Oral Nutritional Supplementation in Children With Picky Eating Behaviors

Abbott Nutrition2 sites in 1 country26 target enrollmentApril 2014

ConditionsChildren

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Children
Sponsor: Abbott Nutrition
Enrollment: 26
Locations: 2
Primary Endpoint: Vitamin D Intake
Status: Terminated
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study will investigate the effect of an oral nutritional supplement (ONS) along with dietary counseling on improving the dietary intake among children with picky eating behaviors.

Registry

clinicaltrials.gov

Start Date

April 2014

End Date

July 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Abbott Nutrition

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•≥ 36 months and \< 109 months of age.
•Healthy and not suffering from any physical disability.
•Height-for-age and BMI-for-age between the 5th and the 95th percentile; weight-for-age between the 5th and the 85th percentile.
•Capable of oral feeding.
•Has a mean score of greater than 3.0 on the fussiness category in the Children's Eating Behaviour Questionnaire and also consumes on average less than the daily recommendations for at least 3 of 5 food groups (Dietary Guidelines for America, 2010).
•Willing to abstain from consuming non-study nutritional supplements during the study intervention period.

Exclusion Criteria

•History of an acute or chronic condition that may affect feeding habits or nutritional status.
•Taking any medications or nutritional supplements on a daily basis for more than 2 weeks during the past month that may profoundly affect feeding habits or nutritional status.
•Clinically significant nutritional deficiency requiring specific treatment with any other nutritional supplement.
•Any acute/chronic condition requiring medical treatment which may include hospitalization.
•Allergy or intolerance to any ingredient in the study product.
•Gastrointestinal infection, acute constipation or acute diarrhea.
•Hepatitis B or C, or HIV, or malignancy.
•Congenital cardiac defects.
•Dysphagia, aspiration risk or difficulty in swallowing due to acquired/congenital abnormalities.
•Parent(s)/LG of the subject has any clinically significant medical disease or physical/psychological condition that may interfere with protocol adherence or ability of the parent(s)/LG to give informed consent.