Summary:
The objective of this randomized, controlled trial is to evaluate the effects of consuming a pediatric oral nutritional supplement (ONS) plus dietary counseling for 120 days on anthropometric growth, strength, and nutritional status, compared with dietary counseling alone in undernourished children in the United States.
Inclusion Criteria:
- Child is 36 months - 107 months of age.
- Child is undernourished as determined by BMI for age z-score or Mid-upper-arm circumference z-score
- Child's caregiver has voluntarily signed and dated an informed consent form (ICF), approved by an IRB, and provided Health Insurance Portability and Accountability Act (HIPAA) or other applicable privacy regulation authorization prior to any participation in the study.
- Child's caregiver is willing to abstain from providing non-study oral nutrition supplements during the study period duration.
- Child's caregiver is able and willing to follow study procedures and record data in parent diaries and complete any forms or assessments needed during the study.
- Child is willing to consume the study product for the duration of the study, if randomized to intervention group
Qualified Participants May Receive:
Compensation available for time and travel.