Evaluation of an Oral Nutrition Supplement
Not Applicable
Completed
- Conditions
- Gastrointestinal Tolerance
- Registration Number
- NCT01902212
- Lead Sponsor
- Abbott Nutrition
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Gastro-Intestinal Tolerance Study Day (SD) 1-8 Subject questionnaire
- Secondary Outcome Measures
Name Time Method ONS Consumption SD 1-8 Consumption Record
Weight Screening and SD 8
Trial Locations
- Locations (1)
Biofortis Sas
🇫🇷Saint Herblain, France
Biofortis Sas🇫🇷Saint Herblain, France