Evaluation of an Oral Nutritional Supplement
Completed · Not applicable
Conditions studied: Gastro-intestinal Tolerance
In brief
The objective of this study is to evaluate gastrointestinal tolerance of an oral nutritional supplement containing a new protein blend in healthy elderly subjects.
Key facts
- Study ID
- NCT01781624
- Run by
- Abbott Nutrition
- People needed
- 25
- Starts
- 2012-10-01
- Expected to finish
- 2012-11-01
- Last updated by the study team
- 2013-02-01
Who can join
Age: 60 and older, up to 90. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Subjects will be eligible for the study if they meet all of the following inclusion criteria:
- Age ≥ 60 and ≤ 90 years
- Body Mass Index (BMI) > 20 but < 35
You may not qualify if…
- Subjects will be excluded from the study if they meet any of the following criteria:
- History of diabetes
- Currently taking or has taken antibiotic within 1 week prior to enrollment
- Major surgery less than 3 months prior to enrollment in the study
- Current active malignant disease or was treated within the last 6 months for cancer
- Immunodeficiency disorder
- Myocardial infarction within the last 3 months prior to enrollment
- Chronic obstructive pulmonary disease (COPD)
- Allergy to any of the ingredients in the study product
- Aversion to flavor of product being tested
- 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
- Dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder
- Pursuing or has unintentional weight loss or weight gain ≥ 5% in last 4 weeks
- Medications/dietary supplements/substances that could profoundly modulate metabolism or affect GI motility
Where it is running
- Radiant Research, Inc. — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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