Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001032347
Ethics application status
Not required
Date submitted
11/07/2017
Date registered
17/07/2017
Date last updated
17/07/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Intake of free sugars and micronutrient dilution in Australian children and adolescents
Scientific title
Intake of free sugars and micronutrient dilution in Australian children and adolescents
Secondary ID [1] 292415 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Micronutrient dilution 303999 0
Obesity 304000 0
Nutrient deficiency 304001 0
Condition category
Condition code
Diet and Nutrition 303335 303335 0 0
Other diet and nutrition disorders
Public Health 303338 303338 0 0
Epidemiology
Diet and Nutrition 303349 303349 0 0
Obesity

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 definned 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, with at least eight days apart, using the Automated Multiple-Pass Method (AMPM) developed by the Agricultural Research Service of the United States Department of Agriculture (USDA). If permission was granted by a parent or guardian, children aged 15 years or above were interviewed in person. For those without parental consent or under the age of 15, an adult living in the same household with the children responded on their behalf.
Intervention code [1] 298586 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302725 0
Intake of the following micronutrients: dietary fiber, vitamin A (as retinol equivalents), thiamin, riboflavin, dietary folate equivalent, vitamin C, vitamin E, calcium, iodine, iron, magnesium, phosphorus, potassium, zinc, linoleic acid, alpha-linolenic acid, long chain omega-3 fatty acid, saturated fat, and sodium. These intake data were translated from the dietary intake data collected from two 24-hr recalls using the AUSNUT2011-13 food composition database.
Timepoint [1] 302725 0
two 24-hr recall periods on non-consecutive days
Secondary outcome [1] 336831 0
Intake data of the following food groups: non-alcoholic beverages, cereal grains and products, cereal-based products, fats and oils, fish, seafood and products, fruit and fruit-based products, eggs and egg-based products, meat, poultry and game and their products, dairy products, dairy alternatives, soups, seeds, nuts, and their products, sauces, vegetables, legumes and legume-based products, formulated foods, herbs and spices, infant foods, non-alcoholic beverages, savory snacks, sugars, confectionery, and alcoholic beverages. These intake data were translated from the dietary intake data collected from two 24-hr recalls according to the Australian Guide to Healthy Eating 2013.
Timepoint [1] 336831 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 between 2 - 18 years old were included in this analysis.
Minimum age
2 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Non-usual residents of Australia

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] 296964 0
Government body
Name [1] 296964 0
Australian Government Department of Health and Ageing
Country [1] 296964 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] 295969 0
None
Name [1] 295969 0
Address [1] 295969 0
Country [1] 295969 0

Ethics approval
Ethics application status
Not required
Ethics committee name [1] 298169 0
Ethics committee address [1] 298169 0
Ethics committee country [1] 298169 0
Date submitted for ethics approval [1] 298169 0
Approval date [1] 298169 0
Ethics approval number [1] 298169 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 was not needed for this study as this is a secondary analysis on a pre-existing dataset.

Contacts
Principal investigator
Name 76210 0
Dr Jimmy Chun Yu Louie
Address 76210 0
5S-14, Kadoorie Biological Sciences Building, The University of Hong Kong, 1 Pokfulam Road
Country 76210 0
Hong Kong
Phone 76210 0
+852 2299 0677
Fax 76210 0
Email 76210 0
[email protected]
Contact person for public queries
Name 76211 0
Dr Jimmy Chun Yu Louie
Address 76211 0
5S-14, Kadoorie Biological Sciences Building, The University of Hong Kong, 1 Pokfulam Road
Country 76211 0
Hong Kong
Phone 76211 0
+852 2299 0677
Fax 76211 0
Email 76211 0
[email protected]
Contact person for scientific queries
Name 76212 0
Dr Jimmy Chun Yu Louie
Address 76212 0
5S-14, Kadoorie Biological Sciences Building, The University of Hong Kong, 1 Pokfulam Road
Country 76212 0
Hong Kong
Phone 76212 0
+852 2299 0677
Fax 76212 0
Email 76212 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
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