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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Parental Notions and Clinical Experiences About Child's Gut Comfort, Overall Satisfaction and Sense of Well-being When Consuming a New Toddler Milk

NCT04768933

Digestion Happiness Temperament

COMPLETED NA

Oral Nutritional Supplementation in Children With Growth Concerns

NCT07312201

Growth Toddlers Attention +1 more

NOT_YET_RECRUITING NA

Toddler Milk Intervention Trial

NCT02907502

Healthy

COMPLETED NA

Nutrition Intervention of Complementary Milk Feeding to Improve Linear Growth of at Risk and Stunted Children

NCT05670002

At Risk or Stunted Children

COMPLETED NA

Effect of a Hydrolyzed Rice Protein-based Formula on Growth, Tolerance, and Health-related Quality of Life in Infants With Cow's Milk Protein Allergy.

NCT06633250

Cow Milk Protein Allergy

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Picky Eating Behaviors

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

nutritional counseling

Group Type OTHER

nutritional counseling

Intervention Type OTHER

nutritional counseling

nutritional counseling and milk-based supplement

nutritional counseling plus oral milk-based nutrition supplement

Group Type OTHER

nutrition counseling plus oral milk-based nutritional supplement

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIETARY_SUPPLEMENT

nutritional counseling

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

30 Months

Maximum Eligible Age

60 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No