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

August 24, 2018 updated by: Abbott Nutrition

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

95

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Badalona, Spain, 08916
        • Hospital Universitario Germans Trias i Pujol
      • Barakaldo, Spain, 48903
        • Hospital de Cruces 1758
      • Barakaldo, Spain, 48903
        • Hospital de Cruces 2029
      • Cadiz, Spain, 11407
        • Hospital de Jerez
      • Córdoba, Spain, 14004
        • Hospital Universitario Reina Sofía de Córdoba
      • Granada, Spain, 18016
        • Hospital Universitario Campus de la Salud
      • Leon, Spain, 24080
        • Complejo Asistencial Universitario de Leon, Endocrinologia y Nutricion
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28034
        • Hospital Ramon y Cajal
      • Madrid, Spain, 28805
        • Hospital Universitario Príncipe de Asturias
      • Madrid, Spain, 28935
        • Hospital Universitario de Móstoles
      • Marbella, Spain, 29603
        • Hospital Costa del Sol 1740
      • Marbella, Spain, 29603
        • Hospital Costa del Sol 1743
      • Murcia, Spain, 30003
        • Hospital General Universitario Reina Sofía de Murcia
      • Málaga, Spain, 29007
        • Centro Médico San Juan de la Cruz
      • Móstoles, Spain, 28933
        • Hospital Rey Juan Carlos
      • Orihuela, Spain, 03314
        • Hospital Vega Baja
      • Ponferrada, Spain, 24404
        • Hospital del Bierzo
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocio
      • Valencia, Spain, 46010
        • Hospital Clínico Universitario de Valencia 1695
      • Valencia, Spain, 46600
        • Hospital La Ribera
      • Vic, Spain, 08500
        • Hospital de Vic
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study Product Compliance
Time Frame: Baseline to Week 12
Subject reported diaries
Baseline to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Weight
Time Frame: Baseline to Week 12
Baseline to Week 12
Nutrition Status
Time Frame: Baseline to Week 12
Healthcare Professional completed screening
Baseline to Week 12
Quality of Life
Time Frame: Baseline to Week 12
Subject reported questionnaire
Baseline to Week 12
Gastrointestinal Tolerance
Time Frame: Baseline to Week 12
Subject reported scale
Baseline to Week 12
Body Mass Index
Time Frame: Baseline to Week 12
Baseline to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Nutrition

Investigators

  • Study Chair: Rebecca Sanz Barriuso, RD, PharmD, Abbott Nutrition

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2016

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

February 23, 2016

First Submitted That Met QC Criteria

February 29, 2016

First Posted (Estimate)

March 3, 2016

Study Record Updates

Last Update Posted (Actual)

August 27, 2018

Last Update Submitted That Met QC Criteria

August 24, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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