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Trial registered on ANZCTR

Registration number

ACTRN12613000701729

Ethics application status

Approved

Date submitted

20/06/2013

Date registered

26/06/2013

Date last updated

29/09/2016

Type of registration

Prospectively registered

Titles & IDs

Public title

Determination of oral sweet taste function and its association with food consumption and Body Mass Index (BMI)

Scientific title

Determination of oral sweet taste function and its association with food consumption and Body Mass Index (BMI)

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

obesity

Condition category

Condition code

Diet and Nutrition

Obesity

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Participants in this project will be involved in various tests. Participants will be required to visit the Deakin University Sensory laboratory for at least 16 times (minimum of 2 visits per types of sugar/sweeteners). Subjects may experience:
Visit 1:
Food consumption and anthropometry. Participants will be asked to complete a Cancer Council food frequency questionnaire and a 7-day diet diary at home within 1 month of the sensory tests. Height, weight, waist and hip circumference will be measured at baseline. Weight and waist and hip circumference will be measured again at the end (final session).
Sweet taste receptors. Tongue swabs will be collected from participants to determine the sweet taste receptors.
Visits 1-2:
Determination of taste thresholds for the five basic tastes. Participants will be presented with a series of eight solutions for each tastants (sweet, sour, bitter, salty and umami), which will be arranged in ascending order of concentration. Participants will be asked to sample each solution, expel it after 10 seconds and then describe the taste of the solution. The process will be repeated twice (for visit 1-2) and will take approximately 1 hour 30 minutes for each visit.
Visits 3-4:
Suprathreshold (sufficient strength or quantity to produce a perceptible physiological effect) taste intensity perception for the five basic tastes.
Subjects will be given a brief training session in the use of gLMS (General Labelled Magnitude Scale) (in ascending order). gLMS is a scale consists of a vertical line, used to measure perceived taste intensity. To test for intensity perception of the five basic tastes, participants will be presented with numbered trays that contained 4 randomized solution for each taste quality. This will be repeated twice (for visits 3-4). Visits 3-4 will take about 50 minutes each, depending on their taste sensitivity.
Visits 5-6/ 7-8/ 9-10/ 11-12/ 13-14/ 15-16:
Taste thresholds for glucose, fructose, sucrose, sucralose, and Rebaudioside A (Stevia)
Each participant will be blinded (they will not know which sweetener/sugar they are tasting), and the order for tasting will be different for each participant.
Detection and threshold for sweeteners will be tested using ascending triangle forced-choice procedure. Participants will be provided with 3 samples (2 controls) per set, in ascending order from lowest to highest concentration. Following that, participants will be tested on their suprathreshold intensity perception for different kind of sweeteners/sugars. This procedure will be similar to the one described above (visits 3-4). Each visit will take about 20-40 minutes, depending on the sensitivity of the individual. Extra visits will be required if they were discrepancies (20-30% differences) between the results.
Each session will be separated by a minimum of a day.

Intervention code [1]

Not applicable

Comparator / control treatment

N/A

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Possible associations between sweet taste sensitivity (less sensitive or more sensitive), and its association with dietary consumption. Mean taste thresholds for glucose, fructose, sucrose, sucralose and Rebaudioside A will be determined. Correlations between mean thresholds with dietary consumption (from 7 day diet diary and Cancer Council Food frequency questionnaire) will be used to determine if there are any associations between sweet taste thresholds with food dietary consumption.

Timepoint [1]

Assessed once participants have completed the 16 visits.

Secondary outcome [1]

Possible associations between sweet taste sensitivity (less sensitive or more sensitive), and Body Mass Index (lean, healthy, overweight, obese). Mean taste thresholds for glucose, fructose, sucrose, sucralose, and Rebaudioside A will be determined. Correlations between mean thresholds with body mass index (anthropometry data will be measured on the first and final visit) will be used to determine if there are any associations between sweet taste thresholds with body mass index.

Timepoint [1]

Assessed once participants have completed the 16 visits.

