Effects of Milk Intake on Nutrient Status and Neurocognitive Development in Toddlers: a Partially Randomized and Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 310
- 试验地点
- 1
- 主要终点
- Comparison of blood nutrient markers after 6 months of intervention
研究概览
简要总结
The purpose of this study is to determine the nutritional and cognitive effects of consuming Growing Up Milks (GUMs) and cow's milk.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 17 Months 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Comparison of blood nutrient markers after 6 months of intervention
时间窗: 6 months
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.
次要结局
- Dietary nutrient intake(6 months)
- Behavioural development(6 months)
- Visual acuity with Teller Acuity Cards(6 months)
- Executive function and language development(6 months)