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

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.

Study Overview

• Status: Completed
• Conditions: Picky Eating Behaviors
• Intervention / Treatment: Other: nutritional counseling; Dietary supplement: nutrition counseling plus oral milk-based nutritional supplement

• Study Type: Interventional
• Enrollment (Actual): 165
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200092
      • Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine
    • Shanghai, Shanghai, China, 200092
      • Xinhua Hospital Affiliated to Shanghai Jiaotong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children aged 30-60 months with PE behavior as reported by caregivers and whose weight-for-height was ≤25th percentile according to World Health Organization (WHO) Child Growth Standards were eligible for inclusion.

Exclusion Criteria:

• Current acute or chronic illness, food allergies, lactose intolerance, dietary restrictions precluding dairy foods, any genetic disorder that may compromise growth and/or food intake, cognitive or developmental disorders, or medications that may influence study outcomes.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: nutritional counseling	Other: nutritional counseling; nutritional counseling
Other: nutritional counseling and milk-based supplement; nutritional counseling plus oral milk-based nutrition supplement	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of a new growing-up milk on growth and nutrient adequacy in children with picky-eating behaviors	The primary efficacy evaluation was growth, including the change in weight-for-height z-score from baseline to Day 120, as well as from baseline to Days 30, 60 and 90, and over the entire study period based on repeated measures analysis.	baseline to Day 120, as well as from baseline to Days 30, 60 and 90, and over the entire study period based on repeated measures analysis.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of a new growing-up milk on growth and nutrient adequacy in children with picky-eating behaviors	Secondary efficacy evaluations included: dietary macro- and micro-nutrient intakes, quantitative ultrasound measurements of the radius and tibia, and incidence of common illnesses (diarrhea, and upper and lower respiratory tract infection).	baseline to Day 120, as well as from baseline to Days 30, 60 and 90, and over the entire study period based on repeated measures analysis.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of a new growing-up milk on growth and nutrient adequacy in children with picky-eating behaviors	Safety was evaluated through the recording and monitoring of adverse events.	baseline to Day 120, as well as from baseline to Days 30, 60 and 90, and over the entire study period based on repeated measures analysis.
•Effect of a new growing-up milk on growth and nutrient adequacy in children with picky-eating behaviors	dietary macro- and micro-nutrient intakes	baseline to Day 120, as well as from baseline to Days 30, 60 and 90, and over the entire study period based on repeated measures analysis
•Effect of a new growing-up milk on growth and nutrient adequacy in children with picky-eating behaviors	quantitative ultrasound measurements of the radius and tibia	baseline to Day 120, as well as from baseline to Days 30, 60 and 90, and over the entire study period based on repeated measures analysis
•Effect of a new growing-up milk on growth and nutrient adequacy in children with picky-eating behaviors	and incidence of common illnesses (diarrhea, and upper and lower respiratory tract infection).	baseline to Day 120, as well as from baseline to Days 30, 60 and 90, and over the entire study period based on repeated measures analysis

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)
• Investigators: Principal Investigator: Xiaoyang Sheng, Professor, Xinhua Hospital Affiliated to Shanghai Jiaotong

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: March 21, 2013
• First Submitted That Met QC Criteria: March 28, 2013
• First Posted (Estimate): April 4, 2013

Study Record Updates

• Last Update Posted (Estimate): April 4, 2013
• Last Update Submitted That Met QC Criteria: March 28, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: Children with picky-eating behaviors; Children aged 2.5 - 5 years; reported by caregivers; with weight-for-height z-scores ≤ 25th percentile at enrollment
• Other Study ID Numbers: 9601A1-4000