A Study of an Oral Nutritional Supplement in a Malnourished Population With GI Tolerance Impairment
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
1 other identifier
observational
95
1 country
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2016
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2016
CompletedFirst Posted
Study publicly available on registry
March 3, 2016
CompletedStudy Start
First participant enrolled
November 28, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedAugust 27, 2018
August 1, 2018
1.4 years
February 23, 2016
August 24, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Study Product Compliance
Subject reported diaries
Baseline to Week 12
Secondary Outcomes (5)
Body Weight
Baseline to Week 12
Nutrition Status
Baseline to Week 12
Quality of Life
Baseline to Week 12
Gastrointestinal Tolerance
Baseline to Week 12
Body Mass Index
Baseline to Week 12
Interventions
High calorie, high protein peptide based
Eligibility Criteria
The study population will include men and women who are free living (outpatient) or residing in a nursing home.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbott Nutritionlead
Study Sites (23)
Hospital Universitario Germans Trias i Pujol
Badalona, 08916, Spain
Hospital de Cruces 1758
Barakaldo, 48903, Spain
Hospital de Cruces 2029
Barakaldo, 48903, Spain
Hospital de Jerez
Cadiz, 11407, Spain
Hospital Universitario Reina Sofía de Córdoba
Córdoba, 14004, Spain
Hospital Universitario Campus de la Salud
Granada, 18016, Spain
Complejo Asistencial Universitario de Leon, Endocrinologia y Nutricion
León, 24080, Spain
Hospital Ramón y Cajal
Madrid, 28034, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Universitario Principe de Asturias
Madrid, 28805, Spain
Hospital Universitario de Móstoles
Madrid, 28935, Spain
Hospital Costa del Sol 1740
Marbella, 29603, Spain
Hospital Costa del Sol 1743
Marbella, 29603, Spain
Centro Médico San Juan de la Cruz
Málaga, 29007, Spain
Hospital Rey Juan Carlos
Móstoles, 28933, Spain
Hospital General Universitario Reina Sofía de Murcia
Murcia, 30003, Spain
Hospital Vega Baja
Orihuela, 03314, Spain
Hospital del Bierzo
Ponferrada, 24404, Spain
Hospital Universitario Virgen del Rocío
Seville, 41013, Spain
Hospital Clínico Universitario de Valencia 1695
Valencia, 46010, Spain
Hospital La Ribera
Valencia, 46600, Spain
Hospital de Vic
Vic, 08500, Spain
Hospital Universitario Miguel Servet
Zaragoza, 50009, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Rebecca Sanz Barriuso, RD, PharmD
Abbott Nutrition
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2016
First Posted
March 3, 2016
Study Start
November 28, 2016
Primary Completion
May 1, 2018
Study Completion
May 1, 2018
Last Updated
August 27, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share