Skip to main content
Clinical Trials/NCT01902212
NCT01902212
Completed
Not Applicable

Evaluation of an Oral Nutrition Supplement

Abbott Nutrition1 site in 1 country25 target enrollmentJune 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gastrointestinal Tolerance
Sponsor
Abbott Nutrition
Enrollment
25
Locations
1
Primary Endpoint
Gastro-Intestinal Tolerance
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

The objective of this study is to capture gastrointestinal tolerance (GI) information on a nutrient dense oral nutritional supplement (ONS) in healthy elderly subjects.

Registry
clinicaltrials.gov
Start Date
June 2013
End Date
September 2013
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Subjects will be eligible for the study if they meet all of the following inclusion criteria:
  • Male or female ≥ 60 and ≤ 90 years of age.
  • Body Mass Index (BMI) \> 20 but \< 35.

Exclusion Criteria

  • Subjects will be excluded from the study if they meet any of the following criteria:
  • History of diabetes
  • Antibiotic use within 1 week prior to enrollment
  • Undergone major surgery less than 3 months prior to enrollment.
  • Current active malignant disease or was treated within the last 6 months for cancer.
  • Immunodeficiency disorder.
  • Myocardial infarction within the last 3 months.
  • Chronic obstructive pulmonary disease (COPD).
  • Allergy to any of the ingredients in the study product.
  • Obstruction of the gastrointestinal tract or other major gastrointestinal disease.

Outcomes

Primary Outcomes

Gastro-Intestinal Tolerance

Time Frame: Study Day (SD) 1-8

Subject questionnaire

Secondary Outcomes

  • ONS Consumption(SD 1-8)
  • Weight(Screening and SD 8)

Study Sites (1)

Loading locations...

Similar Trials