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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Test GUM; Other: Standard GUM; Other: Cows' 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.

• Study Type: Interventional
• Enrollment (Actual): 310
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Vancouver, Canada
    • University of British Columbia, Children and Women's Health Centre of British Columbia Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nestlé
• Collaborators: University of British Columbia
• Investigators: Principal Investigator: Yvonne Lamers, PhD, University of British Columbia; Principal Investigator: Tim Oberlander, MD, University of British Columbia

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2017
• Primary Completion (Actual): July 11, 2022
• Study Completion (Actual): October 31, 2022

Study Registration Dates

• First Submitted: January 25, 2017
• First Submitted That Met QC Criteria: January 30, 2017
• First Posted (Estimate): February 1, 2017

Study Record Updates

• Last Update Posted (Actual): November 28, 2022
• Last Update Submitted That Met QC Criteria: November 24, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 14.16.INF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No