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

NCT ID: NCT03038854

Last Updated: 2022-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 310 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-08
• Study Completion Date: 2022-10-31

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Test GUM

This group will drink a test toddler growing up milk (GUM) with higher amounts of key nutrients

Group Type: EXPERIMENTAL

Test GUM

Intervention Type: OTHER

Growing up milks (GUMs) are milk-based drinks with vitamins and minerals for toddlers and pre-school children.

Standard GUM

This group will drink a standard toddler growing up milk (GUM)

Group Type: ACTIVE_COMPARATOR

Standard GUM

Intervention Type: OTHER

Growing up milks (GUMs) are milk-based drinks with vitamins and minerals for toddlers and pre-school children.

Comparator Group

This group will drink liquid full fat cows' milk

Group Type: PLACEBO_COMPARATOR

Cows' milk

Intervention Type: OTHER

Homogenized store-bought full fat cow's milk.

Population Group

This group will eat and drink their usual foods with no interventions.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Test GUM

Growing up milks (GUMs) are milk-based drinks with vitamins and minerals for toddlers and pre-school children.

Intervention Type: OTHER

Standard GUM

Growing up milks (GUMs) are milk-based drinks with vitamins and minerals for toddlers and pre-school children.

Intervention Type: OTHER

Cows' milk

Homogenized store-bought full fat cow's milk.

Intervention Type: OTHER

Other Intervention Names

Growing up milk; Growing up milk

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

• Minimum Eligible Age: 17 Months
• Maximum Eligible Age: 18 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of British Columbia

OTHER

Sponsor Role: collaborator

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yvonne Lamers, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Tim Oberlander, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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

Vancouver, , Canada

Countries

Canada

Other Identifiers

14.16.INF

Identifier Type: -

Identifier Source: org_study_id