Abstract
OBJECTIVES: This was a multicenter prospective randomized double-blind study with two parallel experimental groups (EXP GRPS) & an open-labeled control grp (CON). Objective was to investigate the effect of two oral nutritional supplements (ONS) along with dietary counseling (DC) vs DC alone on growth among picky eating children from India, aged > 24 m to ≤ 48 m over 90 days. METHODS: Study recruited 321 children [n = 107/grp] in ages mentioned above from urban/semi-urban India with a weight-for-height between 3(rd)–15(th) centile (WHO 2006) and picky eating behaviors. Subjects in the 2 EXP GRPS received a daily supplement of one of the two similar ONS [Pediasure (PDS) & Pediasure Advance (PDS Adv)} along with DC for 90 days, whereas subjects in CON received only DC. Children in both EXP GRPS consumed min of 1 & max to 2 servings of ONS/day & there were 5 study visits (Day 1, 7, 30, 60, 90). Primary variable was the change in WHO weight-for-height centile from Day 1 to 90. Secondary variables included change in weight-for-age, height-for-age, BMI-for-age, MUAC-for-age, average intake of energy, macros & micronutrients (using 24 hr. dietary recall) and change in appetite & palatability score. RESULTS: Post 90 days, both EXP GRPS had significantly higher change in growth parameters like weight-for-height centile (P = 0.0086), BMI-for-age centile (P = 0.0214 & P = 0.0203 for PDS & PDS Adv respectively) & weight-for-age centile (P = 0.0054) as compared to CON. PDS group reported a significant improvement in MUAC-for-age centile (P = 0.0241) vs CON post 90-days. Significant improvement in appetite score was reported by EXP GRPS (P = 0.0067 & P = 0.0245 for PDS & PDS Adv) vs CON. Significant improvement in avg. intake of energy, protein, fat, calcium, iron, vit C & thiamine was observed for EXP GRPS vs CON for all visit days except day1. Nutrient & energy intakes at baseline were lower than RDA's but ONS helped to fill the nutritional gaps at end of 90 days. There were no significant differences observed in the height-for-age and palatability score. CONCLUSIONS: ONS's formulated with macro & micronutrients along with DC are more efficacious in catch up growth vs DC alone post 90 days supplementation. FUNDING SOURCES: Abbott Nutrition has funded this study.