Tolerance of an Oral Nutritional Supplement(ONS)

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

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 Overview

• Status: Completed
• Conditions: Gastro-Intestinal Tolerance
• Intervention / Treatment: Other: Study Oral Nutritional Supplement

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45249
      • Radiant Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 10 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Abbott Nutrition

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: January 31, 2013
• First Submitted That Met QC Criteria: January 31, 2013
• First Posted (Estimate): February 4, 2013

Study Record Updates

• Last Update Posted (Estimate): June 3, 2013
• Last Update Submitted That Met QC Criteria: May 30, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: AL09