2.1. Study Design and Participants
This was a multi-centric prospective randomized double-blinded study with two parallel treatment groups and an open-labelled control group. It was conducted in order to examine the impact of oral nutritional supplementation on growth and nutrient intake in picky-eating children between 24 and 48 months of age. The study was conducted in 10 hospitals and clinics in different cities in India. The intervention lasted for a period of 90 days and the entire duration of the study was approximately 12 months (i.e., between June 2016 and February 2017). Data on anthropometry (weight, height, and mid-upper-arm circumference) and dietary intake were collected at five time points, viz., Days 1 (Baseline), 7, 30, 60, and 90. Appetite score, palatability, and compliance were also recorded for each subject during each visit.Two types of supplements were given to the children: (1) ONS1, a milk-based supplement, and (2) ONS2, a lactose-free supplement (manufactured by PediaSure and PediaSure Advance, respectively, at Abbott Healthcare Private Limited, Mumbai, India). These contained three macronutrients with matching levels of protein (at 12% of energy), 28 vitamins and minerals, and the prebiotic fiber fructo-oligosaccharide (FOS). The fat energy percent was higher, and the carbohydrate energy percent was lower, in ONS2 than in ONS1 (A total of 321 children, who had weight-for-height was between the 3rd and 15th percentiles according to the current WHO Growth Charts (2006) [All three groups received dietary counselling. Dietary counselling on the consumption of a balanced diet, the inclusion of a variety of foods in a daily diet, improving diet quality, and improving appetite for meeting the nutrition requirements of a child were given by a trained dietitian at each visit. Compliance was assessed via diary records kept by the parents/guardians; children were considered compliant if they had consumed at least 75% of the recommended ONS intake. Anthropometric measurements of weight, height, body mass index (BMI), and mid-upper-arm circumference (MUAC) were taken on Days 1, 30, 60, and 90 for all three groups by study staff who had been trained to use standardized methods. The data on changes in growth from Day 1 to Day 90 were assessed using various anthropometric indicators, and have been reported in our earlier publication [