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Trial registered on ANZCTR


Registration number
ACTRN12616001575426
Ethics application status
Approved
Date submitted
8/11/2016
Date registered
15/11/2016
Date last updated
15/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Fortified milk consumption and cognitive function in primary school children
Scientific title
The impact of micronutrient and micronutrient + milk lipid enhanced milk-based formulations on cognitive function in primary school children
Secondary ID [1] 290442 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive Development 300798 0
Brain Health 300799 0
Condition category
Condition code
Mental Health 300623 300623 0 0
Studies of normal psychology, cognitive function and behaviour
Diet and Nutrition 300624 300624 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention Arms:

Participants will be asked to consume two 150ml serves of Milk per day for 24 weeks. Each of the following constitutes an active intervention arm:
1) Micronutrient enriched milk: fortified with Vitamin D (2.5 mcg/serve), Vitamin A (150mcg/serve), calcium (280mg/serve), zinc (3mg/serve); and iron (4mg/serve).

2) Milk Lipids + Micronutrient enriched milk: fortified with Vitamin D (2.5 mcg/serve), Vitamin A (150mcg/serve), calcium (280mg/serve), zinc (3mg/serve); iron (4mg/serve); and 150mg/serve milk phospholipids


Participants will present to the CSIRO Clinic at baseline and 24 weeks to donate a blood sample and undergo cognitive and physical activity testing. In addition, prior to presenting to the clinic at the nominated time points, caregivers of the participants will complete a variety of questionnaires.

Adherence will be monitored via a fortnightly survey completed online by the primary caregivers. Information collected in this survey includes serves per day of the intervention product in order to estimate compliance. Research team members will follow-up participants who are at risk of not meeting adequate compliance levels.
Intervention code [1] 296287 0
Treatment: Other
Comparator / control treatment
Placebo: a non-fortified milk beverage consisting of a blend of skim and full cream milk with no added micronutrients or milk lipids
Control group
Placebo

Outcomes
Primary outcome [1] 300035 0
Verbal Learning & Memory:

The Rey Auditory Verbal Learning Test is a measure of a variety of verbal memory related functions including short-term auditory memory, rate of learning and memory retention. The RVLT consists of 15 monosyllabic words that are presented to participants in a fixed sequence at the rate of one word every two seconds. After presentation, participants free-recall as many words as they can. The encoding-recall procedure is repeated five times. The maximum and total number of correctly repeated words are recorded.
Timepoint [1] 300035 0
Baseline, 24 weeks
Primary outcome [2] 300036 0
Working Memory:

The Digit Span task is a common psychometric measure used to assess WM capacity. In the forward-span version of this task, numbers are read aurally by the examiner at a rate of one-per-second. List sizes range from two numbers (e.g., 3 – 5) up to ten numbers. Participants repeat the number list in the same order as presented. Backwards digit span is identical to forward in presentation but participants are required to recall the numbers in reverse order (e.g., “3 – 5 – 8” would be recalled as “8 – 5 – 3”). This test takes approximately 10 minutes to complete. Performance is assessed for forward and backward span, as well as combined Working Memory score.
Timepoint [2] 300036 0
Baseline, 24 weeks
Primary outcome [3] 300037 0
Attention:

The Children’s Color Trails Test 1 & 2 (CCTT) is an individually administered, orthographic (paper and pencil), neuropsychological instrument designed to provide an objectively scored measure of sustained visual attention, sequencing, psychomotor speed, and cognitive flexibility. In CCTT1, the participant is required to connect a series of randomly arrange numbers in ascending order from 1 through 15. In CCTT2, the participant alternates between sequencing number and colours. Performance on both tasks is combined to reflect overall sustained attention, and an interference score is calculated as the difference between the two tasks-
Timepoint [3] 300037 0
Baseline, 24 weeks
Secondary outcome [1] 328875 0
Global Cognitive Function:

The Raven’s Coloured Progressive Matrices is a nonverbal reasoning test measuring performance IQ and general cognitive function. In this test, 36 items consisting of incomplete puzzles are presented to participants, who select the missing piece for the solution from a set of answer options presented. This test is completed under a 15-minute time limit. Scores are expressed in raw form and percentile form based on normative data.
Timepoint [1] 328875 0
Baseline, 24 weeks
Secondary outcome [2] 328989 0
Child behaviour throughout the trial will be measured using the following instruments, which are completed by the primary caregiver:

Behaviour Rating Inventory of Executive Function (BRIEF)
Strengths and Difficulties Questionnaire
Child Health and Illness Profile – Child Edition
Timepoint [2] 328989 0
Baseline (week 0), 12 and 24wks
Secondary outcome [3] 328990 0
Nutritional intake will be monitored through the use of 24-hr food recalls. Caregivers will complete two 24 hour recalls at each collection point
Timepoint [3] 328990 0
Baseline (week 0), 12 and 24wks
Secondary outcome [4] 328991 0
Physical Fitness measures include:

