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

NCT03038854 | Completed

• 1 other identifier: 14.16.INF
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Executive function and language development

  6 months

• Visual acuity with Teller Acuity Cards

  6 months

• Behavioural development

  6 months

• Dietary nutrient intake

  6 months

Study Arms (4)

Test GUM

EXPERIMENTAL

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

Other: Test GUM

Standard GUM

ACTIVE COMPARATOR

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

Other: Standard GUM

Comparator Group

PLACEBO COMPARATOR

This group will drink liquid full fat cows' milk

Other: Cows' milk

Population Group

NO INTERVENTION

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

Interventions

Test GUM OTHER

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

Also known as: Growing up milk

Test GUM

Standard GUM OTHER

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

Also known as: Growing up milk

Standard GUM

Cows' milk OTHER

Homogenized store-bought full fat cow's milk.

Comparator Group

Eligibility Criteria

• Age: 17 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead
• University of British Columbia: collaborator

Study Sites (1)

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

Vancouver, Canada

Location

MeSH Terms

Interventions

Milk

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Officials

• Yvonne Lamers, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Tim Oberlander, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2017
• First Posted: February 1, 2017
• Study Start: February 8, 2017
• Primary Completion: July 11, 2022
• Study Completion: October 31, 2022
• Last Updated: November 28, 2022

Record last verified: 2022-11

Locations

CA (1)