CClinicalTrials.gg
CompletedNCT01782456Updated Jun 3, 2013

Tolerance of an Oral Nutritional Supplement(ONS)

An interventional study of Study Oral Nutritional Supplement in Gastro-Intestinal Tolerance, sponsored by Abbott Nutrition. Completed at 1 site in United States. Open to participants aged 3 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-06-03.

Sponsored by Abbott Nutrition · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
3 Years to 10 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Gastro-Intestinal Tolerance
03

In context

Lead sponsor

Abbott Nutrition is the lead sponsor of 153 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • 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

Interventions

  • OtherStudy Oral Nutritional Supplement

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

06

What researchers measure

Primary outcomes

  1. Gastro-Intestinal Tolerance

    Self-reported Questionnaire

    Time frame: Study Day 1-7

Secondary outcomes

  1. Study Supplement Compliance

    Self-reported number of servings consumed per day

    Time frame: Study Day 1-7

  2. Weight

    Time frame: Study Day 1 and 8

  3. Height

    Time frame: Study Day 1 and 8

07

Study locations

1 site
  • Radiant Research, Inc.
    Cincinnati, Ohio 45249, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01782456
Lead sponsor
Abbott Nutrition
Responsible party
Sponsor
First posted
Feb 4, 2013
Start date
Mar 2013
Primary completion
Apr 2013
Completion
Apr 2013
Last update
Jun 3, 2013

Study contacts

Jennifer Williams, MPH
study chair · Abbott Nutrition

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.

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