Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000069954
Ethics application status
Approved
Date submitted
16/12/2019
Date registered
28/01/2020
Date last updated
27/05/2022
Date data sharing statement initially provided
28/01/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
A sensory study to analyse the differences of taste perception and physical sensory between food allergic and non-allergic individuals
Scientific title
A sensory study to analyse the differences of taste perception and physical sensory between food allergic and non-allergic individuals
Secondary ID [1] 300079 0
Nil known
Universal Trial Number (UTN)
U1111-1245-3273
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Food allergies 315599 0
Non-food allergy 315610 0
Condition category
Condition code
Inflammatory and Immune System 313904 313904 0 0
Allergies
Diet and Nutrition 313973 313973 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The trial requires participants to taste sample solutions (in water) of bitter, sweet, umami, fatty acid, salty and sour tastants, and taste (not eat nor drink) some hypoallergenic foods such as milk formulas to compare taste profiles (bitter intensity, sweet intensity, etc.) and tell investigators about their preference, flavour intensity and pleasantness. Each sample will not exceed 5 ml of solution. The volunteers are asked to taste the solution in a small sip and spit it out.
The total duration of observation per participant will be less than 2 hours.
Intervention code [1] 316360 0
Diagnosis / Prognosis
Intervention code [2] 316361 0
Early Detection / Screening
Comparator / control treatment
non-food allergy participants/group
Control group
Active

Outcomes
Primary outcome [1] 322293 0
Taste sensitivities (e.g. hypertaster, hypotaster, intensities rating).
Triple triangle test will be used for determining hypertasters and hypotasters: participants able to correctly identify the tastant solution sample three times will be classified as a high-sensitivity group (HS); while participants identifying at least one solution incorrectly will be classified as part of the low-sensitivity group (LS).
Intensities of each taste will be marked on a general Labelled Magnitude Scale (gLMS) which is anchored by the indicating descriptions from “barely detectable” to “weak”, “moderate”, strong”, “very strong” and “strongest imaginable”. The marks given by panellists on gLMS will be then converted in scores between 0 and 100 for analyses.
Timepoint [1] 322293 0
After checking the data collected in the sensory evaluations (within one day)
Primary outcome [2] 322294 0
Taste preference, pleasantness for hypoallergenic food.
Preference will be given by panelists on a questionnaire by comparing different hypoallergenic food products.
The pleasantness of the samples will be rated on a 9-point scale: “dislike extremely”, “dislike very much”, dislike moderately”, “dislike slightly”, “neither like nor dislike”, “like slightly”, “like moderately”, “like very much”, “like extremely”.
Timepoint [2] 322294 0
After checking the data collected in the sensory evaluations (within one day)
Secondary outcome [1] 377990 0
Taste/allergies-related genes expressions in blood cells.
RNA will be extracted from blood samples by professional kits and then analysed using qPCR and/or RNAseq.
Timepoint [1] 377990 0
12 months after the blood is taken (blood will be taken right after the sensory evaluations)
Secondary outcome [2] 377991 0
Taste/allergies-associated Single Nucleotide Polymorphisms (SNPs).
DNA will be extracted from blood samples by professional kits and then sent to the Australian Genome Research Facility (AGRF) for SNPs analyses.
Timepoint [2] 377991 0
12 months after the blood is taken (blood will be taken right after the sensory evaluations)
Secondary outcome [3] 377992 0
Peripheral blood mononuclear cells (PBMCs) will be harvested from the whole blood and Interleukin and Interferon analysing kits will be used to assess PBMCs activities.
Timepoint [3] 377992 0
12 months after the blood is taken (blood will be taken right after the sensory evaluations)

Eligibility
Key inclusion criteria
Non-food allergy individuals and food allergic individuals with a clinically diagnosed food allergy
Minimum age
7 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Those who are under medication (opioids, benzodiazepines, dihydropyridines, and antihistamines) and have health conditions, on-going allergic symptom(s) or smokers, pregnant or lactating females, have taste impairment.
Food allergy patients who are allergic to tastants used in sensory evaluations.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis
Based on statistical justification, 200 participants will be recruited (100 for the food allergic group and 100 for the non-food allergic group).
One way analysis of variance (ANOVA) was used to compare the taste intensity gLMS rankings of the seven taste compounds between cohorts. P values below 0.05 were considered significant. A mixed model analysis of variance will also be applied.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
24/05/2019
Date of last participant enrolment
Anticipated
30/09/2021
Actual
9/02/2021
Date of last data collection
Anticipated
31/12/2022
Actual
18/10/2021
Sample size
Target
200
Accrual to date
Final
200
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 28852 0
4215 - Southport
Recruitment postcode(s) [2] 28854 0
4072 - University Of Queensland
Recruitment postcode(s) [3] 29121 0
4006 - Newstead

Funding & Sponsors
Funding source category [1] 304525 0
University
Name [1] 304525 0
University research accounts of Eugeni Roura
Country [1] 304525 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Queensland Allergy Service
Address
5/123 Nerang St,
Southport QLD 4215, Australia
Country
Australia
Secondary sponsor category [1] 304797 0
Individual
Name [1] 304797 0
Walter Thomas
Address [1] 304797 0
Room 512, Sir William MacGregor Building [64],
The University of Queensland,
St Lucia, Queensland 4072, Australia
Country [1] 304797 0
Australia
Secondary sponsor category [2] 304805 0
Individual
Name [2] 304805 0
Raymond Steptoe
Address [2] 304805 0
University of Queensland Diamantina Institute,
The University of Queensland,
Woolloongabba, Queensland 4102, Australia
Country [2] 304805 0
Australia
Secondary sponsor category [3] 304809 0
Individual
Name [3] 304809 0
Peter Smith
Address [3] 304809 0
5/123 Nerang St, Queensland Allergy Service,
Southport QLD 4215, Australia
Country [3] 304809 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304959 0
University of Queensland Human Ethics Committee B
Ethics committee address [1] 304959 0
Ethics committee country [1] 304959 0
Australia
Date submitted for ethics approval [1] 304959 0
19/06/2018
Approval date [1] 304959 0
17/01/2019
Ethics approval number [1] 304959 0
2018001281

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

Contacts
Principal investigator
Name 98766 0
Prof Eugeni Roura
Address 98766 0
Room S403, Hartley Teakle Building [83],
Keyhole Rd, The University of Queensland,
St Lucia, Queensland 4072, Australia
Country 98766 0
Australia
Phone 98766 0
+61 7 3365 2526
Fax 98766 0
Email 98766 0
[email protected]
Contact person for public queries
Name 98767 0
Eugeni Roura
Address 98767 0
Room S403, Hartley Teakle Building [83],
Keyhole Rd, The University of Queensland,
St Lucia, Queensland 4072, Australia
Country 98767 0
Australia
Phone 98767 0
+61 7 3365 2526
Fax 98767 0
Email 98767 0
[email protected]
Contact person for scientific queries
Name 98768 0
Eugeni Roura
Address 98768 0
Room S403, Hartley Teakle Building [83],
Keyhole Rd, The University of Queensland,
St Lucia, Queensland 4072, Australia
Country 98768 0
Australia
Phone 98768 0
+61 7 3365 2526
Fax 98768 0
Email 98768 0
[email protected]

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6166Ethical approval  [email protected] 378927-(Uploaded-13-12-2019-12-08-45)-Study-related document.pdf
6167Informed consent form  [email protected] 378927-(Uploaded-13-12-2019-12-08-45)-Study-related document.doc



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.