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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Cows' milk; Other: Test GUM; Other: Standard GUM

• Registration Number: NCT03038854
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Study Timeline

• Study First Submitted: 2017-01-25
• Study First Submitted QC: 2017-01-30
• Study First Posted: 2017-02-01
• Study Start: 2017-02-08
• Primary Completion: 2022-07-11
• Study Completion: 2022-10-31
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-24
• Last Update Posted: 2022-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 310

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comparator Group	Cows' milk	This group will drink liquid full fat cows' milk
Test GUM	Test GUM	This group will drink a test toddler growing up milk (GUM) with higher amounts of key nutrients
Standard GUM	Standard GUM	This group will drink a standard toddler growing up milk (GUM)

Primary Outcome Measures

Name	Time	Method
Comparison of blood nutrient markers after 6 months of intervention	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.

Secondary Outcome Measures

Name	Time	Method
Dietary nutrient intake	6 months	To characterize effects of milk/drink on dietary intake of energy, macronutrients and key nutrients of interest using the Food Frequency Questionnaire
Behavioural development	6 months	To characterize the effects of milk/drink on behavioural development using standard questionnaires including the Child Behaviour Checklist (CBCL)
Visual acuity with Teller Acuity Cards	6 months	To characterize the effects of milk/drink on visual acuity
Executive function and language development	6 months	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

Trial Locations

Locations (1)

University of British Columbia, Children and Women's Health Centre of British Columbia Branch; 🇨🇦 Vancouver, Canada