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

Nestlé

Status: Completed

Conditions: Healthy

Treatments: Other: Standard GUM; Other: Cows' milk; Other: Test GUM

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03038854

14.16.INF

Details and patient eligibility

About

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

Full 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.

Enrollment: 310 patients

Sex: All

Ages: 17 to 18 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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310 participants in 4 patient groups, including a placebo group

Test GUM

Experimental group

Description:

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

Treatment:

Other: Test GUM

Standard GUM

Active Comparator group

Description:

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

Treatment:

Other: Standard GUM

Comparator Group

Placebo Comparator group

Description:

This group will drink liquid full fat cows' milk

Treatment:

Other: Cows' milk

Population Group

No Intervention group

Description:

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