Tolerance of an Oral Nutritional Supplement(ONS)

Study Overview
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Brief Summary
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The objective of this study is to capture information on gastrointestinal tolerance (GI) of an oral nutritional supplement containing a new protein blend in healthy children aged ≥ 3 to ≤ 10 years.

Official Title
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Tolerance of an Oral Nutritional Supplement(ONS)With a New Protein Blend in Healthy Children

Conditions
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Gastro-Intestinal Tolerance

Intervention / Treatment
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* Other: Study Oral Nutritional Supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 3 and ≤ 10 years of age Healthy and not suffering from any physical disability. Height-for-age and BMI-for-age between the 5th and the 95th percentile as well as a weight-for-age between the 5th and the 85th percentile Consumption of 2 servings/day of the investigational product for 7 consecutive days Willingness to follow the study procedures and record the data in the diary and complete any forms or assessment as needed throughout the study Agreement to not consume a nutritional product that is not study product during the study period Exclusion Criteria: History of an acute or chronic condition that may affect feeding habits or nutritional status Medications or nutritional supplements, taken on a daily basis for more than 2 weeks during the past month prior to screening visit that may profoundly affect feeding habits or nutritional status Clinically significant nutritional deficiency requiring specific treatment Acute/chronic condition requiring medical treatment which may include hospitalization such as diabetes or stress induced hyperglycemia, dialysis treatment, inflammatory bowel disease, pancreatitis, autoimmune disease or immunodeficiency, celiac disease, cystic fibrosis, active tuberculosis, malformation of the gastrointestinal tract or gastroesophageal reflux disease History of constipation Allergy or intolerance to any ingredient in the study product Gastrointestinal infection or acute diarrhea at the time of study start Hepatitis B or C, or HIV, or malignancy Congenital cardiac defects Antibiotic therapy within last 2 weeks of start of study Dysphagia, aspiration risk, difficulty in swallowing due to acquired/congenital abnormalities

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 10 Years

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

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Oral Nutritional Supplement<br>2 servings per day of a complete and balanced, ready-to-drink oral nutritional supplement with a new protein blend. | Other: Study Oral Nutritional Supplement<br>* Supplement contains a new protein mix consisting of a blend of milk, soy, and pea protein.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastro-Intestinal Tolerance | Self-reported Questionnaire | Study Day 1-7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study Supplement Compliance | Self-reported number of servings consumed per day | Study Day 1-7 | 
| Weight |  | Study Day 1 and 8 | 
| Height |  | Study Day 1 and 8 |