fax 82379 0
Email 82379 0
[email protected]
Contact person for scientific queries
Name 82380 0
Russell Keast
Address 82380 0
Centre for Advanced Sensory Science
School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Highway
Burwood, VIC 3125
Country 82380 0
Australia
Phone 82380 0
+61 3 92446944
Fax 82380 0
Email 82380 0
[email protected]

No information has been provided regarding IPD availability


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.