NCT01902212
Completed
Not Applicable
Evaluation of an Oral Nutrition Supplement
ConditionsGastrointestinal Tolerance
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.
Investigators
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)
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