Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613000466741
Ethics application status
Approved
Date submitted
23/04/2013
Date registered
24/04/2013
Date last updated
26/09/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Identifying why some people consume excess fat. A twin study.
Scientific title
In healthy twin pairs, does a high fat diet over an eight week period, compared with a low fat diet, result in decreased sensitivity to the taste of fatty acids, lower satiety levels and increased preferences for high fat foods.
Secondary ID [1] 282390 0
Nil
Universal Trial Number (UTN)
U1111-1142-2718
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 288971 0
Condition category
Condition code
Diet and Nutrition 289309 289309 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eight week dietary intervention that is either high- or low-fat. These diets are equated for energy intake, with the high-fat diet consisting of 40% fat, 25% protein and 35% carbohydrate. The low-fat diet will consist of 20% fat, 25% protein and 55% carbohydrate. Diets will consist of different caloric intake for each individual participant based on their energy needs. Participants will have an initial consultation with a dietician (approx. 30 mins) prior to commencing the diet, and will be provided supplemental foods every two weeks throughout the intervention to assist with adherence to the diet. Further, participants will complete a one-day diet diary each week, and receive one short (5-10min) phone call each week to monitor compliance.
Intervention code [1] 287022 0
Lifestyle
Intervention code [2] 287023 0
Treatment: Other
Intervention code [3] 287028 0
Prevention
Comparator / control treatment
The high-fat diet will be compared with a low-fat diet consumed for the same period of time.
Control group
Active

Outcomes
Primary outcome [1] 289423 0
Taste sensitivity to fatty acids, as measured by determining the participant's threshold for detecting fatty acids in a milk solution. Participants will be given two control milk samples, with no fatty acid, and a third sample with increasing fatty acid concentration. Taste threshold will be determined when participants can correctly identify the milk with fatty acid identified three times in a row.
Timepoint [1] 289423 0
Assessed at baseline, week four and week eight of the dietary intervention.
Primary outcome [2] 289424 0
Preference for high fat foods. Participants will be given a series of high and low fat options (e.g. full fat compared with fat free chocolate mousse), without knowing which is which, and will have to choose which they prefer.
Timepoint [2] 289424 0
Assessed at baseline, week four and week eight of the dietary intervention.
Primary outcome [3] 289425 0
Fatty acid taste receptor expression. This will be determined by biopsy of fungiform papillae and subsequent RNA expression analysis.
Timepoint [3] 289425 0
Assessed at baseline and week eight of the dietary intervention.
Secondary outcome [1] 302446 0
PROP sensitivity. Participants will be given a sample of PROP, and will have to rate how it tastes on a general labelled magnitude scale.
Timepoint [1] 302446 0
Baseline
Secondary outcome [2] 302447 0
Papillae density. This is measured by staining the tongue with blue food dye in order to see the papillae more clearly. The tongue will be photographed, and the papillae within a certain area will be counted.
Timepoint [2] 302447 0
Baseline
Secondary outcome [3] 302448 0
Fat ranking ability. This will be tested by giving participants four custard samples with different fat concentrations, and asking them to rank them from highest to lowest fat.
Timepoint [3] 302448 0
Baseline, week four and week eight of the dietary intervention.
Secondary outcome [4] 302449 0
Lingual lipase, as determined by saliva samples.
Timepoint [4] 302449 0
Baseline, week four and week eight of the dietary intervention.

Eligibility
Key inclusion criteria
Must be a twin (monozygotic or dizygotic). Must be able to speak English (as information and consent forms will not be translated).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals under 18. Individuals who do not speak English. Individuals who are not twins.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled 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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/06/2013
Actual
15/05/2014
Date of last participant enrolment
Anticipated
Actual
2/03/2016
Date of last data collection
Anticipated
Actual
4/07/2016
Sample size
Target
100
Accrual to date
Final
92
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 287167 0
Government body
Name [1] 287167 0
National Health and Medical Research Council
Country [1] 287167 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Hwy,
Burwood, 3125
Vic
Country
Australia
Secondary sponsor category [1] 285933 0
Government body
Name [1] 285933 0
CSIRO
Address [1] 285933 0
CSIRO Enquiries
Locked Bag 10
Clayton South VIC 3169
Australia
Country [1] 285933 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289163 0
Deakin Human Research Ethics Committee
Ethics committee address [1] 289163 0
221 Burwood Hwy,
Burwood, 3125
Vic
Ethics committee country [1] 289163 0
Australia
Date submitted for ethics approval [1] 289163 0
24/04/2013
Approval date [1] 289163 0
10/04/2014
Ethics approval number [1] 289163 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 than others; one factor may be variance in the taste system due to genetic and environmental factors such as diet. The present study aims to identify and investigate the mechanisms linking individual differences in taste with obesity. The mechanisms thought to be in play relate to our sense of taste, including taste receptors and their responsiveness to fatty acids, satiety levels resulting from consuming high fat foods, and food preferences. It is predicted that for susceptible individuals, consuming a high fat diet will negatively influence their responsiveness to fatty acids, increase their preference for high fat foods and decrease their hormonal and perceived satiety levels following food consumption. Each of these mechanisms has the potential to lead to an increase in dietary fat consumption, and BMI. Previous research has indicated that within pairs of BMI discordant monozygotic twins, the twin with the higher BMI has significantly lower taste responses to fatty acids, indicating that their diet may be related to their fatty acid taste sensitivity.
This study aims to include 100 twin pairs (half monozygotic and half dizygotic) recruited from the Australian Twin Registry. These participants will be over 18 years of age. Twin pairs will be randomized into one of two weight maintenance diets (high- or low-fat). Participants will consume this allocated diet for eight weeks, with weekly diet diaries being assessed for compliance, in addition to weekly satiety questionnaires. Prior to baseline testing, participants will complete a four-day diet diary, the Cancer Council of Victoria food frequency questionnaire, the restrained eaters questionnaire, and a like-dislike questionnaire. Further testing will occur at baseline, week four and week eight. Each testing session will include a 24-hour dietary recall, taste function assessment, a fat-ranking task using custards, saliva samples, papillae density testing, preference testing for seven regular and low fat foods, anthropometry and a fungiform papillae biopsy. During baseline testing, participants will also be tested for PROP sensitivity, which is a heritable trait. Results will be compared at each time point to determine the effect of a high- or low-fat diet on fatty acid taste responses and satiety.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39526 0
Prof Russell Keast
Address 39526 0
School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Hwy,
Burwood, 3125
Vic
Country 39526 0
Australia
Phone 39526 0
+61 3 924 46944
Fax 39526 0
Email 39526 0
[email protected]
Contact person for public queries
Name 39527 0
Prof Russell Keast
Address 39527 0
School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Hwy,
Burwood, 3125
Vic
Country 39527 0
Australia
Phone 39527 0
+61 3 924 46944
Fax 39527 0
Email 39527 0
[email protected]
Contact person for scientific queries
Name 39528 0
Prof Russell Keast
Address 39528 0
School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Hwy,
Burwood, 3125
Vic
Country 39528 0
Australia
Phone 39528 0
+61 3 924 46944
Fax 39528 0
Email 39528 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
EmbaseEffect of dietary fat intake and genetics on fat taste sensitivity: A co-Twin randomized controlled trial.2018https://dx.doi.org/10.1093/ajcn/nqy022
EmbaseA low-fat diet up-regulates expression of fatty acid taste receptor gene FFAR4 in fungiform papillae in humans: a co-twin randomised controlled trial.2019https://dx.doi.org/10.1017/S0007114519002368
N.B. These documents automatically identified may not have been verified by the study sponsor.