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Trial registered on ANZCTR

Registration number

ACTRN12616001356459

Ethics application status

Approved

Date submitted

2/07/2015

Date registered

29/09/2016

Date last updated

29/09/2016

Type of registration

Retrospectively registered

Titles & IDs

Public title

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

Scientific title

Carbohydrate taste sensitivity testing in healthy volunteers to determine human oral carbohydrate taste function and its association with food consumption and BMI

Secondary ID [1]

NIL

Universal Trial Number (UTN)

NIL

Trial acronym

NIL

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 will be required to visit the Centre of Advanced Sensory Science laboratory, Deakin University for at least 17 times (maximum of 7 times per types of carbohydrate).

Participants may experience:
Visit 1:
Food consumption and anthropometry. Participants will be asked to complete a Cancer Council food frequency questionnaire, a 4-day diet diary, and a 3-factor eating questionnaire at home within 1 month of the sensory tests. Height, weight, waist circumference will be measured at baseline. Weight and waist circumference will be measured again at the end (final session).

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:
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 (bitter, salty, sweet, sour, umami), participants will be presented with numbered trays that contained 4 randomized solution for each taste quality (15mL each). Participants were instructed to held in each of the solutions in the mouth for at least five seconds and expectorate. Participants were then required to rate the taste intensity perception on a computerised gLMS. Participants were also instructed to rinse their mouth for five seconds with filtered deionised water between samples. Solutions will be presented in randomised order. The minimum and maximum concentrations of solutions will range from 0.04g/L-63.1g/L

This will be repeated twice (for visit 3). Visit 3 will take about 50 minutes, depending on their taste sensitivity.

Visits 4-10; 11-17:
Detection thresholds for maltodextrin and inulin.
Each participant will be blinded (they will not know which carbohydrate they are tasting). Detection thresholds for carbohydrates (maltodextrin, inulin) will be tested using ascending triangle forced-choice procedure. Participants will be provided with three 25 mL samples: two controls (filtered deionised water solutions) and one containing carbohydrate (maltodextrin or inulin), per set, in ascending order from the lowest to the highest concentration. Participants were instructed to rinse their mouths for five seconds with filtered deionised water before beginning the task and between each sample set. Detection thresholds for each sweetener or polysaccharides was defined as the concentration of carbohydrate required for a participant to correctly identify the sweetened or polysaccharide sample as ‘odd’ from the two control samples, in three consecutive sample sets at one concentration level (Meilgaard et al., 2007).

Each visit will take about 10-20 minutes, depending on the sensitivity of the individual.
Each session will be separated by a minimum of 1 hour. The minimum and maximum concentration of solutions will range from 0.04g/l-63.1g/L

Intervention code [1]

Not applicable

Comparator / control treatment

nil

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Possible associations between carbohydrate taste sensitivity (less sensitive or more sensitive), and its association with dietary consumption.
Mean taste thresholds for carbohydrates 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 carbohydrate taste thresholds with food dietary consumption.

Timepoint [1]

Assessed once participants have completed the 17 visits

Secondary outcome [1]

Possible associations between carbohydrate taste sensitivity (less sensitive or more sensitive), and its association with body mass index.
Mean taste thresholds for carbohydrates will be determined. Correlations between mean thresholds with body mass index (anthropometry measurements- heigh, weight, and waist circumference) will be used to determine if there are any associations between carbohydrate taste thresholds with body mass index.

Timepoint [1]

Assesed once participants have completed the 17 visits.

Eligibility

Key inclusion criteria

over the age of 18 years of age and below the age of 85 years.

Minimum age

18 Years

Maximum age

85 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

smokers, pregnant or lactating, known allergies towards any food used in the study to assess taste thresholds

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. A sample size of 30 participants was chosen in line with the central limits theorem to approximate a normal population distribution (Field, 2009).

2. Determine taste thresholds for carbohydrates (inulin and maltodextrin). Correlations between mean thresholds with BMI and food consumption (dietary pattern) will be used to determine if there are associations between carbohydrate taste thresholds with food consumption and BMI.

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

Recruitment

Recruitment status

Active, not recruiting

Date of first participant enrolment

Anticipated

Actual

2/03/2015

Date of last participant enrolment

Anticipated

30/09/2015

Actual

Date of last data collection

Anticipated

29/02/2016

Actual

26/02/2016

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]

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

Address [1]

221, Burwood Highway, 3125, Burwood, 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 Ethics Advisory Group (HEAG)

Ethics committee address [1]

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

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

27/10/2014

Approval date [1]

06/11/2014

Ethics approval number [1]

HEAG-H 182_2014

Summary

Brief summary

The aim of this project is to investigate if humans are able to detect small amounts of carbohydrate orally and investigate links with dietary consumption and weight. Over the past decades, behavioural studies demonstrated that rats are very attracted to starch and that starch is preferred to sucrose at low concentrations, suggesting that rats have different taste receptors for sucrose and starch. Carbohydrates, in the form of sugar and starch, represent a major source of food energy. Except for some fruits, plants contain much more starch than sugar, but it is sugar with its sweet taste that is the most sought after carbohydrate. Compared to sugar, starch is rather bland to the human palate, and has been assumed to be tasteless for other animals as well. However, in the past decades, studies using animal models reported that rats are very attracted to the taste of maltodextrin (starch). The results of these studies suggest that starch and sucrose stimulate different taste qualities, indicating there is an independent taste receptor for polysaccharides. 

Recent studies investigating carbohydrate sensing in the human oral cavity through exercise performance have also found that exercise performance significantly improved after participants rinsed their mouth with solutions containing maltodextrin (see review by e-Silva et al., 2014). The results suggest that there may be an independent mechanism and pathway for oral carbohydrate detection, but as yet, there is not method for assessing carbohydrate detection thresholds in humans. 

A total of 30 people will participate in this project and subjects must be over the age of 18 years. It is also preferred that subjects are non-smokers.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Russell Keast

Address

Centre of Advanced Sensory Science, Deakin University
221 Burwood Highway, Burwood, 3125, VIC

Country

Australia

Phone

+61 3 92446944

Fax

russell.keast@deakin.edu.au

Contact person for public queries

Name

Julia Low

Address

Centre of Advanced Sensory Science, Deakin University
221 Burwood Highway, Burwood, 3125, VIC

Country

Australia

Phone

+61 3 92517247

Fax

yqlow@deakin.edu.au

Contact person for scientific queries

Name

Russell Keast

Address

Centre of Advanced Sensory Science, Deakin University
221 Burwood Highway, Burwood, 3125, VIC

Country

Australia

Phone

+61 3 92446944

Fax

russell.keast@deakin.edu.au

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	Carbohydrate taste sensitivity is associated with starch intake and waist circumference in adults.	2017	https://dx.doi.org/10.3945/jn.117.254078
Embase	Evidence supporting oral sensitivity to complex carbohydrates independent of sweet taste sensitivity in humans.	2017	https://dx.doi.org/10.1371/journal.pone.0188784

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

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