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

Study Overview
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Brief Summary
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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.

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

Conditions
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Picky Eating Behaviors

Intervention / Treatment
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* Dietary Supplement: nutrition counseling plus oral milk-based nutritional supplement
* Other: nutritional counseling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Months
Maximum Age: 60 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: nutritional counseling<br>nutritional counseling | Other: nutritional counseling<br>* nutritional counseling<br>|
| Other: nutritional counseling and milk-based supplement<br>nutritional counseling plus oral milk-based nutrition supplement | Dietary Supplement: nutrition counseling plus oral milk-based nutritional supplement<br>* 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.<br>|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Children with picky-eating behaviors, Children aged 2.5 - 5 years, reported by caregivers, with weight-for-height z-scores ≤ 25th percentile at enrollment