ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12619000713190

Ethics application status

Approved

Date submitted

8/05/2019

Date registered

13/05/2019

Date last updated

22/04/2020

Date data sharing statement initially provided

13/05/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Investigating the influence of an oral rinse intervention, containing a taste stimuli, on participants taste perception/sensitivity.

Scientific title

Oral Rinse Intervention Study, investigating changes in detection and recognition threshold and suprathreshold intensity perception following an oral rinse containing specific tastants in generally healthy participants.

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

ORIS

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Taste sensitivity

Condition category

Condition code

Oral and Gastrointestinal

Normal oral and gastrointestinal development and function

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Participants will be completing four, 2-week oral rinse interventions, where they are required to rinse their mouth out with 30ml of a food grade solution, 3 times a day (directly after breakfast, lunch and dinner), for 30 seconds, participants will be instructed not to swallow the solution.
In a randomised, cross-over intervention design participants will be exposed to all four interventions in a uniquely randomised order, with a 3-week washout between each oral rinse intervention. Participants will be sent via text or email a link to a compliance survey where they will be required to record all rinses completed on that day, or any rinses missed on that day, this will be sent out between 7-8.30pm daily.
The rinses include:
- 400 mM Monopotassium Glutamate
- 400 mM Monosodium Glutamate
- 400 mM sucrose
- 400 mM sodium chloride

Participants will be provided with the solutions for the two weeks and will be instructed to keep the solutions in the fridge for the duration of the intervention, once the intervention has been completed participants can dispose of the bottles as required. Participants will complete the oral rinse intervention at home/away from the research facility.

Intervention code [1]

Other interventions

Comparator / control treatment

There is no control intervention, due to the nature of the balanced, randomised, cross-over intervention design, participants will be their own control, and thus no control intervention rinse will be applied.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Change in taste sensitivity (mM) for detection threshold (DT) and recognition threshold (RT), this is measured following ISO - Method of Investigating sensitivity of taste (ISO 3972:1991).

Timepoint [1]

After two weeks of the intervention

Primary outcome [2]

Change in taste intensity perception, on 100 point vertical line scale (Labelled Magnitude Scale).

Timepoint [2]

After two weeks of the intervention

Secondary outcome [1]

Change in umami discrimination status, based on number of correct answers in a discrimination task, this discrimination task requires participants to taste three samples containing 29mM MSG or 29mM NaCl and choose the sample that is different, this is repeated 24 times as per previously published methodology (Lugaz O1, Pillias AM, Faurion A. Chem Senses. A new specific ageusia: some humans cannot taste L-glutamate. 2002 Feb;27(2):105-15).

Timepoint [1]

After two weeks of the intervention

Eligibility

Key inclusion criteria

Any participant, provided they do not meet any of the exclusion criteria.

Minimum age

18 Years

Maximum age

50 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

- non smoker
- not currently pregnant
- no allergies to the food grade chemicals in the rinse
- no known taste impairments

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 not concealed, participants allocate to the next available intervention order.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Randomisation generated in consultation with a statistician using simple randomisation for example from a statistics book to ensure all possible orders obtained, due to four interventions, there are 24 possible orders for a balanced design.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Crossover

Other design features

A balanced, cross-over intervention design will be followed.

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Active, not recruiting

Date of first participant enrolment

Anticipated

15/05/2019

Actual

20/05/2019

Date of last participant enrolment

Anticipated

10/07/2019

Actual

15/11/2019

Date of last data collection

Anticipated

15/12/2020

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment postcode(s) [1]

3125 - Burwood

Funding & Sponsors

Funding source category [1]

University

Name [1]

Deakin University, Centre for Advanced Sensory Science

Address [1]

221 Burwood highway, Burwood, VIC, 3125

Country [1]

Australia

Primary sponsor type

University

Name

Deakin University, School of Exercise and Nutrition Sciences, Centre for Advanced Sensory Science.

Address

221 Burwood highway, Burwood, VIC, 3125

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Deakin University Human Research Ethics Committee

Ethics committee address [1]

Locked Bag 20000, Geelong, VIC 3220

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

18/03/2019

Approval date [1]

02/05/2019

Ethics approval number [1]

2019-094

Summary

Brief summary

Investigating factors that influence taste perception provides an insight why individuals may over consume certain foods. There are a number of factors which influence taste perception, including environmental (dietary) and genetic factors. In this study we will be investigating the influence of frequent oral (mouth) exposure to certain taste stimuli on taste perception. As certain genes have been found to be associated with individual differences in taste perception, it is also of interest to investigate the role genetics has in taste perception particularly following oral exposure to certain taste stimuli. It is hypothesised that oral exposure to certain tastants will reduce participants taste sensitivity, that is make them less sensitive, to that specific tastant.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Russell Keast

Address

Deakin University, 221 Burwood Highway, Burwood, VIC, 3125

Country

Australia

Phone

+61 3 924 46944

Fax

russell.keast@deakin.edu.au

Contact person for public queries

Name

Isabella Hartley

Address

Deakin University, 221 Burwood Highway, Burwood, VIC, 3125

Country

Australia

Phone

+61409891681

Fax

iehartle@deakin.edu.au

Contact person for scientific queries

Name

Russell Keast

Address

Deakin University, 221 Burwood Highway, Burwood, VIC, 3125

Country

Australia

Phone

+61 3 924 46944

Fax

russell.keast@deakin.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

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

Source	Title	Year of Publication	DOI
Embase	Oral Exposure to Sodium Chloride without Subsequent Consumption Does Not Alter Salt Taste Function in Adults: A Cross-Over Intervention Study.	2023	https://dx.doi.org/10.1016/j.tjnut.2022.12.010

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically