Oral Nutritional Supplementation in Children at Risk of Undernutrition

Inclusion Criteria:

• Child is 36 months - 107 months of age.

• Child is undernourished as determined by BMI for age z-score or Mid-upper-armcircumference 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 anyparticipation in the study.

• Child's caregiver is willing to abstain from providing non-study oral nutritionsupplements during the study period duration.

• Child's caregiver is able and willing to follow study procedures and record data inparent 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, ifrandomized to intervention group

Exclusion Criteria:

• Child has a height-for-age z-score ≥ 0.

• Child is currently drinking an oral nutritional supplement (ONS) on a regular basis (≥ 15 days in the past month)

• Child is participating in another study that has not been approved as a concomitantstudy by AN.

• Child has been diagnosed with the following:

• Galactosemia, or an allergy or intolerance to any ingredient found in the studyproduct

• Acute or chronic infections including but not restricted to respiratoryinfections, diarrhea, Hepatitis B or C, HIV infection or tuberculosis

• Severe gastrointestinal disorders such as celiac disease, short bowel syndrome,pancreatic insufficiency, or cystic fibrosis

• Neoplastic, renal, hepatic or cardiovascular, hormonal or metabolic disorders,Down's syndrome or significant, uncorrected cardiac anomalies that may impactgrowth

• Infantile anorexia nervosa, developmental disability, including physicaldisorders such as cerebral palsy, or a developmental delay that is consideredtoo severe for participation

• Disorders of hemoglobin structure, function or synthesis

• Clinically significant nutritional deficiency requiring specialty nutritionaltherapy

• Any other clinically significant medical condition, which in the investigator'sopinion, makes him or her unsuitable for inclusion in the study.