NCT01823302

Effect of a New Growing-up Milk on Growth and Nutrient Adequacy in Children With Picky-eating Behaviors

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 165 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 30 Months – 60 Months
• Healthy volunteers: Not accepted

Summary

The primary objective of the study was to compare the change in z-scores for growth during a 120-day study period in children with picky eating behaviors who were randomly assigned to receive nutrition counseling only (control group) or nutrition counseling plus an oral milk-based nutritional supplement (study group). The secondary objectives of the study were to compare the following between the control and study groups: a) dietary macro- and micro-nutrient intakes; b) quantitative ultrasound bone measurements of radius and tibia; and c) incidence of common illnesses (diarrhea, upper and lower respiratory tract). The safety objective of the study was to compare the frequency of adverse events (AE) among the control group and study group subjects.

Conditions

• Picky Eating Behaviors

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	nutrition counseling plus oral milk-based nutritional supplement	Study group subjects were instructed to consume at least 2 servings (230 mL per serving) of an oral milk-based nutritional supplement daily, in addition to their regular diet, for a total of 120 (±3) days.
OTHER	nutritional counseling	nutritional counseling

Timeline

• Start date: 2010-02-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2013-04-04
• Last updated: 2013-04-04

Locations

2 sites across 1 country: China