Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000917336
Ethics application status
Not required
Date submitted
15/06/2017
Date registered
22/06/2017
Date last updated
22/06/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Intake of free sugars and micronutrient dilution in Australian adults
Scientific title
Intake of free sugars and micronutrient dilution in Australian adults
Secondary ID [1] 292209 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
micronutrient dilution 303698 0
obesity 303699 0
nutrient deficiency 303700 0
Condition category
Condition code
Public Health 303071 303071 0 0
Epidemiology
Diet and Nutrition 303081 303081 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The independent variable is the intake of free sugar, which is defined by the WHO as all monosaccharides and disaccharides added to foods by the manufacturer, cook, or consumer, plus sugars naturally present in honey, syrups, and fruit juices.

Each participant completed two 24-hr recall, on two non-consecutive days, using the Automated Multiple-Pass Method (AMPM) developed by the Agricultural Research Service of the United States Department of Agriculture (USDA)
Intervention code [1] 298365 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302450 0
The primary dependent variable is the micronutrient intake. This was translated from the dietary intake data of the survey, which was collected from two 24-hr recalls. The dietary intake data were then translated into nutrient intake using the AUSNUT2011-13 food composition database.
Timepoint [1] 302450 0
two 24-hr recall periods on non-consecutive days
Secondary outcome [1] 336055 0
Food group intake data. This was from the dietary intake data of the survey, which was collected using two 24-hr recalls.
Timepoint [1] 336055 0
two 24-hr recall periods on non-consecutive days

Eligibility
Key inclusion criteria
Usual residents of private dwellings in urban and rural areas of Australia, covering about 97% of the people living in Australia. Dietary data from those whose age was equal to or greater than 19 years old were included in this analysis.
Minimum age
19 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Implausible dietary intake, as determined by the Goldberg cut-off method

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
29/05/2011
Date of last participant enrolment
Anticipated
Actual
9/06/2012
Date of last data collection
Anticipated
Actual
9/06/2012
Sample size
Target
12366
Accrual to date
Final
12153
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 296748 0
Government body
Name [1] 296748 0
Australian Government Department of Health and Ageing
Country [1] 296748 0
Australia
Primary sponsor type
Individual
Name
Dr. Jimmy Louie
Address
5S-14, Kadoorie Biological Sciences Bldg,
The University of Hong Kong,
1 Pokfulam Road,
Pokfulam, Hong Kong
Country
Hong Kong
Secondary sponsor category [1] 295738 0
None
Name [1] 295738 0
Address [1] 295738 0
Country [1] 295738 0

Ethics approval
Ethics application status
Not required
Ethics committee name [1] 297974 0
Ethics committee address [1] 297974 0
Ethics committee country [1] 297974 0
Date submitted for ethics approval [1] 297974 0
Approval date [1] 297974 0
Ethics approval number [1] 297974 0

Summary
Brief summary
There has been an increasing concern on the possible negative effects of excessive sugar intake, particularly added sugar, on the quality of diet and health status. Added sugar was found to be associated with poorer nutrient intake. A similar impact on micronutrient dilution was expected from free sugar as an estimation of approximately 10 g difference between added sugar and free sugar intake was found in the Australian population. The hypotheses of the current analysis include: a) the WHO cut-offs were not suitable for assessing micronutrient dilution; and b) micronutrient dilution is not evident until %energy from free sugars reaches 25% or above.
Trial website
Trial related presentations / publications
Australian Bureau of Statistics, 2016, Australian Health Survey: Consumption of added sugars, 2011-12 , cat. no. 4364.0.55.011, viewed 16 June 2016. URL: http://www.abs.gov.au/ausstats/[email protected]/Lookup/4364.0.55.011main+features12011-12
Public notes
Ethics approval were not required since this is a secondary analysis.

Contacts
Principal investigator
Name 75634 0
Dr Jimmy Chun Yu Louie
Address 75634 0
5S-14, Kadoorie Biological Sciences Building, The University of Hong Kong, 1 Pokfulam Road,
Country 75634 0
Hong Kong
Phone 75634 0
+852 2299 0677
Fax 75634 0
Email 75634 0
[email protected]
Contact person for public queries
Name 75635 0
Dr Jimmy Chun Yu Louie
Address 75635 0
5S-14, Kadoorie Biological Sciences Building, The University of Hong Kong, 1 Pokfulam Road,
Country 75635 0
Hong Kong
Phone 75635 0
+852 2299 0677
Fax 75635 0
Email 75635 0
[email protected]
Contact person for scientific queries
Name 75636 0
Dr Jimmy Chun Yu Louie
Address 75636 0
5S-14, Kadoorie Biological Sciences Building, The University of Hong Kong, 1 Pokfulam Road,
Country 75636 0
Hong Kong
Phone 75636 0
+852 2299 0677
Fax 75636 0
Email 75636 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.