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

Société des Produits Nestlé (SPN)1 site in 1 country310 target enrollmentFebruary 8, 2017

ConditionsHealthy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Healthy
Sponsor: Société des Produits Nestlé (SPN)
Enrollment: 310
Locations: 1
Primary Endpoint: Comparison of blood nutrient markers after 6 months of intervention
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 8, 2017

End Date

October 31, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Société des Produits Nestlé (SPN)

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Comparison of blood nutrient markers after 6 months of intervention

Time Frame: 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.