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Trial registered on ANZCTR


Trial ID
ACTRN12614000918628
Ethics application status
Approved
Date submitted
24/07/2014
Date registered
27/08/2014
Date last updated
10/04/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomised Control Trial in children aged 12-23 months consuming Growing up Milk - lite or cow's milk.
Scientific title
A multi-centre, double blind, randomised, placebo controlled trial to evaluate the effect of consuming Growing Up Milk ‘lite’ on body composition in children aged 12 – 23 months.
Secondary ID [1] 285052 0
None
Universal Trial Number (UTN)
Trial acronym
GUMLi
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Body Composition Profile 292574 0
Nutritional Status 292782 0
Cognitive Development 292783 0
Condition category
Condition code
Diet and Nutrition 292876 292876 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The children will be randomised into two groups, to receive either GUMLi or homogenised cow’s milk and will be followed for 12 months. The Growing Up Milk - "lite" is a toddler milk similar in composition to a commercially available toddler milk, but with reduced energy.

Intervention: Growing Up Milk Lite

Dose: 2 * 150ml of formula per day for a total of 12 months (from when the child turns 1 year of age until they turn 2 years of age).

The Growing Up Milk is lower in energy than cow's milk and contains added micronutrients, dietary fibre and probiotics.
Key differences in Growing Up Milk are:
- 89.3kJ per 150mL serve
- 1.1mcg Vitamin D per 150mL serve
- 2.5mg Iron per 150mL serve
- 174.3mg Calcium per 150mL serve

Compliance will be measured sing information from monthly telephone interviews on the volume of milk consumed by the children in the previous 24 hours. Both study groups consume the same amounts of milk and have measures taken at identical time points.

Intervention code [1] 289886 0
Treatment: Other
Comparator / control treatment
Control: Standard cow’s milk

Dose: 2 * 150mL of formula per day for a total of 12 months (from when the child turns 1 year of age until they turn 2 years of age).
Control group
Placebo

Outcomes
Primary outcome [1] 292749 0
Percentage body fat at 2 years of age measured with subjects lying supine using a commercially available multi-frequency bioelectrical impedance analysis device.
Timepoint [1] 292749 0
Baseline, at 6 and 12 months after intervention commencement
Secondary outcome [1] 309600 0
Full blood count, biochemical iron and vitamin D status and sensitive C-reactive protein
Timepoint [1] 309600 0
Baseline and 12 months following commencement of intervention
Secondary outcome [2] 309601 0
Cognitive Outcomes measured using the Bayley III Scales of Infant Development and the Social-Emotional and Adaptive Behaviour Questionnaire. We will also use a Temperament Scale (IBQ-R and ECBQ)
Timepoint [2] 309601 0
Baseline and 12 months following commencement of intervention
Secondary outcome [3] 309602 0
Dietary intake profile using a Food Frequency Questionnaire and administer-assisted 24 hour recalls.
Timepoint [3] 309602 0
Baseline, at 6 and 12 months following commencement of intervention
Secondary outcome [4] 309607 0
Height, weight and waist circumference
Timepoint [4] 309607 0
Baseline, at 3, 6, 9, 12 months after commencement of intervention

Eligibility
Key inclusion criteria
We will enrol children prior to the age of 12 months. They will remain in the study until they reach the age of 24 months.

Children will be eligible to enrol if they are healthy and aged less than 12 months
Minimum age
11 Months
Maximum age
12 Months
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children will be ineligible to enrol if they:

Have a developmental disability (i.e. autism, intellectual disability)

Have a significant health impairment that is likely to influence their nutritional status (e.g. Cerebral Palsy or a chronic illness known to cause malabsorption)

Taking routine medication that is likely to interfere with iron absorption

Have iron deficiency anaemia (Hb<100g/L).

Have a medically diagnosed allergy to cow’s milk; or

Parents whose written or spoken English comprehension is likely to make participation difficult for them or result in incomplete data collection for the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Enrolment:
Children will be eligible to be enrolled if they are healthy and aged less than 12 months.

Children will be recruited from urban central Auckland and Brisbane. Recruitment will occur via Community Outreach Campaigns including media releases, posters and flyers displayed in GP practices, early childhood centres and through Well Child providers e.g. Plunket (NZ)

Multiple recruitment strategies will be used, including self-referral, consent to contact via a health professional or early childhood workers etc. The product complies with Food Standards Australia and New Zealand guidelines.

Study intervention:
Participants will be randomised to one of two treatment groups; either Growing up Milk ‘Lite’ or whole pasteurised and homogenised cow’s milk.

The Growing up Milk ‘Lite’ is a toddler milk similar in composition to the commercially available Aptamil Gold+ toddler milk (Danone Pty Ltd), but with reduced energy content. The product complies with Food Standards Australia and New Zealand guidelines.

Both milks will be supplied by the researchers at no cost to the participant. Parents will be required to have their toddler consume 300ml of the supplied milk each day for a total of 12 months (that is, from when the child turns 1 year of age till when they turn 2 years of age).

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation and blinding:
Both the Growing up milk ‘lite’ and the cow’s milk will be packaged in identical 900g tins. The milks will be allocated using a random number allocation (the number of variables currently being determined). The researchers will be blinded to which milks constitute each letter allocation. Block randomisation will be completed in consultation with a statistician and allocation sequence will be concealed.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size estimates:
For a change in percentage body fat: A sample size of 64 in each arm would be able to detect 0.5 of a SD of difference in % body fat between each arm. 80 children will be enrolled in each arm of the study to allow for attrition.


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment outside Australia
Country [1] 6249 0
New Zealand
State/province [1] 6249 0
Auckland

Funding & Sponsors
Funding source category [1] 289659 0
Commercial sector/Industry
Name [1] 289659 0
Danone Australia
Address [1] 289659 0
Nutricia Australia Pty Ltd
P.O. Box 1007
North Ryde Business Centre
NSW 1670
Country [1] 289659 0
Australia
Primary sponsor type
University
Name
The University of Auckland, Faculty of Medical and Health Science
Address
85 Park Road
Grafton
Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 288350 0
University
Name [1] 288350 0
The University of Queensland
Address [1] 288350 0
Brisbane
St Lucia
QLD 4072
Country [1] 288350 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291395 0
Medical Research Ethics Committee (MREC) / Behavioural & Social Sciences Ethical Review Committee (BSSERC)
Ethics committee address [1] 291395 0
Ethics Coordinator
UQ Research & Innovation
Cumbrae-Stewart Building
Brisbane, St Lucia
THE UNIVERSITY OF QUEENSLAND QLD 4072

Ethics committee country [1] 291395 0
Australia
Date submitted for ethics approval [1] 291395 0
04/08/2014
Approval date [1] 291395 0
16/01/2015
Ethics approval number [1] 291395 0
2014001318
Ethics committee name [2] 291396 0
Health and Disabilities ethics Committee
Ethics committee address [2] 291396 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington 6145
Ethics committee country [2] 291396 0
New Zealand
Date submitted for ethics approval [2] 291396 0
04/08/2014
Approval date [2] 291396 0
03/11/2014
Ethics approval number [2] 291396 0
14/NTB/152

Summary
Brief summary
Study Aims
To determine if consuming Growing up milk ‘lite’ (GUMLi) compared to standard cow’s milk improves nutritional status, cognitive development and body composition profile (and health outcomes) in 1-2 year olds.

Specific Objectives
1. To recruit an ethnically diverse sample of children aged prior to 1 year of age;
2. Randomise children to receive GUMLi or cow’s milk and retain children in study on intervention for 12 months from 1 year of age (+/- 4 weeks);
3. Measure anthropometry, biomarkers of macro- and micro- nutrient status, cognitive functioning, and dietary intake from 1 (+/- 4 weeks) year of age to 2 (+/- 4 weeks) years of age

Study hypotheses
1. Children who consume GUMLi from age 1-2 years have a linear growth rate that is similar to children who consume cow’s milk from age 1-2 years and a % body fat increase that is less than children who consume cow’s milk from age 1-2 years.
2. Children who consume GUMLi from age 1-2 years compared to children who consume cow’s milk from age 1-2 years will be less likely to have vitamin D and iron insufficiency as defined by measurement of relevant serum biomarkers.
3. Children who consume GUMLi from age 1-2 years will have improved dietary profiles in comparison to children who consume cow’s milk from 1-2 years.
4. Children who consume GUMLi milk from age 1-2 years will have better developmental scores on the Bayley’s Scales of Infants Development in comparison to children who consume cow’s milk from 1-2 years.
Trial website
www.gumli.auckland.ac.nz
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50198 0
A/Prof Clare Wall
Address 50198 0
Academic Director- Nutrition and Dietetics
Discipline of Nutrition, School of Medical Science
Medical School Campus
University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country 50198 0
New Zealand
Phone 50198 0
+64 9 923 9875
Fax 50198 0
Email 50198 0
c.wall@auckland.ac.nz
Contact person for public queries
Name 50199 0
Mrs Tania Milne or Rebecca Hill
Address 50199 0
GUMLi Trial Project Manager
Medical School Campus
University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country 50199 0
New Zealand
Phone 50199 0
+64 9 923 9875
Fax 50199 0
Email 50199 0
gumli@auckland.ac.nz
Contact person for scientific queries
Name 50200 0
Prof Peter Davies
Address 50200 0
Queensland Children’s Medical Research Unit
The University of Queensland
Brisbane
QLD 4072
Country 50200 0
Australia
Phone 50200 0
+61 7 3365 5308
Fax 50200 0
Email 50200 0
ps.davies@uq.edu.au