Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000048583
Ethics application status
Approved
Date submitted
19/12/2014
Date registered
22/01/2015
Date last updated
22/01/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The role of fat and salt on overconsumption of food
Scientific title
The role of fat and salt concentrations on overconsumption of food in healthy participants
Secondary ID [1] 285882 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 293802 0
hypertension 293880 0
Condition category
Condition code
Diet and Nutrition 294106 294106 0 0
Obesity
Cardiovascular 294107 294107 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
-On four different days, ad libitum intake of a soup low or high in salt and low or high in fat (45 min), after a fixed breakfast (45 min).
-Arm 1: low salt and low fat. Arm 2: low salt and high fat. Arm 3: high salt and low fat. Arm 4: high salt and high fat.
-Low salt is 0.04% salt, High salt is 1% salt. Low fat is 0% fat, High fat is 10% fat. Canola oil is used for fat.
-wash out period is one week
Intervention code [1] 290863 0
Behaviour
Comparator / control treatment
cross-over intervention. All participants will consume all fat/salt combinations. The low salt and low fat will be the control.
Control group
Active

Outcomes
Primary outcome [1] 293901 0
food intake (g and kJ) of soup. The soup will be weighed before and after consumption to calculate the quantity of soup consumed.
Timepoint [1] 293901 0
Directly after food intake (15 min) at each of the 4 testing sessions
Secondary outcome [1] 312121 0
Taste sensitivity to fatty acids
Timepoint [1] 312121 0
Assessed by an ascending forced choice test, duration depends on sensitivity (between 5 and 25 minutes). This outcome is assessed before (baseline) and after the four sessions.

Eligibility
Key inclusion criteria
Healthy adult participants. Everyone who shows interest in participating the study, judge themselves as healthy and do not meet the exclusion criteria.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
smoking
difficulties with eating or swallowing
gained or lost 5 kg or more in the last year
Being pregnant of giving breastfeeding

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
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2014
Actual
1/12/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 290466 0
University
Name [1] 290466 0
Deakin University
Country [1] 290466 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood highway,
Burwood, vic 3125
Country
Australia
Secondary sponsor category [1] 289167 0
None
Name [1] 289167 0
Address [1] 289167 0
Country [1] 289167 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 53678 0
Dr Dieuwerke Bolhuis
Address 53678 0
Deakin University 221 Burwood Highway, Burwood, Vic 3125
Country 53678 0
Australia
Phone 53678 0
+ 61 392468215
Fax 53678 0
Email 53678 0
[email protected]
Contact person for public queries
Name 53679 0
Dieuwerke Bolhuis
Address 53679 0
Deakin University 221 Burwood Highway, Burwood, Vic 3125
Country 53679 0
Australia
Phone 53679 0
+61 392468215
Fax 53679 0
Email 53679 0
[email protected]
Contact person for scientific queries
Name 53680 0
Dieuwerke Bolhuis
Address 53680 0
Deakin University 221 Burwood Highway, Burwood, Vic 3125
Country 53680 0
Australia
Phone 53680 0
+61 392468215
Fax 53680 0
Email 53680 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
EmbaseSalt promotes passive overconsumption of dietary fat in humans.2016https://dx.doi.org/10.3945/jn.115.226365
N.B. These documents automatically identified may not have been verified by the study sponsor.