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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] 282709 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 289423 0
Condition category
Condition code
Diet and Nutrition 289756 289756 0 0
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] 287370 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289838 0
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] 289838 0
Assessed once participants have completed the 16 visits.
Secondary outcome [1] 303356 0
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] 303356 0
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
Gender
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
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] 6990 0
3125 - Burwood
Recruitment postcode(s) [2] 6991 0
3151 - Burwood East

Funding & Sponsors
Funding source category [1] 287480 0
University
Name [1] 287480 0
Centre of Advanced Sensory Science/ School of Exercise and Nutrition Sciences, Deakin University
Address [1] 287480 0
221 Burwood Highway
Burwood, 3125 VIC
Country [1] 287480 0
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] 286222 0
None
Name [1] 286222 0
Address [1] 286222 0
Country [1] 286222 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289458 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 289458 0
221 Burwood Highway, Burwood
VIC 3125
Ethics committee country [1] 289458 0
Australia
Date submitted for ethics approval [1] 289458 0
14/06/2013
Approval date [1] 289458 0
10/09/2013
Ethics approval number [1] 289458 0

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 40930 0
Prof Russell Keast
Address 40930 0
Centre of Advanced Sensory Science/ School of Exercise and Nutrition Sciences, Deakin University, 221, Burwood Highway, Burwood, 3125, VIC
Country 40930 0
Australia
Phone 40930 0
+61 3 92446944
Fax 40930 0
Email 40930 0
russell.keast@deakin.edu.au
Contact person for public queries
Name 40931 0
Miss Julia Low
Address 40931 0
Centre of Advanced Sensory Science/ School of Exercise and Nutrition Sciences, Deakin University
221 Burwood Highway, Burwood, 3125, VIC
Country 40931 0
Australia
Phone 40931 0
+61 3 92446017
Fax 40931 0
Email 40931 0
yqlow@deakin.edu.au
Contact person for scientific queries
Name 40932 0
Prof Russell Keast
Address 40932 0
Centre of Advanced Sensory Science/ School of Exercise and Nutrition Sciences, Deakin University
221 Burwood Highway, Burwood, 3125, VIC
Country 40932 0
Australia
Phone 40932 0
+61 3 92446944
Fax 40932 0
Email 40932 0
russell.keast@deakin.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary