Growing Up Milk (GUM) Intake and Nutrient Status of Toddlers

Study Overview
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Brief Summary
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The purpose of this study is to determine the nutritional and cognitive effects of consuming Growing Up Milks (GUMs) and cow's milk.

Detailed Description
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Single-site, double blind, partially randomized, controlled, 4-arm parallel group clinical trial. The purpose of this study is to determine if consuming nutrient enriched growing up milk improves the nutrition status and cognitive performance in healthy toddlers.

Official Title
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Effects of Milk Intake on Nutrient Status and Neurocognitive Development in Toddlers: a Partially Randomized and Controlled Trial

Conditions
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Healthy

Intervention / Treatment
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* Other: Test GUM
* Other: Standard GUM
* Other: Cows' milk


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having obtained his/her parent's(s') or his/her legal guardian written informed consent and signed and dated informed consent. Age 17 - 18 months at enrolment. Singleton, full-term gestational birth (≥ 37 completed weeks of gestation), with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg Toddler's parent(s)/guardian is of legal age of consent, has sufficient command of English language to complete the informed consent and other study documents, and is willing and able to fulfill the requirements of the study protocol Toddler's parent(s)/guardian can be contacted directly by telephone or email throughout the study Exclusion Criteria: Toddlers who exhibit one or more of the following criteria are excluded from enrollment in the study: Chronic infectious, metabolic, genetic illness or other disease including any condition that impacts feeding or may impact outcome measures Known or suspected cows' milk protein intolerance / allergy or severe food allergies that impact diet Toddlers fed vegan, vegetarian, or vegetarian plus fish diets Cognitive or developmental disorders Breast milk used exclusively in place of all other milk, and/or milk alternatives at 17-18 months (GUM & cows' milk group exclusion only, eligible for population group) Consuming supplement(s) of relevance to the study outcome relating diet to status, docosahexaenoic acid (DHA), lutein, and/or choline in amounts >%10 requirements Toddlers or toddlers' family who in the Investigator's judgment cannot be expected to comply with the protocol or study procedures

Ages Eligible for Study
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Minimum Age: 17 Months
Maximum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test GUM<br>This group will drink a test toddler growing up milk (GUM) with higher amounts of key nutrients | Other: Test GUM<br>* Growing up milks (GUMs) are milk-based drinks with vitamins and minerals for toddlers and pre-school children.<br>* Other names: Growing up milk;|
| Active Comparator: Standard GUM<br>This group will drink a standard toddler growing up milk (GUM) | Other: Standard GUM<br>* Growing up milks (GUMs) are milk-based drinks with vitamins and minerals for toddlers and pre-school children.<br>* Other names: Growing up milk;|
| Placebo Comparator: Comparator Group<br>This group will drink liquid full fat cows' milk | Other: Cows' milk<br>* Homogenized store-bought full fat cow's milk.<br>|
| No Intervention: Population Group<br>This group will eat and drink their usual foods with no interventions. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of blood nutrient markers after 6 months of intervention | To compare blood status of the key nutrients of interest after 180 days of intervention in toddlers randomized in a double-blind manner to Test GUM compared to standard GUM. A non-randomized group for comparison will drink either cows' milk (comparator group) as currently recommended by Health Canada, or participate in a reference group with no drinking or feeding interventions. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Executive function and language development | To assess the effect of milk/drink on measures of neurological development. Standard and validated tools will be used in the assessment including Bayley Scales of Infant Development III | 6 months | 
| Visual acuity with Teller Acuity Cards | To characterize the effects of milk/drink on visual acuity | 6 months | 
| Behavioural development | To characterize the effects of milk/drink on behavioural development using standard questionnaires including the Child Behaviour Checklist (CBCL) | 6 months | 
| Dietary nutrient intake | To characterize effects of milk/drink on dietary intake of energy, macronutrients and key nutrients of interest using the Food Frequency Questionnaire | 6 months |