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

NCT01823302 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2013-04-04

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Société des Produits Nestlé (SPN)

    lead INDUSTRY

Principal Investigators

  • Xiaoyang Sheng, Professor · Xinhua Hospital Affiliated to Shanghai Jiaotong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Months
Max Age
60 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01823302 on ClinicalTrials.gov