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OpenTrials
Completed

NCT Number: NCT01782456

Tolerance of an Oral Nutritional Supplement(ONS)

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.

Completed

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Key information

Age range

3 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radiant Research, Inc.

Cincinnati, Ohio, 45249, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Study Oral Nutritional Supplement

Other

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

Primary outcomes

  1. Gastro-Intestinal Tolerance

    Time frame: Study Day 1-7

    Self-reported Questionnaire

Secondary outcomes

  1. Study Supplement Compliance

    Time frame: Study Day 1-7

    Self-reported number of servings consumed per day

  2. Weight

    Time frame: Study Day 1 and 8

  3. Height

    Time frame: Study Day 1 and 8

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 4, 2013
Registry last updated
Jun 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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