Clinical trial NCT03038854: Growing Up Milk (GUM) Intake and Nutrient Status of Toddlers
Official title: Effects of Milk Intake on Nutrient Status and Neurocognitive Development in Toddlers: a Partially Randomized and Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
Collaborators: name: University of British Columbia
First posted: 2017-02-01
Enrollment: 310
Sex: ALL
Minimum age (years): 17
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Having obtained his/her parent's(s') or his/her legal guardian written informed consent and signed and dated informed consent.
2. Age 17 - 18 months at enrolment.
3. Singleton, full-term gestational birth (≥ 37 completed weeks of gestation), with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg
4. 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
5. 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:

1. Chronic infectious, metabolic, genetic illness or other disease including any condition that impacts feeding or may impact outcome measures
2. Known or suspected cows' milk protein intolerance / allergy or severe food allergies that impact diet
3. Toddlers fed vegan, vegetarian, or vegetarian plus fish diets
4. Cognitive or developmental disorders
5. 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)
6. Consuming supplement(s) of relevance to the study outcome relating diet to status, docosahexaenoic acid (DHA), lutein, and/or choline in amounts \>%10 requirements
7. Toddlers or toddlers' family who in the Investigator's judgment cannot be expected to comply with the protocol or study procedures

Primary outcomes:
measure: Comparison of blood nutrient markers after 6 months of intervention
timeFrame: 6 months
Secondary outcomes:
measure: Executive function and language development
timeFrame: 6 months
measure: Visual acuity with Teller Acuity Cards
timeFrame: 6 months
measure: Behavioural development
timeFrame: 6 months
measure: Dietary nutrient intake
timeFrame: 6 months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia, Children and Women's Health Centre of British Columbia Branch
Study officials:
affiliation: University of British Columbia
name: Yvonne Lamers, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Tim Oberlander, MD
role: PRINCIPAL_INVESTIGATOR
References: