Gastrointestinal Tolerance of a Nutritional Supplement in Adult Patients With or at Risk of Malnutrition
Not Applicable
Completed
- Conditions
- Gastro-Intestinal Tolerance
- Interventions
- Other: High Protein, Energy Dense Nutritional Supplement
- Registration Number
- NCT04259437
- Lead Sponsor
- Abbott Nutrition
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description High Protein, Energy Dense Nutritional Supplement High Protein, Energy Dense Nutritional Supplement 2 servings per day
- Primary Outcome Measures
Name Time Method Gastro-Intestinal Tolerance 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 Day 1 to Day 7 Subject completed daily intake questionnaire including amount of Bottle 1 and Bottle 2 consumed
Nutritional Supplement Palatability 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 Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
The Adam Practice
🇬🇧Poole, United Kingdom
North Coast Medical Ltd, Newquay Health Centre
🇬🇧Newquay, Cornwall, United Kingdom
Morrab Surgery
🇬🇧Penzance, Cornwall, United Kingdom