Eligibility

Key inclusion criteria

over the age of 18 years of age

Minimum age

18 Years

Maximum age

85 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

smokers and BMI below 18 and above 35

Study design

Purpose

Natural history

Duration

Cross-sectional

Selection

Convenience sample

Timing

Prospective

Statistical methods / analysis

Information collected from participants will be used to:

1. Determine taste thresholds for glucose, fructose, sucrose, starch, sucralose and Rebaudioside A. Correlations between mean thresholds with BMI and food consumption (dietary pattern) will be used to determine if there are associations between sweet taste thresholds with food consumption and BMI.

2. Information concerning participant's food consumption and food behaviour will be used to evaluate differences between subject's thresholds.

3. Saliva samples will be taken to measure alpha amylase concentrations in the body to determine amylase activity.

Recruitment

Recruitment status

Active, not recruiting

Date of first participant enrolment

Anticipated

1/08/2013

Actual

16/09/2013

Date of last participant enrolment

Anticipated

31/12/2015

Actual

27/02/2015

Date of last data collection

Anticipated

Actual

Sample size

Target

100

Accrual to date

Final

100

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment postcode(s) [1]

3125 - Burwood

Recruitment postcode(s) [2]

3151 - Burwood East

Funding & Sponsors

Funding source category [1]

University

Name [1]

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

Address [1]

221 Burwood Highway
Burwood, 3125 VIC

Country [1]

Australia

Primary sponsor type

University

Name

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

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]

221 Burwood Highway, Burwood
VIC 3125

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

14/06/2013

Approval date [1]

10/09/2013

Ethics approval number [1]

Summary

Brief summary

Obesity is a major health issue that is currently affecting millions of Australians, in addition to having a high economic cost both in this country and around the world. Some individuals are more susceptible to obesity that others; one factor may be variance in taste system due to genetic and environmental factors such as diet. The present study aims to identify and investigate the associations between individual differences in sweet and carbohydrate taste sensitivity with diet and BMI. 

Proposal research design and methods:
The study will involve 100 subjects. These participants will be over 18 years of age and within a BMI range of 18-35kg/m2. Participation in this study involves attending at least 16 laboratory sessions. The first three sessions will involve taste function assessment of the five basic taste qualities (Sweet, sour, bitter, salty and umami). The remaining sessions will involve taste function assessment for different kinds of sugars, natural sweeteners and artificial sweeteners. Participants will be given a copy of the Cancer Council Food Frequency Questionnaire and a 7-day diet diary at baseline, and will be asked to complete them within one month of the sensory testing period. Subject's height, hip and waist circumference, and tongue swab for cell collection will be collected at baseline. Subject's weight will be measured twice, at baseline and at the final visit. 

The study will use a range of methods and will take place in Deakin University sensory laboratories. Sensory evaluations, including ascending detection and recognition thresholds (sample a series of eight solutions arranged in ascending order to determine taste thresholds) and ascending forced-choice test (correctly choosing a sample that has added sugars/sweeteners/starch at specific concentration) will be used to determine sweet and carbohydrate taste function.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Russell Keast

Address

Centre of Advanced Sensory Science/ School of Exercise and Nutrition Sciences, Deakin University, 221, Burwood Highway, Burwood, 3125, VIC

Country

Australia

Phone

+61 3 92446944

Fax

[email protected]

Contact person for public queries

Name

Julia Low

Address

Centre of Advanced Sensory Science/ School of Exercise and Nutrition Sciences, Deakin University
221 Burwood Highway, Burwood, 3125, VIC

Country

Australia

Phone

+61 3 92446017

Fax

[email protected]

Contact person for scientific queries

Name

Russell Keast

Address

Centre of Advanced Sensory Science/ School of Exercise and Nutrition Sciences, Deakin University
221 Burwood Highway, Burwood, 3125, VIC

Country

Australia

Phone

+61 3 92446944

Fax

[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

Source	Title	Year of Publication	DOI
Embase	The association between sweet taste function, anthropometry, and dietary intake in adults.	2016	https://dx.doi.org/10.3390/nu8040241
Dimensions AI	Psychophysical Evaluation of Sweetness Functions Across Multiple Sweeteners	2016	https://doi.org/10.1093/chemse/bjw109
Dimensions AI	The impact of dietary protein: lipid ratio on growth performance, fatty acid metabolism, product quality and waste output in Atlantic salmon (Salmo salar)	2019	https://doi.org/10.1016/j.aquaculture.2018.11.012

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

Trial Review

Documents added manually

Documents added automatically