Clinical trial NCT02698540: A Study of an Oral Nutritional Supplement in a Malnourished Population With GI Tolerance Impairment
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malnutrition
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2016-03-03
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include men and women who are free living (outpatient) or residing in a nursing home.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Study Product Compliance
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Body Weight
timeFrame: Baseline to Week 12
measure: Nutrition Status
timeFrame: Baseline to Week 12
measure: Quality of Life
timeFrame: Baseline to Week 12
measure: Gastrointestinal Tolerance
timeFrame: Baseline to Week 12
measure: Body Mass Index
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Universitario Germans Trias i Pujol
city: Barakaldo
country: Spain
facility: Hospital de Cruces 1758
city: Barakaldo
country: Spain
facility: Hospital de Cruces 2029
city: Cadiz
country: Spain
facility: Hospital de Jerez
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía de Córdoba
city: Granada
country: Spain
facility: Hospital Universitario Campus de la Salud
city: Leon
country: Spain
facility: Complejo Asistencial Universitario de Leon, Endocrinologia y Nutricion
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario Principe de Asturias
city: Madrid
country: Spain
facility: Hospital Universitario de Móstoles
city: Marbella
country: Spain
facility: Hospital Costa del Sol 1740
city: Marbella
country: Spain
facility: Hospital Costa del Sol 1743
city: Murcia
country: Spain
facility: Hospital General Universitario Reina Sofía de Murcia
city: Málaga
country: Spain
facility: Centro Médico San Juan de la Cruz
city: Móstoles
country: Spain
facility: Hospital Rey Juan Carlos
city: Orihuela
country: Spain
facility: Hospital Vega Baja
city: Ponferrada
country: Spain
facility: Hospital del Bierzo
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia 1695
city: Valencia
country: Spain
facility: Hospital La Ribera
city: Vic
country: Spain
facility: Hospital de Vic
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
Study officials:
affiliation: Abbott Nutrition
name: Rebecca Sanz Barriuso, RD, PharmD
role: STUDY_CHAIR
References: