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CompletedNCT02698540Updated Aug 27, 2018

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

An observational study in Malnutrition, sponsored by Abbott Nutrition. Completed at 23 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-27.

Sponsored by Abbott Nutrition · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
95
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Malnutrition

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03

In context

Malnutrition

1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.

This study's enrollment of 95 is below the median of 203 across 388 observational studies indexed under Malnutrition.

Browse Malnutrition studies →

Lead sponsor

Abbott Nutrition is the lead sponsor of 153 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
95 participants (actual)
Patient registry
No

Interventions

  • OtherNutritional Supplement

    High calorie, high protein peptide based

06

What researchers measure

Primary outcomes

  1. Study Product Compliance

    Subject reported diaries

    Time frame: Baseline to Week 12

Secondary outcomes

  1. Body Weight

    Time frame: Baseline to Week 12

  2. Nutrition Status

    Healthcare Professional completed screening

    Time frame: Baseline to Week 12

  3. Quality of Life

    Subject reported questionnaire

    Time frame: Baseline to Week 12

  4. Gastrointestinal Tolerance

    Subject reported scale

    Time frame: Baseline to Week 12

  5. Body Mass Index

    Time frame: Baseline to Week 12

07

Study locations

23 sites
  • 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
    Leon, 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
  • Hospital General Universitario Reina Sofía de Murcia
    Murcia, 30003, Spain
  • Centro Médico San Juan de la Cruz
    Málaga, 29007, Spain
  • Hospital Rey Juan Carlos
    Móstoles, 28933, Spain
  • Hospital Vega Baja
    Orihuela, 03314, Spain
  • Hospital del Bierzo
    Ponferrada, 24404, Spain
  • Hospital Universitario Virgen del Rocío
    Sevilla, 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
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02698540
Lead sponsor
Abbott Nutrition
Responsible party
Sponsor
First posted
Mar 3, 2016
Start date
Nov 28, 2016
Primary completion
May 2018
Completion
May 2018
Last update
Aug 27, 2018

Study contacts

Rebecca Sanz Barriuso, RD, PharmD
study chair · Abbott Nutrition

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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