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

Société des Produits Nestlé (SPN)165 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

165

Conditions

Picky Eating Behaviors

Interventions

Eligibility

Sex: ALLMin age: 30 MonthsMax age: 60 Months

Medical Language ↔ Plain English

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.

Locations (2)

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Xinhua Hospital Affiliated to Shanghai Jiaotong

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

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.

Time frame: 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 Outcomes

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).

Time frame: 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.