Fortified milk consumption and cognitive function in primary school children

The impact of micronutrient and micronutrient + milk lipid enhanced milk-based formulations on cognitive function in primary school children

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616001575426

Enrollment

360

Registered

2016-11-15

Start date

2016-11-21

Completion date

2017-04-10

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of this research is to test the impact of micronutrient enhance or micronutrient + milk lipid enhanced milk beverages on cognitive function in primary school aged children. The intervention products have been formulated on the basis of growing research suggesting a beneficial role of milk lipids for supporting brain health and, by extension, cognitive function. As part of this study, children aged between 7 and 9-years + 4-months at trial commencement will be randomly allocated to an active intervention arm (micronutrient enhanced OR micronutrient + milk lipid enhanced) or placebo arm (standard milk). Participants will consume two 150ml serves of the study product daily for 24 weeks. On the basis of previous research results on both micronutrient and milk lipids, the following hypotheses are made: 1) Consumption of two serves of micronutrient + milk lipid enhance beverages daily for six months will lead to improved cognitive function compared to micronutrient and control groups. 2) Consumption of two serves of micronutrient enhanced beverages daily for six months will lead to improved cognitive function compared to the control group.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

84 Months to 112 Months

Healthy volunteers

Yes

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

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

Outcome results