Tolerance of an Oral Nutritional Supplement(ONS)

Gastro-Intestinal Tolerance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01782456
• Other study ID #: AL09
• Status: Completed
• Phase: N/A
• First received: January 31, 2013
• Last updated: May 30, 2013
• Start date: March 2013
• Est. completion date: April 2013

Study information

• Verified date: May 2013
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 10 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Gastro-Intestinal Tolerance

Intervention

Other:
• Study Oral Nutritional Supplement
Supplement contains a new protein mix consisting of a blend of milk, soy, and pea protein.

Locations

Country	Name	City	State
United States	Radiant Research, Inc.	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastro-Intestinal Tolerance	Self-reported Questionnaire	Study Day 1-7	No
Secondary	Study Supplement Compliance	Self-reported number of servings consumed per day	Study Day 1-7	No
Secondary	Weight		Study Day 1 and 8	No
Secondary	Height		Study Day 1 and 8	No