Oral Nutritional Supplementation in Children

Study Overview
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Brief Summary
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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.

Official Title
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Oral Nutritional Supplementation in Children With Picky Eating Behaviors

Conditions
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Children

Intervention / Treatment
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* Other: Nutritional Supplement and Counseling
* Other: Counseling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 36 Months
Maximum Age: 109 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |