Gastrointestinal Tolerance
Conditions
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.
Interventions
OTHEROral Nutritional Supplement
Sponsors
Abbott Nutrition
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 90 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastro-Intestinal Tolerance | Study Day (SD) 1-8 | Subject questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ONS Consumption | SD 1-8 | Consumption Record |
| Weight | Screening and SD 8 | — |
Countries
France
Outcome results
None listed