Tolerance of an Oral Nutritional Supplement(ONS)

Not Applicable

Completed

• Conditions: Gastro-Intestinal Tolerance
• Interventions: Other: Study Oral Nutritional Supplement

• Registration Number: NCT01782456
• Lead Sponsor: Abbott Nutrition

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-31
• Study First Submitted QC: 2013-01-31
• Study First Posted: 2013-02-04
• Study Start: 2013-03
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-30
• Last Update Posted: 2013-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Oral Nutritional Supplement	Study Oral Nutritional Supplement	2 servings per day of a complete and balanced, ready-to-drink oral nutritional supplement with a new protein blend.

Primary Outcome Measures

Name	Time	Method
Gastro-Intestinal Tolerance	Study Day 1-7	Self-reported Questionnaire

Secondary Outcome Measures

Name	Time	Method
Study Supplement Compliance	Study Day 1-7	Self-reported number of servings consumed per day
Weight	Study Day 1 and 8
Height	Study Day 1 and 8

Trial Locations

Locations (1)

Radiant Research, Inc.; 🇺🇸 Cincinnati, Ohio, United States