Tolerance of an Oral Nutritional Supplement(ONS)
This study has been completed.
Information provided by (Responsible Party):
First received: January 31, 2013
Last updated: May 30, 2013
Last verified: May 2013
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Tolerance of an Oral Nutritional Supplement(ONS)With a New Protein Blend in Healthy Children|
Resource links provided by NLM:
Further study details as provided by Abbott Nutrition:
Primary Outcome Measures:
- Gastro-Intestinal Tolerance [ Time Frame: Study Day 1-7 ] [ Designated as safety issue: No ]Self-reported Questionnaire
Secondary Outcome Measures:
- Study Supplement Compliance [ Time Frame: Study Day 1-7 ] [ Designated as safety issue: No ]Self-reported number of servings consumed per day
- Weight [ Time Frame: Study Day 1 and 8 ] [ Designated as safety issue: No ]
- Height [ Time Frame: Study Day 1 and 8 ] [ Designated as safety issue: No ]
|Study Start Date:||March 2013|
|Study Completion Date:||April 2013|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Experimental: Study Oral Nutritional Supplement
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
Supplement contains a new protein mix consisting of a blend of milk, soy, and pea protein.
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