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| Name | Class |
|---|---|
| University of British Columbia | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test GUM | Experimental | This group will drink a test toddler growing up milk (GUM) with higher amounts of key nutrients |
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| Standard GUM | Active Comparator | This group will drink a standard toddler growing up milk (GUM) |
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| Comparator Group | Placebo Comparator | This group will drink liquid full fat cows' milk |
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| Population Group | No Intervention | This group will eat and drink their usual foods with no interventions. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test GUM | Other | Growing up milks (GUMs) are milk-based drinks with vitamins and minerals for toddlers and pre-school children. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Toddlers who exhibit one or more of the following criteria are excluded from enrollment in the study:
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| Name | Affiliation | Role |
|---|---|---|
| Yvonne Lamers, PhD | University of British Columbia | Principal Investigator |
| Tim Oberlander, MD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of British Columbia, Children and Women's Health Centre of British Columbia Branch | Vancouver | Canada |
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| ID | Term |
|---|---|
| D008892 | Milk |
| ID | Term |
|---|---|
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D003611 | Dairy Products |
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| Standard GUM | Other | Growing up milks (GUMs) are milk-based drinks with vitamins and minerals for toddlers and pre-school children. |
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| Cows' milk | Other | Homogenized store-bought full fat cow's milk. |
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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 |
| D005502 |
| Food |
| D019602 | Food and Beverages |