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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02698540

Enrollment

Registered

2016-03-03

Start date

2016-11-28

Completion date

2018-05-31

Last updated

2018-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malnutrition

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.

Interventions

OTHERNutritional Supplement

High calorie, high protein peptide based

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Study Product Compliance	Baseline to Week 12	Subject reported diaries

Secondary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026