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

NCT01823302 | Completed Phase 4

• 1 other identifier: 9601A1-4000
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 2

Brief 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

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Effect of a new growing-up milk on growth and nutrient adequacy in children with picky-eating behaviors

  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 Outcomes (4)

• Effect of a new growing-up milk on growth and nutrient adequacy in children with picky-eating behaviors

  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

  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

  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

Study Arms (2)

nutritional counseling

OTHER

nutritional counseling

Other: nutritional counseling

nutritional counseling and milk-based supplement

OTHER

nutritional counseling plus oral milk-based nutrition supplement

Dietary Supplement: nutrition counseling plus oral milk-based nutritional supplement

Interventions

nutrition counseling plus oral milk-based nutritional supplement DIETARY_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.

nutritional counseling and milk-based supplement

nutritional counseling OTHER

nutritional counseling

nutritional counseling

Eligibility Criteria

• Age: 30 Months - 60 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (2)

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

Location

Xinhua Hospital Affiliated to Shanghai Jiaotong

Shanghai, Shanghai Municipality, 200092, China

Location

MeSH Terms

Interventions

Nutrition Assessment

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Xiaoyang Sheng, Professor

  Xinhua Hospital Affiliated to Shanghai Jiaotong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2013
• First Posted: April 4, 2013
• Study Start: February 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: April 4, 2013

Record last verified: 2013-03

Locations

CN (2)