Clinical trial NCT04259437: Gastrointestinal Tolerance of a Nutritional Supplement in Adult Patients With or at Risk of Malnutrition
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastro-Intestinal Tolerance
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2020-02-06
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Gastro-Intestinal Tolerance
timeFrame: Day 1 to Day 7
measure: Nutritional Supplement Palatability
timeFrame: Day 1 to Day 7
measure: Nutritional Supplement Intake
timeFrame: Day 1 to Day 7
measure: Nutritional Supplement Palatability
timeFrame: Day 7
Secondary outcomes:
Other outcomes:
measure: Medications
timeFrame: Baseline to Day 7
measure: Weight
timeFrame: Baseline and Day 7
Locations:
city: Newquay
country: United Kingdom
facility: North Coast Medical Ltd, Newquay Health Centre
state: Cornwall
city: Penzance
country: United Kingdom
facility: Morrab Surgery
state: Cornwall
city: Poole
country: United Kingdom
facility: The Adam Practice
Study officials:
affiliation: Abbott
name: Maria Camprubi Robles, PhD
role: STUDY_CHAIR
References: