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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03038854
• Other study ID #: 14.16.INF
• Status: Completed
• Phase: N/A
• Start date: February 8, 2017
• Est. completion date: October 31, 2022

Study information

• Verified date: November 2022
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 310
• Est. completion date: October 31, 2022
• Est. primary completion date: July 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Months to 18 Months

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Test GUM
Growing up milks (GUMs) are milk-based drinks with vitamins and minerals for toddlers and pre-school children.
• Standard GUM
Growing up milks (GUMs) are milk-based drinks with vitamins and minerals for toddlers and pre-school children.
• Cows' milk
Homogenized store-bought full fat cow's milk.

Locations

Country	Name	City	State
Canada	University of British Columbia, Children and Women's Health Centre of British Columbia Branch	Vancouver

Sponsors (2)

Lead Sponsor	Collaborator
Nestlé	University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Visual acuity with Teller Acuity Cards	To characterize the effects of milk/drink on visual acuity	6 months
Secondary	Behavioural development	To characterize the effects of milk/drink on behavioural development using standard questionnaires including the Child Behaviour Checklist (CBCL)	6 months
Secondary	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