Oral Nutritional Supplementation in Children

Oral Nutritional Supplementation in Children With Picky Eating Behaviors

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.

Study Overview

• Status: Terminated
• Conditions: Children
• Intervention / Treatment: Other: Nutritional Supplement and Counseling; Other: Counseling

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68516
      • Midwest Children's Health Research Institute
  • Ohio
    • Cincinnati, Ohio, United States, 45249
      • Radiant Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 9 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. ≥ 36 months and < 109 months of age.
2. Healthy and not suffering from any physical disability.
3. Height-for-age and BMI-for-age between the 5th and the 95th percentile; weight-for-age between the 5th and the 85th percentile.
4. Capable of oral feeding.
5. 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).
6. Willing to abstain from consuming non-study nutritional supplements during the study intervention period.

Exclusion Criteria:

1. History of an acute or chronic condition that may affect feeding habits or nutritional status.
2. 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.
3. Clinically significant nutritional deficiency requiring specific treatment with any other nutritional supplement.
4. Any acute/chronic condition requiring medical treatment which may include hospitalization.
5. Allergy or intolerance to any ingredient in the study product.
6. Gastrointestinal infection, acute constipation or acute diarrhea.
7. Hepatitis B or C, or HIV, or malignancy.
8. Congenital cardiac defects.
9. Dysphagia, aspiration risk or difficulty in swallowing due to acquired/congenital abnormalities.
10. 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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nutritional Supplement and Counseling; Two servings a day; ready-to-feed nutritional supplement plus dietary counseling	Other: Nutritional Supplement and Counseling; Ready-to-feed nutritional supplement and dietary counseling
Active Comparator: Counseling; Dietary Counseling	Other: Counseling; Dietary counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Vitamin D Intake	Change from Baseline to Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Macronutrient Intake	24-hour dietary recall interview	Change from Baseline to Week 4
Micronutrient Intake	24-hour dietary recall interview	Change from Baseline to Week 4

Collaborators and Investigators

• Sponsor: Abbott Nutrition

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: April 24, 2014
• First Submitted That Met QC Criteria: April 28, 2014
• First Posted (Estimate): April 29, 2014

Study Record Updates

• Last Update Posted (Estimate): July 27, 2015
• Last Update Submitted That Met QC Criteria: July 24, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: AL15