Gastro-intestinal Tolerance
Conditions
Brief summary
The objective of this study is to evaluate gastrointestinal tolerance of an oral nutritional supplement containing a new protein blend in healthy elderly subjects.
Interventions
Supplement contains a new protein mix consisting of a blend of milk, soy, and pea protein.
Sponsors
Abbott Nutrition
Study design
Allocation
NON_RANDOMIZED
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: 1. Age ≥ 60 and ≤ 90 years 2. Body Mass Index (BMI) \> 20 but \< 35
Exclusion criteria
Subjects will be excluded from the study if they meet any of the following criteria: 1. History of diabetes 2. Currently taking or has taken antibiotic within 1 week prior to enrollment 3. Major surgery less than 3 months prior to enrollment in the study 4. Current active malignant disease or was treated within the last 6 months for cancer 5. Immunodeficiency disorder 6. Myocardial infarction within the last 3 months prior to enrollment 7. Chronic obstructive pulmonary disease (COPD) 8. Allergy to any of the ingredients in the study product 9. Aversion to flavor of product being tested 10. Obstruction of the gastrointestinal tract precluding ingestion or absorption of the study product, inflammatory bowel disease, ulcer, gastric reflux disease, short bowel syndrome, or other major gastrointestinal disease 11. Dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder 12. Pursuing or has unintentional weight loss or weight gain ≥ 5% in last 4 weeks 13. 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 1-7 | Self-reported questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Study Product Compliance | Study Day 1-7 | Self-reported number of containers consumed per day |
| Weight | Study Day 1 and 8 | — |
Countries
United States
Outcome results
None listed