Tolerance of an Oral Nutritional Supplement(ONS)

NCT01782456 | Completed

• 1 other identifier: AL09
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastro-Intestinal Tolerance

Outcome Measures

Primary Outcomes (1)

• Gastro-Intestinal Tolerance

  Self-reported Questionnaire

  Study Day 1-7

Secondary Outcomes (3)

• Study Supplement Compliance

  Study Day 1-7

• Weight

  Study Day 1 and 8

• Height

  Study Day 1 and 8

Study Arms (1)

Study Oral Nutritional Supplement

EXPERIMENTAL

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

Interventions

Study Oral Nutritional Supplement OTHER

Supplement contains a new protein mix consisting of a blend of milk, soy, and pea protein.

Study Oral Nutritional Supplement

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (1)

Radiant Research, Inc.

Cincinnati, Ohio, 45249, United States

Location

Study Officials

• Jennifer Williams, MPH

  Abbott Nutrition

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2013
• First Posted: February 4, 2013
• Study Start: March 1, 2013
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: June 3, 2013

Record last verified: 2013-05

Locations

US (1)