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Trial registered on ANZCTR


Registration number
ACTRN12613000639729
Ethics application status
Approved
Date submitted
28/05/2013
Date registered
6/06/2013
Date last updated
4/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Genomics of sweet and fat taste in the prevention of obesity.
Scientific title
Observational study of healthy lean and obese individuals to
evaluate genetic factors, including allelic variation and taste receptor gene expression, associated with sweet and fat taste sensitivity.
Secondary ID [1] 282477 0
None
Universal Trial Number (UTN)
U1111-1142-8604
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 289102 0
Condition category
Condition code
Diet and Nutrition 289441 289441 0 0
Obesity

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational study which will evaluate participants dietary intake, weight status and taste sensitivity (taste detection threshold, supra-intensity rating and preference testing). This data will be compared with allelic variation and expression of genes involved in taste from tissue collected from blood and the oral cavity. Participants will be required for a minimum of 4 testing session, which will take place over a one month period, and each testing session will be seperated by at least 24 hours. Visit 1 will provide participants with information about the study, body measurments will be completed (weight, height, waist circumference and papillae density) and blood will be drawn (participants will attend after an overnight fast) - total time for visit 1 will be 1.5 hours. Visit 2 and 3 will collect the same data with each visit being 2.5 hours each. Participants will first provide oral samples though a non-invasive scraping technique, followed by tasting of sensory samples to determine individual sweet and fat taste measures (taste detection threshold, supra intensity ratings and preference testing). Particiapants will attend visits 2 and 3 after a 2 hour fast. During visit 4, 4-6 tastebuds will be collected from the anterior of the tongue by a medical practitioner after a 2 hour fast - total time of visit 1 hour. Additionally, a subset of particpants (n=10 - half lean half obese) will be required for a single visit (4 hours) to assess breath volatiles after the consumption of an lipid emulsion beverage. Participants will be tested after a overnight fast, and breath volatiles measured every 30-45min.
Intervention code [1] 287135 0
Not applicable
Comparator / control treatment
There is no specific control group, however, the data collected in the study will be compared between lean and obese individuals.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289556 0
Taste sensitivity measures for sweet and fat taste using taste detection thresholds, supra-treshold intensity ratings and preference testing.
Timepoint [1] 289556 0
All testing procedures will be measured in duplicate, once during both visit 2 and 3, which will be seperated by at least 24 hours. Taste measures will be compared with all secondary outcomes.
Secondary outcome [1] 302730 0
Dietary intake of participants through the use of a 4-day weighed food diary to assess macro- and micro-nutrient intake.
Timepoint [1] 302730 0
4-day weighed food diary will be completed during the study (but not on days of testing sessions). Information about the weighed food diary will be given during the first visit, along with the food diary and weigh scales. Participants will record all food and drink consumed on any 3 week days and 1 weekend day over the course of the 4 week testing procedure (therefore, total of 4 days of food intake will be measured).
Secondary outcome [2] 302734 0
Analysis of genetic variants and gene expression of genes associated with both sweet and fat taste from samples collected from blood (genetic variants and gene expression) and oral tissue (gene expression).
Timepoint [2] 302734 0
Blood and oral taste tissue will be collected first during both visits 2 and 3 after fasting for at least 2 hours and prior to taste sensitivity measures.
Secondary outcome [3] 302737 0
Anthropometric data (weight, height and waist circumference) will be collected from participants. Weight will be measured using dedicated scales (in Kg), height will be measured using a stadiometer (cm) and waist circumference using a measuring tape (cm). BMI will be calculated based on the weight and height of each participant (BMI=weight(Kg)/height(cm)^2
Timepoint [3] 302737 0
Anthropometric data will be collected during the first testing session.
Secondary outcome [4] 302738 0
Fungiform papillae count will be completed by counting the number of taste papillae within a 6mm area on the anterior tongue. The fungiform papillea count is a measure of the amount of a participants taste tissue.
Timepoint [4] 302738 0
Fungiform papillae count will be collected during the first testing session.
Secondary outcome [5] 303029 0
Analysis of breath volatiles after consumption of lipid beverage emulsion. Participants (half lean and half obese) will consume a lipid beverage after an overnight fast and breath volatiles will be measured at base line and over four hours.
Timepoint [5] 303029 0
Testing will be seperated by at least 24 hours and will be completed between visits 1 and 2. Particpants (n=10) will consume the lipid beverage after an overnight fast and breath volitiles will be measured every 30-45mins for 4 hours.
Secondary outcome [6] 303153 0
Analysis of satiety markers and inflammatory markers.
Timepoint [6] 303153 0
Satiety and inflammatory markers will be assessed from blood collected during the visit 1 after an overnight fast.

Eligibility
Key inclusion criteria
Females 18-55 years
Minimum age
18 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria:
- Restrained eaters (defined by a score greater than 12 in factor 1 of the 3 factor eating questionnaire).
- Individuals who are currently on or have been on a diet within the past 3 months.
- Individuals who ave experienced weight fluctations of greater than 3kg in the past 3 months.
- Individuals who currently smoke.
- Individuals who have had head truma or surgery and oral cancers.
- Individuals with fissured tongues or tongue lesions (including tongue piercings).
- Individuals who are on medications that may impair taste.
- Individuals with chronic diseases or infections.
- Individuals who are allergic to, or do not wish to consume dairy products or peanuts.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/06/2013
Actual
7/06/2013
Date of last participant enrolment
Anticipated
6/12/2013
Actual
14/07/2014
Date of last data collection
Anticipated
Actual
14/08/2014
Sample size
Target
40
Accrual to date
Final
39
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 287263 0
Government body
Name [1] 287263 0
Commonwealth Scientific and Industrial Research Organisation (CSIRO)
Country [1] 287263 0
Australia
Primary sponsor type
Individual
Name
Dr Nicholas Archer
Address
CSIRO Animal, Food and Health Sciences
Riverside Corporate Park
11 Julius Avenue
North Ryde
2113 NSW
Country
Australia
Secondary sponsor category [1] 286016 0
None
Name [1] 286016 0
Address [1] 286016 0
Country [1] 286016 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289241 0
CSIRO CSIRO Animal, Food and Health Sciences (CAFHS) Human Research Ethics Committee
Ethics committee address [1] 289241 0
Ethics committee country [1] 289241 0
Australia
Date submitted for ethics approval [1] 289241 0
Approval date [1] 289241 0
13/05/2013
Ethics approval number [1] 289241 0
HREC 13/06

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

Contacts
Principal investigator
Name 39918 0
Dr Nicholas Archer
Address 39918 0
CSIRO Animal, Food and Health Sciences (CAFHS)
Riverside Corporate Park
11 Julius Avenue
North Ryde, NSW 2113
Country 39918 0
Australia
Phone 39918 0
+61 2 9490 8363
Fax 39918 0
Email 39918 0
[email protected]
Contact person for public queries
Name 39919 0
Nicholas Archer
Address 39919 0
CSIRO Animal, Food and Health Sciences (CAFHS)
Riverside Corporate Park
11 Julius Avenue
North Ryde, NSW 2113
Country 39919 0
Australia
Phone 39919 0
+61 2 9490 8363
Fax 39919 0
Email 39919 0
[email protected]
Contact person for scientific queries
Name 39920 0
Nicholas Archer
Address 39920 0
CSIRO Animal, Food and Health Sciences (CAFHS)
Riverside Corporate Park
11 Julius Avenue
North Ryde, NSW 2113
Country 39920 0
Australia
Phone 39920 0
+61 2 9490 8363
Fax 39920 0
Email 39920 0
[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
SourceTitleYear of PublicationDOI
EmbaseObesity is associated with altered gene expression in human tastebuds.2019https://dx.doi.org/10.1038/s41366-018-0303-y
N.B. These documents automatically identified may not have been verified by the study sponsor.