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

Abbott

Status

Completed

Conditions

Gastro-Intestinal Tolerance

Treatments

Other: High Protein, Energy Dense Nutritional Supplement

Study type

Interventional

Funder types

Industry

Identifiers

NCT04259437

BL44

Details and patient eligibility

About

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.

Enrollment

46 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.