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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.
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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.
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Secondary ID [1]
282477
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None
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Universal Trial Number (UTN)
U1111-1142-8604
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Obesity
289102
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Condition category
Condition code
Diet and Nutrition
289441
289441
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0
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Obesity
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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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.
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Intervention code [1]
287135
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Not applicable
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Comparator / control treatment
There is no specific control group, however, the data collected in the study will be compared between lean and obese individuals.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
289556
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Taste sensitivity measures for sweet and fat taste using taste detection thresholds, supra-treshold intensity ratings and preference testing.
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Assessment method [1]
289556
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Timepoint [1]
289556
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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.
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Secondary outcome [1]
302730
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Dietary intake of participants through the use of a 4-day weighed food diary to assess macro- and micro-nutrient intake.
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Assessment method [1]
302730
0
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Timepoint [1]
302730
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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).
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Secondary outcome [2]
302734
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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).
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Assessment method [2]
302734
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Timepoint [2]
302734
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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.
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Secondary outcome [3]
302737
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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
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Assessment method [3]
302737
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Timepoint [3]
302737
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Anthropometric data will be collected during the first testing session.
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Secondary outcome [4]
302738
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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.
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Assessment method [4]
302738
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Timepoint [4]
302738
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Fungiform papillae count will be collected during the first testing session.
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Secondary outcome [5]
303029
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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.
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Assessment method [5]
303029
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Timepoint [5]
303029
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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.
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Secondary outcome [6]
303153
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Analysis of satiety markers and inflammatory markers.
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Assessment method [6]
303153
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Timepoint [6]
303153
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Satiety and inflammatory markers will be assessed from blood collected during the visit 1 after an overnight fast.
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Eligibility
Key inclusion criteria
Females 18-55 years
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Females
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Can healthy volunteers participate?
Yes
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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.
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Study design
Purpose
Natural history
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Duration
Cross-sectional
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Selection
Case control
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
7/06/2013
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Actual
7/06/2013
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Date of last participant enrolment
Anticipated
6/12/2013
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Actual
14/07/2014
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Date of last data collection
Anticipated
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Actual
14/08/2014
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Sample size
Target
40
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Accrual to date
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Final
39
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
287263
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Government body
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Name [1]
287263
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Commonwealth Scientific and Industrial Research Organisation (CSIRO)
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Address [1]
287263
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CSIRO Animal, Food and Health Sciences
Riverside Corporate Park
11 Julius Avenue
North Ryde
2113 NSW
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Country [1]
287263
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Australia
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Primary sponsor type
Individual
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Name
Dr Nicholas Archer
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Address
CSIRO Animal, Food and Health Sciences
Riverside Corporate Park
11 Julius Avenue
North Ryde
2113 NSW
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Country
Australia
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Secondary sponsor category [1]
286016
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None
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Name [1]
286016
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Address [1]
286016
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Country [1]
286016
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
289241
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CSIRO CSIRO Animal, Food and Health Sciences (CAFHS) Human Research Ethics Committee
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Ethics committee address [1]
289241
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Kintore Street
Adelaide 5000
South Australia
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Ethics committee country [1]
289241
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Australia
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Date submitted for ethics approval [1]
289241
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Approval date [1]
289241
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13/05/2013
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Ethics approval number [1]
289241
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HREC 13/06
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Summary
Brief summary
Each year CSIRO Animal, Food and Health Sciences perform a number of research projects involving human participants. The present study will be investigating genetic differences in sweet and fat taste and the association with dietary intake and health status.
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Trial website
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Trial related presentations / publications
Archer, N.S., Shaw, J., Cochet, M., Bunch, R., Poelman, A., Barendse, W., Duesing, K. (2017). Obesity is associated with altered gene expression in human tastebuds.XXXIX, in Annual Meeting of the Association for Chemoreception Sciences Hyatt Regency Coconut Point, Bonita Springs, Florida. (2018). Chemical Senses, 43, e71
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Public notes
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Contacts
Principal investigator
Name
39918
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Dr Nicholas Archer
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Address
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CSIRO Animal, Food and Health Sciences (CAFHS)
Riverside Corporate Park
11 Julius Avenue
North Ryde, NSW 2113
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Country
39918
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Australia
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Phone
39918
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+61 2 9490 8363
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Fax
39918
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Email
39918
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[email protected]
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Contact person for public queries
Name
39919
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Dr Nicholas Archer
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Address
39919
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CSIRO Animal, Food and Health Sciences (CAFHS)
Riverside Corporate Park
11 Julius Avenue
North Ryde, NSW 2113
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Country
39919
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Australia
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Phone
39919
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+61 2 9490 8363
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Fax
39919
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Email
39919
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[email protected]
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Contact person for scientific queries
Name
39920
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Dr Nicholas Archer
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Address
39920
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CSIRO Animal, Food and Health Sciences (CAFHS)
Riverside Corporate Park
11 Julius Avenue
North Ryde, NSW 2113
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Country
39920
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Australia
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Phone
39920
0
+61 2 9490 8363
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Fax
39920
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Email
39920
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[email protected]
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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
Obesity is associated with altered gene expression in human tastebuds.
2019
https://dx.doi.org/10.1038/s41366-018-0303-y
N.B. These documents automatically identified may not have been verified by the study sponsor.
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