A Study of an Oral Nutritional Supplement in a Malnourished Population With GI Tolerance Impairment
NCT ID: NCT02698540
Last Updated: 2018-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
95 participants
OBSERVATIONAL
2016-11-28
2018-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Nutritional Supplement
High calorie, high protein peptide based
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Abbott Nutrition
INDUSTRY
Responsible Party
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Principal Investigators
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Rebecca Sanz Barriuso, RD, PharmD
Role: STUDY_CHAIR
Abbott Nutrition
Locations
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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
León, , Spain
Hospital Ramón y Cajal
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Principe de Asturias
Madrid, , Spain
Hospital Universitario de Móstoles
Madrid, , Spain
Hospital Costa del Sol 1740
Marbella, , Spain
Hospital Costa del Sol 1743
Marbella, , Spain
Centro Médico San Juan de la Cruz
Málaga, , 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
Seville, , Spain
Hospital Clínico Universitario de Valencia 1695
Valencia, , Spain
Hospital La Ribera
Valencia, , Spain
Hospital de Vic
Vic, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Countries
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Other Identifiers
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DA13
Identifier Type: -
Identifier Source: org_study_id
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