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

Completed

• Conditions: Malnutrition

• Registration Number: NCT02698540
• Lead Sponsor: Abbott Nutrition

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-23
• Study First Submitted QC: 2016-02-29
• Study First Posted: 2016-03-03
• Study Start: 2016-11-28
• Primary Completion: 2018-05
• Study Completion: 2018-05
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-24
• Last Update Posted: 2018-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Study Product Compliance	Baseline to Week 12	Subject reported diaries

Secondary Outcome Measures

Name	Time	Method
Nutrition Status	Baseline to Week 12	Healthcare Professional completed screening
Quality of Life	Baseline to Week 12	Subject reported questionnaire
Body Weight	Baseline to Week 12
Gastrointestinal Tolerance	Baseline to Week 12	Subject reported scale
Body Mass Index	Baseline to Week 12

Trial Locations

Locations (23)

Hospital de Cruces 2029; 🇪🇸 Barakaldo, Spain

Hospital de Jerez; 🇪🇸 Cadiz, Spain

Hospital Universitario Campus de la Salud; 🇪🇸 Granada, Spain

Hospital del Bierzo; 🇪🇸 Ponferrada, Spain

Hospital Universitario Germans Trias i Pujol; 🇪🇸 Badalona, Spain

Hospital Costa del Sol 1740; 🇪🇸 Marbella, Spain

Hospital Costa del Sol 1743; 🇪🇸 Marbella, Spain

Hospital Rey Juan Carlos; 🇪🇸 Móstoles, Spain

Hospital Universitario Reina Sofía de Córdoba; 🇪🇸 Córdoba, Spain

Hospital Ramón y Cajal; 🇪🇸 Madrid, Spain

Complejo Asistencial Universitario de Leon, Endocrinologia y Nutricion; 🇪🇸 Leon, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital de Cruces 1758; 🇪🇸 Barakaldo, Spain

Hospital Universitario Principe de Asturias; 🇪🇸 Madrid, Spain

Hospital Universitario Virgen del Rocío; 🇪🇸 Sevilla, Spain

Hospital de Vic; 🇪🇸 Vic, Spain

Hospital Clínico Universitario de Valencia 1695; 🇪🇸 Valencia, Spain

Hospital La Ribera; 🇪🇸 Valencia, Spain

Hospital Vega Baja; 🇪🇸 Orihuela, Spain

Hospital Universitario Miguel Servet; 🇪🇸 Zaragoza, Spain

Hospital Universitario de Móstoles; 🇪🇸 Madrid, Spain

Centro Médico San Juan de la Cruz; 🇪🇸 Málaga, Spain

Hospital General Universitario Reina Sofía de Murcia; 🇪🇸 Murcia, Spain