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Tolerance of an Oral Nutritional Supplement(ONS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT01782456
First received: January 31, 2013
Last updated: May 30, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Gastro-Intestinal Tolerance
Other: Study Oral Nutritional Supplement

Study Type: Interventional
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 ]

Enrollment: 25
Study Start Date: March 2013
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   3 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01782456

Locations
United States, Ohio
Radiant Research, Inc.
Cincinnati, Ohio, United States, 45249
Sponsors and Collaborators
Abbott Nutrition
Investigators
Study Chair: Jennifer Williams, MPH Abbott Nutrition
  More Information

No publications provided

Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT01782456     History of Changes
Other Study ID Numbers: AL09
Study First Received: January 31, 2013
Last Updated: May 30, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 25, 2014