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

Nestlé

Status and phase

Completed

Phase 4

Conditions

Picky Eating Behaviors

Treatments

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

Other: nutritional counseling

Study type

Interventional

Funder types

Industry

Identifiers

NCT01823302

9601A1-4000

Details and patient eligibility

About

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.

Enrollment

165 patients

Sex

All

Ages

30 to 60 months old

Volunteers

No Healthy Volunteers

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.