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

Malnutrition Clinical Trial

Official title:

A Prospective, Observational Study, of a High Calorie, Higher Protein Peptide Based Oral Nutrition Supplement (ONS) With Medium Chain Triglycerides (MCTs) in a Malnourished Population With GI Tolerance Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02698540
• Other study ID #: DA13
• Status: Completed
• Start date: November 28, 2016
• Est. completion date: May 2018

Study information

• Verified date: August 2018
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Malnutrition

Intervention

Other:
• Nutritional Supplement
High calorie, high protein peptide based

Locations

Country	Name	City	State
Spain	Hospital Universitario Germans Trias i Pujol	Badalona
Spain	Hospital de Cruces 1758	Barakaldo
Spain	Hospital de Cruces 2029	Barakaldo
Spain	Hospital de Jerez	Cadiz
Spain	Hospital Universitario Reina Sofía de Córdoba	Córdoba
Spain	Hospital Universitario Campus de la Salud	Granada
Spain	Complejo Asistencial Universitario de Leon, Endocrinologia y Nutricion	Leon
Spain	Hospital Ramón y Cajal	Madrid
Spain	Hospital Universitario de Móstoles	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Principe de Asturias	Madrid
Spain	Centro Médico San Juan de la Cruz	Málaga
Spain	Hospital Costa del Sol 1740	Marbella
Spain	Hospital Costa del Sol 1743	Marbella
Spain	Hospital Rey Juan Carlos	Móstoles
Spain	Hospital General Universitario Reina Sofía de Murcia	Murcia
Spain	Hospital Vega Baja	Orihuela
Spain	Hospital del Bierzo	Ponferrada
Spain	Hospital Universitario Virgen del Rocío	Sevilla
Spain	Hospital Clínico Universitario de Valencia 1695	Valencia
Spain	Hospital La Ribera	Valencia
Spain	Hospital de Vic	Vic
Spain	Hospital Universitario Miguel Servet	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study Product Compliance	Subject reported diaries	Baseline to Week 12
Secondary	Body Weight		Baseline to Week 12
Secondary	Nutrition Status	Healthcare Professional completed screening	Baseline to Week 12
Secondary	Quality of Life	Subject reported questionnaire	Baseline to Week 12
Secondary	Gastrointestinal Tolerance	Subject reported scale	Baseline to Week 12
Secondary	Body Mass Index		Baseline to Week 12