NCT04259437CompletedNot Applicable
A Study to Evaluate the Gastrointestinal Tolerance and Acceptability of a High Energy, High Protein Low Volume Oral Nutritional Supplement in Adult Patients With or at Risk of Malnutrition
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Abbott Nutrition
- Enrollment
- 46
- Locations
- 5
- Primary Endpoint
- Gastro-Intestinal Tolerance
Study Overview
Brief Summary
The purpose of this study is to evaluate the GI tolerance, palatability and compliance to a high protein energy-dense oral nutrition supplement in adult patients with or at risk of malnutrition.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject has voluntarily signed and dated informed consent form approved by Independent Ethics Committee and provided applicable privacy authorization prior to any participation in the study.
- •Subject is considered malnourished or at risk for malnutrition
- •Subject has normal GI function
- •Subject requires oral nutritional supplementation ands is willing to comply with the study protocol
Exclusion Criteria
- •Subject has severe dementia, eating disorder, history of significant neurological or psychiatric disorder affecting abilities to answer questions, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures
- •Subject has a history of diabetes
- •Subject is currently taking antibiotics or has taken antibiotics within 1 week prior to enrollment
- •Subject has undergone major GI surgery less than 3 months prior to enrollment
- •Subject has active malignant disease or was treated within the last 6 months for cancer
- •Subject has immunodeficiency disorder
- •Subject has had a myocardial infarction within the last 3 months prior to enrollment
- •Subject is known to be allergic to intolerant to an ingredient found in the study product
- •Subject has an aversion to the flavor of product being tested
- •Subject has an obstruction of the GI tract precluding ingestion or absorption of the study product, inflammatory bowel disease, gastric esophageal reflux disease, short bowel syndrome, or other major gastro-intestinal disease-causing symptoms including but not limited to uncontrollable severe diarrhea, nausea, or vomiting
- •Subject is taking medications/dietary supplements/substances that could profoundly modulate metabolism or affect gastrointestinal motility.
- •Participation in another study that has not yet been approved as a concomitant study by the Sponsor.
- •Subject has a clinical condition that is contraindicated with this product.
- •Subject is pregnant.
Outcomes
Primary Outcomes
Gastro-Intestinal Tolerance
Time Frame: Day 1 to Day 7
Subject completed Bristol Stool Type questionnaire; Stool is classified into 7 groups (Types 1-7) with Type 3-4 as ideal stools.
Nutritional Supplement Intake
Time Frame: Day 1 to Day 7
Subject completed daily intake questionnaire including amount of Bottle 1 and Bottle 2 consumed
Nutritional Supplement Palatability
Time Frame: Day 7
Subject completed 6, Likert Scale questions; 4 scaled in the negative direction; 2 scaled from Far Too to Not at all Enough for additional flavors
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (5)
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