Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001054000
Ethics application status
Approved
Date submitted
29/11/2010
Date registered
1/12/2010
Date last updated
8/02/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Heritability of fat taste sensitivity and its association with obesity
Scientific title
Heritability of fat taste sensitivity in twin pairs and its association with obesity
Secondary ID [1] 253202 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 258736 0
Condition category
Condition code
Diet and Nutrition 258894 258894 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
6-week dietary intervention using a diet containing 25% energy from fat. Core foods for the diet will be delivered to the subjects. Such foods include: low fat milk and yoghurts (including frozen yoghurt), oils, low fat bran muffins and lean meats. These foods will be incorporated into the daily diet of the subjects and so they will consume these foods when they would normally have their meals and snacks. These foods will replace the higher fat alternatives in the subjects' diets.
Intervention code [1] 257681 0
Early detection / Screening
Intervention code [2] 257688 0
Other interventions
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259744 0
Fat taste sensitivity as assessed by sensory measures. Subjects will be asked to complete a fat (and also salt, sour, bitter, sweet and umami) threshold assessment, hedonic ratings for selected foods and tongue photograph.
Timepoint [1] 259744 0
Baseline and 6-weeks after dietary intervention commencement
Secondary outcome [1] 266492 0
Dietary quality as assessed by 4-day diet diary.
Timepoint [1] 266492 0
Baseline and 6-weeks after dietary intervention commencement

Eligibility
Key inclusion criteria
Male and female mono- and di-zygotic twin pairs, aged between 18-39years, English speaking and BMI between 18-35.
Minimum age
18 Years
Maximum age
39 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals aged under 18 years or above 39 years, BMI under 18 or over 35, non-English speaking.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258153 0
Self funded/Unfunded
Name [1] 258153 0
Country [1] 258153 0
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Highway, Burwood, Victoria, 3125
Country
Australia
Secondary sponsor category [1] 257317 0
None
Name [1] 257317 0
Address [1] 257317 0
Country [1] 257317 0
Other collaborator category [1] 251707 0
Charities/Societies/Foundations
Name [1] 251707 0
Australian Twin Registry
Address [1] 251707 0
Centre for MEGA Epidemiology
School Population Health
Lvl 1, 723 Swanston St
The University of Melbourne
Victoria, Australia 3010
Country [1] 251707 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260129 0
Deakin University Human Ethics Office
Ethics committee address [1] 260129 0
Human Ethics Office, Research Services Division, Deakin University, 221 Burwood Highway, Burwood, Victoria, 3125.
Ethics committee country [1] 260129 0
Australia
Date submitted for ethics approval [1] 260129 0
Approval date [1] 260129 0
Ethics approval number [1] 260129 0
EC HEAG-H153 2009

Summary
Brief summary
A recent discovery in our laboratory demonstrated that in comparison with lean subjects, the alimentary canal (oral and gastrointestinal tract) response to fats and fatty acids in foods was attenuated in overweight and obese human subjects. This data supports evidence that overweight and obese individuals consume excess dietary fat. There are two possibilities for these findings, first, that consumption of a high-fat diet induces environmental adaptive changes in the body’s sensitivity to fat, or, second, that genetic predisposition determines an individual’s fat sensitivity. Using both monozygous and dizygous twin pairs; we will estimate the magnitude of fat sensitivity heritability and its links to obesity.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31966 0
Address 31966 0
Country 31966 0
Phone 31966 0
Fax 31966 0
Email 31966 0
Contact person for public queries
Name 15213 0
Dr Russell Keast
Address 15213 0
School of Exercise and Nutrition Sciences, Deakin University, 221 Burwood Highway, Burwood, Victoria, 3125
Country 15213 0
Australia
Phone 15213 0
+61 3 9244 6944
Fax 15213 0
Email 15213 0
[email protected]
Contact person for scientific queries
Name 6141 0
Dr Russell Keast
Address 6141 0
School of Exercise and Nutrition Sciences, Deakin University, 221 Burwood Highway, Burwood, Victoria, 3125
Country 6141 0
Australia
Phone 6141 0
+61 3 9244 6944
Fax 6141 0
Email 6141 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
No additional documents have been identified.