Oral Nutritional Supplementation in Picky Eating Children

Study Objective:

To investigate the effect of two oral nutritional supplements (ONS) along with dietary counseling vs dietary counseling alone on growth among picky eating children from India, aged > 24 months to ≤ 48 months over a period of 90 days.

Number of Subjects / Length of Participation:

Approximately 321 subjects (107 subjects per group) will be enrolled from estimated 8-10 study centers to obtain at least 255 evaluable subjects (85 subjects per group), assuming 20% attrition rate. Expected total duration for the study is approximately 12 months.

Study Design :

• Prospective, randomized, double blinded study, with two parallel treatment groups and an open-labeled control group multicenter clinical study Eligible subjects will be randomized into three groups
• Experimental Group 1: Oral nutritional supplement and dietary counseling. (List No S691/Z0)
• Experimental Group 2: Oral nutritional supplement and dietary counseling. (List No- P968/Z0)
• Control Group: Dietary counseling.

Inclusion criteria

• Child is > 24 months and ≤ 48 months of age at visit 1.
• Child of either gender (Male and Female).
• Child has a weight-for-height between 3rd - 15th percentiles according to current WHO Growth Charts at visit 1. (WHO Growth Chart 2007)
• Child is a picky eater, defined as meeting at least two of the following criteria. A child, who:

• eats only a limited number of foods
• is unwilling to try new foods
• refuses to eat vegetables and/or foods from other food groups
• shows strong food likes and dislikes
• has behaviors that disrupt mealtime
• Child is a habitual milk drinker at least 1 glass (approximately 200mL) of milk daily.
• Child is able to consume foods and beverages orally.
• Child's Legal Guardian (LG) or parent(s) is willing to abstain from giving additional non-study nutritional supplements including vitamin/mineral supplements, micronutrient fortified beverages, oral nutritional supplements other than the study product during the study intervention period.
• Child's Legal Guardian (LG) or parent(s) has voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) prior to any participation in the study.
• Child's Legal Guardian (LG) or parent(s) 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 Legal Guardian (LG) or parent(s)is not planning to relocate during the study period

Exclusion criteria

• Child has been diagnosed with Lactose Intolerance & Galactosemia according to medical records or Legal Guardian (LG) /parent report.
• Child has been diagnosed or is known to be allergic or intolerant to any ingredient found in the study product according to medical records or Legal Guardian (LG)/parent report.
• Child has a current acute or chronic infection including respiratory infection, diarrhea, acute or chronic, Hepatitis B or C, HIV infection or tuberculosis according to medical records or Legal Guardian (LG)/parent report.
• Child has been diagnosed with presence of severe gastrointestinal disorders including celiac disease, short bowel syndrome, pancreatic insufficiency, or cystic fibrosis according to medical records or Legal Guardian (LG)/parent report.
• Child has been diagnosed with neoplastic, renal, hepatic or cardiovascular disease according to medical records or Legal Guardian (LG) /parent report.
• Child has been diagnosed with hormonal or metabolic disorders according to medical records or Legal Guardian (LG) /parent report.
• Child has been diagnosed with congenital disease or genetic disorders such as atrial or ventricular wall defects, or Down's syndrome according to medical records or Legal Guardian (LG) /parent report.
• Child has been diagnosed with infantile anorexia nervosa according to medical records or Legal Guardian (LG) /parent report.
• Child has been diagnosed with a developmental disability, including physical disorders such as cerebral palsy, or developmental delay according to medical records or Legal Guardian (LG) /parent report.
• Child has been diagnosed with disorders of hemoglobin structure, function or synthesis according to medical records or Legal Guardian (LG) /parent report.
• Child has a clinically significant nutritional deficiency requiring specific treatment with another nutritional supplement (other than the study product) as diagnosed by the investigator.
• Child has any other clinically significant medical condition, which in the investigator's opinion, makes him or her unsuitable for inclusion in the study.