Growing Up Formula vs Nutritional Supplements for Toddler Malnutrition
(KEEP Growing Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a growing-up formula (GUF) can help picky eaters among toddlers consume more solid food compared to a common nutritional supplement (NS). Researchers will compare two products: Enfagrow, a GUF, and Pediasure, a standard NS, to assess their effects on weight gain and growth. The trial seeks toddlers aged 12-36 months with mild to moderate malnutrition, such as low weight-for-height or body mass index (BMI) that impacts daily life. As an unphased trial, this study provides a unique opportunity for parents to contribute to understanding nutritional solutions for toddler growth.
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications. However, toddlers with certain health conditions requiring medications, like GERD, are excluded from the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that both Enfagrow and Pediasure are generally safe for toddlers. Enfagrow supports growth and development by providing important nutrients and prebiotics. However, some studies suggest it might not be as healthy as claimed, and concerns have arisen about misleading information on its labels.
Pediasure has been studied in children who might not receive adequate nutrition. It contains protein, vitamins, and antioxidants to aid growth and support the immune system. Both products are designed to be safe for young children, but parents should be aware that health claims might not always be accurate.
Most toddlers can use these products without problems, but consulting a healthcare provider is advisable if there are any concerns.12345Why are researchers excited about this trial?
Researchers are excited about these treatments for toddler malnutrition because Enfagrow® Neuropro Toddler Nutritional Drink is designed to support brain development with nutrients like DHA and iron, which are not typically emphasized in standard nutritional supplements. On the other hand, Pediasure® Grow & Gain Protein Shake for Kids provides a balanced mix of protein, vitamins, and minerals aimed at overall growth and weight gain, which is crucial for toddlers struggling with malnutrition. These unique formulations could offer a more comprehensive approach to addressing both cognitive and physical development in young children, setting them apart from the usual options focused mainly on caloric intake.
What evidence suggests that this trial's treatments could be effective for toddler malnutrition?
This trial will compare the effectiveness of Enfagrow® Neuropro Toddler Nutritional Drink and Pediasure® Grow & Gain Protein Shake for Kids. Research has shown that Pediasure, a popular nutritional supplement, helps undernourished children gain weight and grow better. Studies have found that supplements like Pediasure can aid children at risk of malnutrition or who are picky eaters in growing. Pediasure has also been proven to support healthy growth, helping children gain muscle without excessive fat over four months.
For Enfagrow, which participants in this trial may receive, less specific research is available. However, it is designed to support brain development and fill nutritional gaps in toddlers. It contains 24 important nutrients to enhance a toddler's diet. While its effect on encouraging toddlers to eat more solid food remains unclear, it is made with real milk and fortified to support overall development in young children.25678Who Is on the Research Team?
Liliane Diab, MD
Principal Investigator
Children's Hospital Colorado
Are You a Good Fit for This Trial?
This trial is for toddlers aged 12-36 months with mild to moderate malnutrition, as indicated by specific growth measurements like weight-for-length or BMI z-scores. It's aimed at those who may not eat enough solid foods and need nutritional support.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either the Growing Up Formula (GUF) or the Standard Nutritional Supplement (NS) to assess effects on growth and solid food intake
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Enfagrow® Neuropro Toddler Nutritional Drink
- Pediasure® Grow & Gain Protein Shake for Kids
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor
Children's Hospital Colorado
Collaborator
Mead Johnson Nutrition
Industry Sponsor