Effects of Oral Nutritional Supplementation in Children at Risk of Undernutrition

Inclusion criteria

• Children 24-60 months old
• Undernourished or at risk of undernutrition according to the WHO Growth Standards.
• Child's parent(s)/legal guardian (LG) is willing to abstain from giving additional non-study ONS other than the study product during the study intervention period.
• Child's parent(s)/LG is able and willing to follow study procedures and record data in parent diary and complete any forms or assessments needed throughout the study.
• Child's parent(s)/LG is not planning to relocate during the study period.
• Child's parent(s)/LG has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) or other applicable privacy regulation authorization prior to any participation in the study.

Exclusion criteria

• Participant participates in another study that has not been approved as a concomitant study.
• Child is known to have galactosemia, be allergic or intolerant to any ingredient found in the study product.
• Child is currently drinking an Abbott product(s).
• Child had a history of preterm delivery, defined as a birth before 37 completed weeks of gestation as reported by parent(s)/LG.
• Child had birth weight < 2500 g or > 4000 g.
• Child whose either parent has BMI ≥ 27.5 kg/m2
• Child has continuous oral nutrition supplement (ONS) usage for at least 15 days in the past 1 month prior to screening. The standard ONS formula usually has an energy density of at least 1 kcal/mL, containing protein, carbohydrate and/or fat, as well as a wide range of micronutrients to supplement or use as the sole source of nutrition.
• Child has current acute or chronic infections including but not restricted to respiratory infections, diarrhea, acute and chronic Hepatitis B or C, HIV infection or tuberculosis.
• Child has been diagnosed with the following according to medical records or report by parent(s)/LG or the clinician's judgment:

• Severe gastrointestinal disorders such as celiac disease, short bowel syndrome, pancreatic insufficiency, or cystic (Exception: Intestinal parasites infection)
• Neoplastic, renal, hepatic or cardiovascular, hormonal or metabolic disorders, congenital disease or genetic disorders such as atrial or ventricular wall defects, Down's syndrome, or thalassemia
• Infantile anorexia nervosa, developmental disability, including physical disorders such as cerebral palsy, or developmental delay
• Disorders of hemoglobin structure, function or synthesis
• Clinically significant nutritional deficiency requiring specific treatment with another nutritional supplement (other than the study product) as diagnosed by the investigator.
• Any other clinically significant medical condition, which in the investigator's opinion, makes him or her unsuitable for inclusion in the study.