Gastrointestinal Tolerance
Conditions
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.
Interventions
OTHERExperimental Nutritional Pudding
High Calorie, High Protein pudding
Sponsors
Abbott Nutrition
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastro-Intestinal Tolerance | Study Day 1 to Study Day 8 | Subject completed Bristol Stool Type questionnaire; Stool is classified into 7 groups (Types 1-7) with Type 3-4 as ideal stools |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nutritional Supplement Compliance | Study Day 1 to Study Day 28 | Subject completed daily intake questionnaire including amount of serving consumed |
| Nutritional Supplement Palatability | Study Day 1 to Study Day 8 | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | Baseline to Study Day 28 | Subject reported adverse events |
| Height | Baseline to Study Day 28 | For BMI Calculation |
| Weight | Baseline to Study Day 28 | For BMI Calculation |
| Medication Usage | Baseline to Study Day 28 | Subject reported medication usage |
Countries
United Kingdom
Outcome results
None listed