Status:
COMPLETED
Evaluation of an Oral Nutrition Supplement
Lead Sponsor:
Abbott Nutrition
Conditions:
Gastrointestinal Tolerance
Eligibility:
All Genders
60-90 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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.
- Dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder.
- Unintentional weight loss or weight gain ≥ 5% in last 4 weeks.
- Taking medications/dietary supplements/substances that could profoundly modulate metabolism or affect GI motility.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01902212
Start Date
June 1 2013
End Date
September 1 2013
Last Update
March 3 2015
Active Locations (1)
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1
Biofortis Sas
Saint-Herblain, France, 44800