4 X 10m Shuttle Run (Motor Fitness)
Handgrip Strength (Musculoskeletal fitness)
Standing Long Jump (Musculoskeletal fitness)
Timepoint [4] 328991 0
Baseline, 24 weeks
Secondary outcome [5] 328992 0
Body Composition as measured via:

Bioelectrical Impedance Aanalysis
Weight
Height
Timepoint [5] 328992 0
Baseline, 24 weeks
Secondary outcome [6] 328993 0
Biochemical Assessment:

Haematological testing will be used to measure Haemoglobin, Serum 25(OH)D, Iron Studies (serum iron, ferritin, TIBC), Serum C-Reactive Protein, Serum Calcium, and Plasma Zinc.
Timepoint [6] 328993 0
Baseline, 24 weeks
Secondary outcome [7] 328994 0
Pubertal Stage as measured via:

Menstruation questions (girls 9+ years only)
Foot Length
Serum luteinizing Hormone (girls only)
Timepoint [7] 328994 0
Baseline, 24 weeks
Secondary outcome [8] 328995 0
Serum Complex Milk Lipids:

Haematological testing will be conducted to determine total CMLs levels inclusive of gangliosides, sphingomyelins, phospholipids in serum.
Timepoint [8] 328995 0
Baseline, 24 weeks
Secondary outcome [9] 329088 0
Reaction Time

Two-choice and Four-choice Reaction Time tasks will be used to assess speed of reaction and attention. Both of these tasks are completed using a computer.
Timepoint [9] 329088 0
Baseline, 24 weeks

Eligibility
Key inclusion criteria
Aged between 7 and 9-years + 4-months at baseline
<=1.5 serves per day of core whole dairy food, e.g. milk, cheese, yoghurt
Minimum age
84 Months
Maximum age
112 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Children who don’t consume Dairy for health reasons
* Children who won’t consume Dairy because of a dislike, or for religious reasons
* Children taking micronutrient supplements (e.g. Multivitamins, Calcium supplements)
* A diagnosed behavioural or other developmental disorder
* Blind
* Deaf
* Unable/unwilling to wear prescribed hearing aid &/or prescription glasses during the cognitive assessment
* Primary language other than English
* Diabetes (Type 1 or 2)
* Epilepsy
* A disorder or medical condition affecting physical movement

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)
Randomisation of participants to treatment groups will be determined by random allocation. Eligible, recruited participants will be assigned a participant number. The participant will receive the treatment that has been randomly allocated to that participant number.

Blinding will be achieved by enlisting a non-institutional staff member residing outside of the state who will code the treatments and maintain the key to this code until data collection and analysis is completed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be achieved by computerized sequence generation.
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
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/11/2016
Actual
Date of last participant enrolment
Anticipated
10/04/2017
Actual
Date of last data collection
Anticipated
19/11/2017
Actual
Sample size
Target
360
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 294886 0
Commercial sector/Industry
Name [1] 294886 0
Fonterra Co-operative Group Ltd
Country [1] 294886 0
New Zealand
Primary sponsor type
Government body
Name
CSIRO
Address
Gate 13 Kintore Ave Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 293723 0
None
Name [1] 293723 0
Address [1] 293723 0
Country [1] 293723 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296263 0
CSIRO Human Research Ethics Committee
Ethics committee address [1] 296263 0
Ethics committee country [1] 296263 0
Australia
Date submitted for ethics approval [1] 296263 0
11/08/2016
Approval date [1] 296263 0
14/10/2016
Ethics approval number [1] 296263 0
Proposal #18/2016

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

Contacts
Principal investigator
Name 70106 0
Dr Ian Zajac
Address 70106 0
CSIRO, Gate 13 Kintore Ave Adelaide SA 5000
Country 70106 0
Australia
Phone 70106 0
+61 8 8303 8875
Fax 70106 0
Email 70106 0
ian.zajac@csiro.au
Contact person for public queries
Name 70107 0
Kathryn Bastiaans
Address 70107 0
CSIRO, Gate 13 Kintore Ave Adelaide SA 5000
Country 70107 0
Australia
Phone 70107 0
+61 8 8303 8906
Fax 70107 0
Email 70107 0
kathryn.bastiaans@csiro.au
Contact person for scientific queries
Name 70108 0
Ian Zajac
Address 70108 0
CSIRO, Gate 13 Kintore Ave Adelaide SA 5000
Country 70108 0
Australia
Phone 70108 0
+61 8 8303 8875
Fax 70108 0
Email 70108 0
ian.zajac@csiro.au

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.