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

NCT05088590 | Completed

• 1 other identifier: 20-3082
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Healthy Toddlers 12-36 Months of Age With Mild or Moderate Malnutrition

Outcome Measures

Primary Outcomes (6)

• Dietary intake from solid foods - Total proteins in grams

  1. Amount of intake of food groups from age-appropriate solid foods; 2. Intake of calories from age-appropriate solid foods; 3. Intake of micronutrients from age-appropriate solid foods; 4. Proportion of calories consumed from age-appropriate solid foods compared with the assigned supplement; 5. 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

  1. Amount of intake of food groups from age-appropriate solid foods; 2. Intake of calories from age-appropriate solid foods; 3. Intake of micronutrients from age-appropriate solid foods; 4. Proportion of calories consumed from age-appropriate solid foods compared with the assigned supplement; 5. 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

  1. Amount of intake of food groups from age-appropriate solid foods; 2. Intake of calories from age-appropriate solid foods; 3. Intake of micronutrients from age-appropriate solid foods; 4. Proportion of calories consumed from age-appropriate solid foods compared with the assigned supplement; 5. 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

  1. Amount of intake of food groups (total proteins in grams, total grains in grams) from age-appropriate solid foods; 2. Intake of calories from age-appropriate solid foods; 3. Intake of micronutrients from age-appropriate solid foods; 4. Proportion of calories consumed from age-appropriate solid foods compared with the assigned supplement; 5. 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

  1. Amount of intake of food groups from age-appropriate solid foods; 2. Intake of calories from age-appropriate solid foods; 3. Intake of micronutrients from age-appropriate solid foods; 4. Proportion of calories consumed from age-appropriate solid foods compared with the assigned supplement; 5. 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

  1. Amount of intake of food groups from age-appropriate solid foods; 2. Intake of calories from age-appropriate solid foods; 3. Intake of micronutrients from age-appropriate solid foods; 4. Proportion of calories consumed from age-appropriate solid foods compared with the assigned supplement; 5. Proportion of micronutrients consumed from age-appropriate solid foods compared with the assigned supplement

  At 3 months

Secondary Outcomes (2)

• Secondary Outcomes Measures Related to Growth and Nutrition

  Change from baseline to 3 months

• Secondary Outcomes Measures Related to Growth and Nutrition -- Weight gain

  Change from baseline to 3 months

Study Arms (2)

Growing Up Formula (GUF)

EXPERIMENTAL

Dietary Supplement: Enfagrow® Neuropro Toddler Nutritional Drink

Standard Nutritional Supplement (NS)

ACTIVE COMPARATOR

Dietary Supplement: Pediasure® Grow & Gain Protein Shake for Kids

Interventions

Enfagrow® Neuropro Toddler Nutritional Drink DIETARY_SUPPLEMENT

Enfagrow® Neuropro Toddler Nutritional Drink to be consumed per day (equivalent to 40 mL per kg, rounded to the nearest ounce)

Growing Up Formula (GUF)

Pediasure® Grow & Gain Protein Shake for Kids DIETARY_SUPPLEMENT

Pediasure® Grow \& Gain Protein Shake for Kids to be consumed per day (equivalent to 40 mL per kg, rounded to the nearest ounce)

Standard Nutritional Supplement (NS)

Eligibility Criteria

• Age: 12 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Healthy toddlers 12-36 months of age with mild or moderate malnutrition will be defined by at least one of the following indicators:
• 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
• BMI z-score between -1 to -2.9 for children between 2 and 3 years of age using the CDC growth standards; or
• Middle upper-arm circumference (MUAC) z-scores between -1 to -2.9 using the WHO growth references; or
• Percentage of median ideal body weight of 70-89% (using the 50th percentile of the aforementioned growth standards).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Children's Hospital Colorado: collaborator
• Mead Johnson Nutrition: collaborator

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Study Officials

• Liliane Diab, MD

  Children's Hospital Colorado

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: October 22, 2021
• Study Start: August 27, 2021
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)