A Study of an Oral Nutritional Supplement in a Malnourished Population With GI Tolerance Impairment

Abbott

Status: Completed

Conditions: Malnutrition

Treatments: Other: Nutritional Supplement

Study type: Observational

Funder types: Industry

Identifiers

NCT02698540

DA13

Details and patient eligibility

About

The purpose is to observe the compliance to a high-calorie, high protein peptide-based nutritional supplement after 3 months in a malnourished population with impaired gastrointestinal tolerance living in nursing homes and as outpatients.

Enrollment: 95 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject is considered malnourished, or is at risk for malnutrition based on MUST score ≥2.
• Subject is ≥18 years old.
• Subject has a condition that would benefit from a high calorie, higher protein ONS for GI tolerance impairment (e.g., diarrhea, nausea, vomiting, satiety or bloating).
• Subject conforms to the requirements set forth on the study product label.
• Subject is under the care of a health care professional for malnutrition and has recently (within the last 7 days prior to participating in this study) been prescribed 2 servings/day of the study ONS. Subject must have been naïve to ONS for GI tolerance impairment prior to being prescribed the study ONS.

Exclusion criteria

• The study physician determines the subject is not fit to participate
• Subject cannot provide informed consent to participate in the study.
• Subject cannot safely consume the oral nutritional supplement.
• Renal or liver failure (GFR< 60 ml/min or AST/ALTx3 normal) upper limit.
• Type 1 or type 2 diabetes.