Growing Up Formula Versus Nutritional Supplements: Effect on Catch up Growth, Micronutrient Status, and Solid Foods Intake in Toddlers With Mild or Moderate Malnutrition (KEEP Growing)

This is a pilot study to test how a growing-up formula (GUF) compares to a common nutritional supplement (NS), which is regularly used to help toddlers (ages 12-36 months) gain weight. This study will look at whether GUF helps to increase solid food intake for children who are thought to be "picky eaters" and see the effects on growth compared with the NS. To date, it is not clear if GUFs help to increase intake of solid foods. Participants will be placed into one of the two study arms: Enfagrow (GUF) or Pediasure (standard NS).

Study Overview

• Status: Completed
• Conditions: Healthy Toddlers 12-36 Months of Age With Mild or Moderate Malnutrition
• Intervention / Treatment: Dietary supplement: Enfagrow® Neuropro Toddler Nutritional Drink; Dietary supplement: Pediasure® Grow & Gain Protein Shake for Kids

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 3 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Healthy toddlers 12-36 months of age with mild or moderate malnutrition will be defined by at least one of the following indicators:

1. Weight-for-length z-score between -1.0 and -2.9 for children less than 2 years of age using the WHO growth standards; or
2. BMI z-score between -1 to -2.9 for children between 2 and 3 years of age using the CDC growth standards; or
3. Middle upper-arm circumference (MUAC) z-scores between -1 to -2.9 using the WHO growth references; or
4. Percentage of median ideal body weight of 70-89% (using the 50th percentile of the aforementioned growth standards).

Exclusion Criteria:

• Toddlers currently on or with history of tube feeding or with chronic health conditions that influence eating (e.g., food allergies, genetic disorders or developmental disabilities, oral motor difficulties that require sensory or feeding therapy).
• Toddlers who were born at less than 34 weeks gestation, as they may have lingering feeding challenges.
• Toddlers with gastroesophageal reflux disease (GERD) requiring medications or hydrolyzed formula or any type of esophageal disorders will be excluded.
• Toddlers with a history of infant reflux will not be excluded. The PI will make this distinction after a detailed history and record review.
• Families who do not speak English or Spanish in the home.
• Toddlers with suspected malabsorption or conditions that increased metabolic demands such as congenital heart defects.
• Toddlers who have a diagnosed allergy to cow's milk.

The PI will use their clinical discretion to ascertain patient eligibility.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Growing Up Formula (GUF)	Dietary supplement: Enfagrow® Neuropro Toddler Nutritional Drink; Enfagrow® Neuropro Toddler Nutritional Drink to be consumed per day (equivalent to 40 mL per kg, rounded to the nearest ounce)
Active Comparator: Standard Nutritional Supplement (NS)	Dietary supplement: Pediasure® Grow & Gain Protein Shake for Kids; Pediasure® Grow & Gain Protein Shake for Kids to be consumed per day (equivalent to 40 mL per kg, rounded to the nearest ounce)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dietary intake from solid foods - Total proteins in grams	Amount of intake of food groups from age-appropriate solid foods;; Intake of calories from age-appropriate solid foods;; Intake of micronutrients from age-appropriate solid foods;; Proportion of calories consumed from age-appropriate solid foods compared with the assigned supplement;; Proportion of micronutrients consumed from age-appropriate solid foods compared with the assigned supplement	At baseline
Dietary intake from solid foods - Total grains in grams	Amount of intake of food groups from age-appropriate solid foods;; Intake of calories from age-appropriate solid foods;; Intake of micronutrients from age-appropriate solid foods;; Proportion of calories consumed from age-appropriate solid foods compared with the assigned supplement;; Proportion of micronutrients consumed from age-appropriate solid foods compared with the assigned supplement	At baseline
Dietary intake from solid foods - Total vegetables in cups	Amount of intake of food groups from age-appropriate solid foods;; Intake of calories from age-appropriate solid foods;; Intake of micronutrients from age-appropriate solid foods;; Proportion of calories consumed from age-appropriate solid foods compared with the assigned supplement;; Proportion of micronutrients consumed from age-appropriate solid foods compared with the assigned supplement	At baseline
Dietary intake from solid foods - Total proteins in grams	Amount of intake of food groups (total proteins in grams, total grains in grams) from age-appropriate solid foods;; Intake of calories from age-appropriate solid foods;; Intake of micronutrients from age-appropriate solid foods;; Proportion of calories consumed from age-appropriate solid foods compared with the assigned supplement;; Proportion of micronutrients consumed from age-appropriate solid foods compared with the assigned supplement	At 3 months
Dietary intake from solid foods - Total grains in grams	Amount of intake of food groups from age-appropriate solid foods;; Intake of calories from age-appropriate solid foods;; Intake of micronutrients from age-appropriate solid foods;; Proportion of calories consumed from age-appropriate solid foods compared with the assigned supplement;; Proportion of micronutrients consumed from age-appropriate solid foods compared with the assigned supplement	At 3 months
Dietary intake from solid foods - Total vegetables in cups	Amount of intake of food groups from age-appropriate solid foods;; Intake of calories from age-appropriate solid foods;; Intake of micronutrients from age-appropriate solid foods;; Proportion of calories consumed from age-appropriate solid foods compared with the assigned supplement;; Proportion of micronutrients consumed from age-appropriate solid foods compared with the assigned supplement	At 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Outcomes Measures Related to Growth and Nutrition	Change in micronutrient status between baseline and month 3 as assessed through circulating micronutrient status, measured by laboratory assessment: CBC, Ferritin, sed rate, zinc, DHA, and vitamin D	Change from baseline to 3 months
Secondary Outcomes Measures Related to Growth and Nutrition -- Weight gain	Nutrition status assessment - Change in weight Weight gain: catch up growth is defined by weight gain of >6 g per day[	Change from baseline to 3 months

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Children's Hospital Colorado; Mead Johnson Nutrition
• Investigators: Principal Investigator: Liliane Diab, MD, Children's Hospital Colorado

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2021
• Primary Completion (Actual): November 1, 2024
• Study Completion (Actual): December 1, 2024

Study Registration Dates

• First Submitted: September 3, 2021
• First Submitted That Met QC Criteria: October 8, 2021
• First Posted (Actual): October 22, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 13, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: 20-3082

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No