Evaluation of a High Protein, High Calorie Pudding in Adults With/or at Risk for Malnutrition

Study Overview
=================
Brief Summary
-----------------
This is a multi-center, prospective, non-randomized, non-blinded, single-arm, single treatment study to evaluate the tolerance of a nutritional pudding.

Official Title
-----------------
Gastrointestinal Tolerance and Acceptability of a High Protein, High Calorie Pudding in Adult Patients With/or at Risk for Malnutrition

Conditions
-----------------
Gastrointestinal Tolerance

Intervention / Treatment
-----------------
* Other: Experimental Nutritional Pudding


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has voluntarily signed and dated an ICF approved by an IEC, and provided applicable privacy authorization prior to any participation Subject is considered by a dietitian or clinician as malnourished or at risk for malnutrition based on current use of an oral nutritional supplement (ONS), recently identified as malnourished or at risk of malnutrition based on validated malnutrition screening tool or has had weight loss within last two months as a result of a hospitalization or chronic illness Subject currently has normal GI function Subject requires ONS and is willing to comply with the study protocol Exclusion Criteria: Subject has severe dementia or delirium, 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 had a history of diabetes as evidenced by taking antihyperglycemic medications or by self-reported dietary modification Subject is currently taking or has taken antibiotics within 1 week prior to enrollment Subject has undergone major GI surgery less than 3 months prior to enrollment in the study Subject has current active malignant disease or was treated within the last 6 months for cancer, except basal or squamous cell skin carcinoma, prior to enrollment Subject has an immunodeficiency disorder Subject has had a myocardial infarction within the last 3 months prior to enrollment Subject is known to be allergic or intolerant to any ingredient found in the study product Subject has an aversion to any of the flavours 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 gastrointestinal disease-causing symptoms including (but not limited to) uncontrollable severe diarrhea, nausea, or vomiting Subject is currently taking medications/dietary supplements/substances that could profoundly modulate metabolism or affect gastrointestinal motility Participation in another study that has not been approved as a concomitant study Subject has a clinical condition that is contraindicated with this product as determined by the clinician in accordance with standard of care Subject is pregnant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Nutritional Pudding<br>2 servings per day | Other: Experimental Nutritional Pudding<br>* High Calorie, High Protein pudding<br>|

What is the study measuring?
-----------------
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 | Study Day 1 to Study Day 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional Supplement Palatability | Subject completed questionnaire; 4 questions scaled from 1 -Dislike Extremely to 9-Like Extremely; 2 questions scaled from Not at all Enough to Far Too | Study Day 1 to Study Day 8 | 
| Nutritional Supplement Compliance | Subject completed daily intake questionnaire including amount of serving consumed | Study Day 1 to Study Day 28 |