Gastrointestinal Tolerance of a Nutritional Supplement in Adult Patients With or at Risk of Malnutrition

Study Overview
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Brief Summary
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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.

Official Title
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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
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Gastro-Intestinal Tolerance

Intervention / Treatment
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* Other: High Protein, Energy Dense Nutritional Supplement


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Protein, Energy Dense Nutritional Supplement<br>2 servings per day | Other: High Protein, Energy Dense Nutritional Supplement<br>* Ready to drink oral supplement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastro-Intestinal Tolerance | Subject completed Bristol Stool Type questionnaire; Stool is classified into 7 groups (Types 1-7) with Type 3-4 as ideal stools. | Day 1 to Day 7 | 
| Nutritional Supplement Palatability | Subject completed 6, Likert Scale questions; 4 scaled in the negative direction; 2 scaled from Far Too to Not at all Enough | Day 1 to Day 7 | 
| Nutritional Supplement Intake | Subject completed daily intake questionnaire including amount of Bottle 1 and Bottle 2 consumed | Day 1 to Day 7 | 
| Nutritional Supplement Palatability | 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 | Day 7 |